Atorvastatin Therapy in the Treatment of Dyslipidemia in Children With Steroid Sensitive Nephrotic Syndrome
Phase: PHASE4
Conditions: Dyslipidaemia
Sponsor: National Institute of Kidney Disease and Urology (NIKDU)

 
 
1 
 
 
 
 
 
Title: Atorvastatin therapy in the treatment 
of dyslipidemia in children with steroid 
sensitive nephrotic syndrome 
 
Date : 27th January 2024 
 
NCT number : ID not yet assigned 
 
 
 
 
 
 
 
 
 
 
 

 
 
2 
                                          INTRODUCTION 
 
Nephrotic syndrome is the most common childhood kidney disease. Nephrotic syndrome (NS) is 
defined by massive proteinuria & hypoalbuminemia with resulting edema & hyperlipidemia 
(Boyer et al. 2017). Dyslipidemia has long been recognized as a frequent metabolic abnormality 
in patients with nephrotic syndrome, having first been documented in 1917 (Benakappa et al. 
1976). Hyperlipidemia is an important characteristic of idiopathic nephrotic syndrome in 
children. Abnormal lipid metabolism is common in patients with nephrotic syndrome where 
hypercholesterolemia with hypertriglyceridemia is seen in 90% & 98 % of cases respectively 
(Vaziri ND.et al 2018). Hyperlipidemia occurs because of increase hepatic synthesis of 
lipoprotein due to hypoalbuminemia and decreased catabolism of individual lipid fraction due to 
loss of lipoprotein lipase and lipoprotein lipase receptor and due to drugs used (steroid, 
cyclosporine, tacrolimus) in the treatment of nephrotic syndrome. Hyperlipidemia is usually 
observed during the active phase of the disease and disappears with resolution of proteinuria 
(Merouni et al 2003). Nephrotic syndrome results in deficiencies in peripheral tissue 
lipoprotein lipase activity, hepatic lipase activity, and hepatic VLDL receptors, as well as 
increased levels of cholesteryl ester transfer protein and lipoprotein receptor related protein. 
These abnormalities cause reduced lipolysis of VLDL and chylomicrons, resulting in 
hypertriglyceridemia, increased VLDL, impaired clearance of chylomicrons, and postprandial 
lipemia in NS. The plasma concentrations of total cholesterol (CH), triglyceride (TG), low 
density lipoprotein (LDL), very low-density lipoprotein (VLDL), apolipoprotein-b and 
lipoprotein(a) are increased during active phase of the disease. But despite the disappearance of 
proteinuria, hyperlipidemic profiles were present in nearly half of nephrotic patients at remission 
(Me´rouani et al 2003). Persistent hyperlipidemia after remission can be found in frequent 
relapse nephrotic syndrome and steroid resistant nephrotic syndrome (Querfield et al 1999). 
Dyslipidemia is a risk factor for atherosclerosis, hence, children with NS have a higher risk for 
vascular disease due to atherosclerosis (Agrawal et al 2018) Therefore, children with unremitting 
NS have marked dyslipidemia that likely greatly increases their risk for future cardiovascular 
complications (Hari. P et al 2020). Dyslipidemia may also aggravate glomerulosclerosis and 
contribute to progression of renal injury (Hari, P et al 2018). The persistence and severity of lipid 
changes in serum correlates well with the duration and frequency of the relapses, even during the 

 
 
3 
remission which leads to increased risk of atherosclerosis in later life and the development of 
progressive renal injury (Su x et al 2015). Although nearly all patients with nephrotic syndrome 
experience dyslipidemia, patients who have frequent relapses or have steroid-resistant nephrotic 
syndrome (SRNS) are most at risk from the associated biochemical changes (Querfield et al 
1999). Hence, dyslipidemia is an important modifiable risk factor, the treatment of which has 
become an issue, increasingly important as long-term survival among patients with nephrotic 
syndrome continues to improve (Warady BAet al 2015). Therapy with antihyperlipidemic agents 
during childhood may be of considerable benefit in the nephrotic syndrome patient population to 
prevent such damage from occurring (Nishi S et al 2016). Hydroxymethylglutaryl coenzyme A 
(HMG-CoA) reductase inhibitors (statins), the most potent cholesterol-reducing agents available, 
are currently the first-line pharmacologic therapy for adult hyperlipidemia in glomerular disease 
(KDIGO 2021 clinical practice guideline) but no such evidenced based guideline is established 
in case of pediatric management of dyslipidemia in nephrotic syndrome. Statins are more 
effective at correcting the lipid profile than use of dietary restriction of fats and cholesterol alone, 
in patients with glomerular disease, in particular nephrotic syndrome. (Pediatric nephrology On-
The-Go 4th edition). HMG-CoA reductase catalyzes the rate-limiting step in cholesterol 
biosynthesis, in which HMG-CoA is converted to mevalonate. Statins act primarily in the liver 
where a compensatory increase in low-density lipoprotein receptor expression results in an 
increase in the hepatic clearance of low-density lipoprotein cholesterol (LDL-C). Accompanying 
this reduction in LDL-C, statins also decrease very-low-density lipoprotein cholesterol (VLDL-
C) and triglyceride levels and increase high-density lipoprotein cholesterol (HDL-C) levels. 
Besides the lipid-lowering effect, statins have been suggested to inhibit the development of 
cardiovascular disease through anti-inflammatory, antioxidant, vascular endothelial function-
improving, plaque-stabilizing, and platelet aggregation-inhibiting effects (Morufuji et al 2022) 
Taking these actions into consideration and given the significant cholesterol reduction needed 
with nephrotic syndrome dyslipidemia, statins appear to be a promising therapeutic option. As 
with other statins, atorvastatin is a competitive inhibitor of HMG-CoA reductase. Also, it is on 
the WHO list of essential medicines. 
We therefore propose to examine, in a prospective quasi experimental study, whether 
administration of atorvastatin is effective in improving dyslipidemia in children with steroid 
sensitive nephrotic syndrome.  
 

 
 
4 
RATIONALE OF THE STUDY 
Dyslipidemia secondary to nephrotic syndrome resulting from several pathophysiology may 
persist in some children both in relapse and remission. Dyslipidemia is an important modifiable 
risk factor that may also aggravate glomerulosclerosis and contribute to progression of renal 
injury. Usually, dyslipidemia resolves with disease remission in some steroid responsive patients 
with dietary modification. But Serum cholesterol, triglyceride and low-density lipoprotein which 
were elevated during active disease, may also remain elevated even after urinary remission, in 
some different types of steroid sensitive Nephrotic Syndrome.  
Dyslipidemia plays a part in the increased rate of atherosclerosis in patients with nephrotic 
syndrome, which in turn increases the risks of multiple cardiovascular morbidities, including 
stroke, myocardial infarction and thrombosis. More importantly, dyslipidemia itself causes renal 
injury, which, if not interrupted, contributes to progressive CKD and, ultimately, the 
development of end-stage renal disease in some patients. 
 
Many studies have been done on the outcome of statin therapy in adult nephrotic syndrome. But 
in the pediatric population such studies are very few. So, the proposed study was designed to see 
the outcome of atorvastatin therapy in children with steroid sensitive nephrotic syndrome. 
 
 
 
RESEARCH QUESTION 
 
Is Atorvastatin beneficial for the treatment of dyslipidemia in 
steroid sensitive Nephrotic Syndrome in children? 
 
 
HYPOTHESIS 
 
Atorvastatin is needed in the treatment of dyslipidemia in steroid 
sensitive Nephrotic Syndrome in children.  
 
 

 
 
5 
OBJECTIVES 
 
 
General objective: To see the outcome of Atorvastatin therapy in children with dyslipidemia 
in steroid sensitive nephrotic syndrome.   
 
 
 
Specific objective 
1. To measure the serum lipid profile (total cholesterol, triglyceride, LDL, VLDL, and 
HDL) in nephrotic childs'  of both groups. 
2. To compare the serum lipid profile (total cholesterol, triglyceride, LDL, VLDL, and 
HDL) in nephrotic childs'  of both groups.   
3. To see the effectiveness of atorvastatin therapy in intervention group by comparing with 
control group.  
4. To look for the side effects of atorvastatin in intervention group. 
 
 
 
 
 
 
 
 
 

 
 
6 
                                              MATERIALS & METHODS 
 
Study type 
Quasi Experimental Study   
 
Place of study 
This study will be conducted at the department of Pediatric Nephrology & Nephrology 
department, National Institute of Kidney Diseases & Urology, Sher-E-Bangla Nagar, Dhaka  
 
 
Period of study 
The study period for this study is from December 2023 to August 2025. 
 
Study population 
Indoor and outdoor patients of different types of steroid sensitive nephrotic syndrome at 
Pediatric Nephrology department & Nephrology department of National Institute of Kidney 
Diseases. 
 
Sampling method: 
Consecutive children who fulfilled the inclusion criteria during study period will be enrolled then 
categorized into different groups by simple randomization.    
 
 

 
 
7 
SELECTION CRITERIA 
 
Inclusion criteria 
Children aged 8-18 years of both sexes with known case of Steroid Sensitive Nephrotic 
Syndrome with LDL ≥ 130 mg/dl in consecutive serum fasting lipid profile at least 1 week apart   
while on remission. 
 
 
Exclusion criteria 
 Children with previously diagnosed hyperlipidemia other than Nephrotic Syndrome. 
 Children with steroid resistant nephrotic syndrome  
 Children already on lipid lowering drugs  
 Secondary nephrotic syndrome.  
 Those parents/patients who refused to participate. 
 
 
 
 
 
 
 
 
 
 

 
 
8 
 
Sample size 
The sample size was determined by following formula 
 
Here, n= sample size 
µ1 = 115.8 [Mean LDL of IFRNS group (Hoque et al., 2022)] 
µ2 =153.2 [Mean LDL of FRNS group (Hoque et al., 2022)] 
σ1 = 38.8 [SD of LDL of IFRNS group (Hoque et al., 2022)] 
σ2 = 43.9 [SD of LDL of FRNS group (Hoque et al., 2022)] 
Zα = 1.96 at a 95% confidence interval 
Zβ = 0.85 at a 80% power 
Putting the values in the above equation the sample size n is estimates as 
 
Sample size will be 20 in each group. 
Hoque, S.S., Islam, M.A., Akter, T., Roy, R.R. and Rahman, M.H., 2022. Comparison of Lipid Profile in 
Different Types of Steroid Sensitive Idiopathic Relapsing Nephrotic Syndrome in Children during Active 
Disease and Remission. Medicine Today, 34(2), pp.111-116. 
 
 
 
 

 
 
9 
METHODOLOGY OF DATA COLLECTION 
This is a prospective quasi experimental study. Children aged 8-18 years with steroid sensitive 
nephrotic syndrome with LDL ≥ 130 mg/dl in consecutive serum fasting lipid profile at least 1 
week apart, while on remission, will be enrolled based on selection criteria. Informed written 
consent will be taken from the parents. Ethical clearance will be obtained from the institutional 
ethical committee. On entry into the study a detailed history will be taken & proper physical 
examinations will be done. Routine investigations such as complete blood count, CRP, serum 
albumin, serum lipid profile, serum creatinine, Spot Urine PCR /24 hours UTP, urine routine 
examination and culture, X-ray chest will be done. Infection will be screened out and appropriate 
measures will be taken.  
Patients who are eligible will be categorized for general dietary advice for nephrotic syndrome 
into (Group –A) and dietary advice with atorvastatin therapy (for Group- B) using a non-
randomized method (odd number getting only dietary advice and even number getting dietary 
advice with atorvastatin). Dietary advice will be provided by dietician of NIKDU.  Atorvastatin 
will be given according pediatric practice guidelines (0.3mg-0.5mg/kg/day ; max dose 
1.6mg/kg/day) for 3 months. 
Both groups will be followed up at 1 month and at 3 months from intervention. In each follow-up 
visit the following parameters will be observed, such as response to treatment of both groups and 
to see if there are any side effects of atorvastatin therapy.  
The results will be documented in a predesigned data sheet for statistical analysis.   
 
Chi-square, paired t-test and ANOVA test will be done whenever required 
Relative risks, odds ratios, or hazard ratios. Pooled risk ratios (RRs) and 95 % confidence 
intervals (CIs) will be calculated. 
Demographic variable of patient 
Baseline and clinical characteristics 
Gender: Male/ Female 
Age  
Rural/Urban 
 

 
 
10 
Clinical variable 
Weight 
Height 
BMI 
Temperature 
Blood Pressure 
Respiratory rate and chest findings   
BSUA 
Oedema 
Ascites 
Hepatomegaly 
Muscle tenderness 
 
Laboratory variable 
CBC 
CRP 
S. creatinine 
Urine R/M/E and Culture   
Spot Urinary PCR/ 24 hours UTP 
S. Albumin 
S. Fasting Lipid Profile 
Chest X ray 
SGPT 
RBS 
CPK MB (only for intervention group) 
 

 
 
11 
ETHICAL IMPLICATIONS 
 
 Ethical clearance for the study will be taken from the ethical committee of NIKDU.   
 Parents of every study subject will be informed about the nature, purpose and implications of 
the study.   
 Subjects will be assured of their confidentiality and freedom to withdraw from the study 
anytime.  
 Written consent will be taken from all parents without any influences prior to study and 
without exploiting any weakness of the subjects. 
 
 
 
 
                                      QUALITY ASSURANCE 
 
Training and piloting: Under guidance of supervisor and/co-supervisor collected data will be 
verified and cross-checked by supervisor and co-supervisor. 
 
Study procedure 
This will be a prospective quasi experimental study and will be conducted in the Department of 
Pediatric Nephrology & Nephrology Department of NIKDU, from December 2023 to August 
2025. who had fulfilled inclusion criteria will be enrolled. Ethical clearance will be obtained 
from the institutional ethical committee of NIKDU. Quality assurance measurements will be 
recorded with a semi structured questionnaire. Informed written consent will be taken from the 
parents. All patients will be interviewed by structured questionnaire. Participants will have every 
right to withdraw themselves from the study at any point in time. Ethical issues will be addressed 
to every patient.  
 
Protocol writing and taking ethical clearance 
↓ 
Enrollment of patients (based on selection criteria) 
↓ 
Semi structured data sheet to be fulfilled 
↓ 
Physical findings & Lab information 
↓ 
Entry of data and then analysis of data 
↓ 
Reporting of the results 
 
 

 
 
12 
 
Research instruments 
 
For data collection:  Semi structured data sheet containing- 
 Demography of the patient. 
 Laboratory investigations. 
 
 
 
 
 
 
Statistical analysis 
 
 Qualitative variables (sex) of these studies will be expressed as percentage. 
 Quantitative variable (age) will be expressed as mean ± standard deviation.  
 Numerical variables will be presented as mean, median and standard deviation.  
 Continuous data will be analyzed using the Mann–Whitney U test, whereas categorical 
data will be investigated using the chi-square test.   
 Differences between the two groups at the end of 3 months will be determined using 
Kaplan–Meier curves.  A p value of <0.05 will be considered significant. 
 
 
 
 
 
 
 

 
 
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OPERATIONAL DEFINITIONS 
 
 
These are applicable for this study.  
Nephrotic Syndrome (NS): NS is characterized by nephrotic range proteinuria (urinary protein 
creatinine ratio >2mg/mg or 3+ dipstick) and either hypoalbuminemia (serum albumin <3 g/dl) 
or edema (KDIGO 2021).  
Remission: Protein free urine (urine protein negative or trace or <4mg/m²/hr) for 3 consecutive 
days (Bagga and Srivastava, 2016).  
Relapse: Recurrence of nephrotic range proteinuria (urine protein 3+ or more) for 3 consecutive 
days. (KDIGO 2021) 
Steroid Sensitive Nephrotic Syndrome: Complete remission after 4 weeks of prdenisolone or 
prednisolone at standard dose. (KDIGO 2021) month period. (KDIGO 2021) 
Infrequent Relapse nephrotic syndrome (IFRNS): <2 relapses per 6 months within 6 months 
of disease onset or < 4 relapses per 12 months in any subsequent 12- 
Frequent relapse nephrotic syndrome (FRNS): ≥2 relapses per 6 months within 6 months of 
disease onset or ≥ 4 relapses per 12 months in any subsequent 12-month period. (KDIGO 2021) 
Steroid dependent nephrotic syndrome (SDNS): Occurrence of 2 consecutive relapses during 
therapy with prednisolone or prednisolone (either at full dose or tapering) or within 15 days of 
prednisolone or prednisolone discontinuation. (KDIGO 2021) 
Steroid resistant nephrotic syndrome (SRNS): Lack of complete remission at 4 weeks of 
therapy with daily prednisolone or prednisolone at standard dose. (KDIGO 2021) 
BMI: Weight in kg/Height in squared meter.  
Normal BMI: 5th to 85th percentile for age and gender according to CDC growth chart.  
Hyperlipidemia: An increase in one or more of the plasma lipids levels. Serum total cholesterol 
≥200mg/dl, LDL cholesterol ≥130 mg/dl, triglyceride ≥130 mg/dl, and HDL >45mg/dl 
acceptable, 35-45 borderline, <35 low (Kwiterovich, 2008).  
Dyslipidemia: is an abnormal amount of lipids (e.g.: triglycerides, cholesterol and/or fat 
phospholipids) in the blood. (Kwiterovich, 2008) 
 

 
 
14 
Hypertension: Systolic or diastolic blood pressure value above the 95th percentile for age, 
gender and height considered as hypertensive and Systolic or diastolic blood pressure value 
below the 90th percentile considered as normotensive (Bagga and Srivastava, 2016). Or parents 
reported previous diagnosis of hypertension by physician and taking anti-hypertensive 
medication.  
Hyperglycemia: Random serum glucose ≥7.8 mmol/L.  
Free of acute infection: No clinical sign of infection, normal body temperature, no foci of 
inflammation in the body, total and differential leucocyte count within normal range 4000 -
11,000/mm3, CRP ≤10mg/L 
Normal SGPT: 10 - 45IU/L 
Normal CPK MB: 5- 25 IU/L  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
15 
REFERENCE 
Agrawal, S., Zaritsky, J.J., Fornoni, A. & Smoyer, W.E., 2018. Dyslipidaemia in nephrotic 
syndrome: mechanisms and treatment. Nature Reviews Nephrology, 14(1), 57–70. 
Bagga, A., Srivastava, R.N.,2016.Pediatric Nephrology.6th ed. New Delhi:Jaypee. 
Benakappa, DG, Subba, Rao, A, Sastry. " Low density lipoprotein levels in children with 
nephrotic syndrome". Indian pediatrics. 1976; 13 ( 4) : 287-89. 8 
Boyer, O., Baudouin, V., Bérard, E., Dossier, C., Audard, V., Guigonis, V., et al., 2017. 
Idiopathic nephrotic syndrome. Pediatric Archives, 24(12), 1338–1343.  
Hari P, Khandelwal P, Smoyer WE. Dyslipidemia and cardiovascular health in childhood 
nephrotic syndrome. Pediatr Nephrol. 2020; 35:1601–19 
Hari P, Khandelwal P, Satpathy A, Hari S, Thergaonkar R, Lakshmy R, Sinha A, Bagga A. 
Effect of atorvastatin on dyslipidemia and carotid intima-media thickness in children with 
refractory nephrotic syndrome: a randomized controlled trial. Pediatr Nephrol. 2018 
Dec;33(12):2299-2309. doi: 10.1007/s00467-018-4036-x. Epub 2018 Aug 8. PMID: 30091061. 
KDIGO, 2021. Kdigo Clinical Practice Guideline on Glomerular Diseases. 
Kwiterovich, P.O., Jr., 2008. Recognition and Management of dyslipidemia in children and 
adolescents. Journal of clinical endocrinology and metabolism, 93(11), 4200-9. 
Merouni, A, Levy, E, Mongeace, JG. " Hyperlipidemic profiles during remission in childhood 
idiopathic nephrotic syndrome". Clinical Biochemistry. 2003; 36(7):571-4. 
https://doi.org/10.1016/S0009-9120(03)00103-6 
Morofuji Y, Nakagawa S, Ujifuku K, Fujimoto T, Otsuka K, Niwa M, Tsutsumi K. Beyond 
Lipid-Lowering: Effects of Statins on Cardiovascular and Cerebrovascular Diseases and Cancer. 
Pharmaceuticals (Basel). 2022 Jan 26;15(2):151. doi: 10.3390/ph15020151. PMID: 35215263; 
PMCID: PMC8877351. 
Nishi S, Ubara Y, Utsunomiya Y, Okada K, Obata Y, Kai H, Kiyomoto H, Goto S, Konta T, 
Sasatomi Y, Sato Y, Nishino T, Tsuruya K, Furuichi K, Hoshino J, Watanabe Y, Kimura K, 
Matsuo S. Evidence-based clinical practice guidelines for nephrotic syndrome 2014. Clin 
Exp Nephrol. 2016 Jun;20(3):342-70. doi: 10.1007/s10157-015-1216-x. PMID: 27099136; 
PMCID: PMC4891386. 
Prescott, W.A.J., Streetman, D.D. & Streetman, D.S., 2004. The potential role of HMG-CoA 
reductase inhibitors in pediatric nephrotic syndrome. The Annals of pharmacotherapy, 38(12), 
2105–2114. 

 
 
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Querfeld, U. "Should hyperlipidemia in children with nephrotic syndrome be treated?" Pediatric 
Nephrology. 1999; 13(1): 77-84. https://doi.org/10.1007/s004670050568 PMid:1010029  
Su X, Zhang L, Lv J, Wang J, Hou W, Xie X, Zhang H (June 2016). "Effect of Statins on Kidney 
Disease Outcomes: A Systematic Review and Meta-analysis". American Journal of Kidney 
Diseases. 67 (6): 881-892. doi:10.1053/j.ajkd.2016.01.016. PMID26905361 
SM Shamsul Hoque et al: Comparison of Lipid Profile in Different Types of Steroid Sensitive 
Idiopathic Relapsing Nephrotic Syndrome in Children during Active Disease and 
Remission.https://doi.org/10.3329/medtoday.v34i2.6142412. 
Vaziri, N.D. Disorders of lipid metabolism in nephrotic syndrome: Mechanisms and 
consequences. Kidney Int. 2016, 90, 41–52. 
Vinereanu D. Risk factors for atherosclerotic disease: present and future. Herz. 2006 Dec;31 
Suppl 3:5-24. PMID: 17577934.. 
Warady BA, Abraham AG, Schwartz GJ, Wong CS, Munoz A, Betoko A, Mitsnefes M, Kaskel 
F, Greenbaum LA, Mak RH, Flynn J, Moxey-Mims MM, Furth S (2015) Predictors of rapid 
progression of glomerular and nonglomerular kidney disease in children and adolescents:  the 
Chronic Kidney Disease in Children (CKiD) cohort. Am J Kidney Dis 65:878–888 
World Health Organization (2021). World Health Organization model list of essential medicines: 
22nd list (2021). Geneva: World Health Organization. hdl:10665/345533. 
WHO/MHP/HPS/EML/2021.02. 
Yap, Hui-Kim & Teo, Sharon & Ng, Kok. (2021). Pediatric Nephrology On-The-Go. 
10.1142/12531. 
 
 
 
 
 
 
 

 
 
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                                              APPENDIX - I 
TIMETABLE 
(Activities with time schedule) 
 
 
Topic selection:  
July 2023 
Literature search: 
Before and all through the study period 
Protocol writing: 
August 2023 
Approval of the protocol: 
 
December 2023 
Data collection:  
December 2023 to August 2025 
Data processing and analysis &Thesis 
writing:  
 
September 2025 
 
 
 
 
 
 

 
 
18 
APPENDIX –II 
 
The investigations required in this study are directly related to the management of these patients. 
So the investigation cost will be borne by the patient or his/her relatives. The expenditure for the 
study is solely for operational expenses, which is as follows: 
 
Items Cost per patients (Taka)
 
 
 
Total number of patients 
Total cost (Taka) 
CBC 
40 
10000 
RBS 
40 
10000 
S. creatinine 
40 
10000 
Urine R/M/E 
40 
10000 
Urine C/S 
40 
10000 
S. Albumin 
40 
10000 
S. Fasting Lipid Profile 
40 
80000 
Urine spot protein creatinine 
ratio/ 24 hoursUrinary total 
protein 
40 
20000 
Chest x-ray 
40 
10000 
SGPT 
40 
10000 
CPK MB 
40 
60000 
Literature review through 
internet 
 
5000 
Printing, binding 
 
20000 
Miscellaneous 
 
15000 
 
Total cost: Taka 2,80,000/= 
 
 
 
 

 
 
19 
DATA COLLECTION SHEET 
Title:Atorvastatin therapy in the treatment of dyslipidemia 
in children with Steroid Sensitive Nephrotic Syndrome 
 
Serial No:                            Hospital Reg.No:                              Hospital Name: 
 
Researcher: 
Dr Saieef Zaman 
MD (Pediatric Nephrology) Phase B 
Dept. Of Pediatric Nephrology 
National Institute of Kidney disease & Urology 
Phone : 01766400573 
 
Date of admission/outdoor visit       …………… 
 
Date of enrollment:   ............... 
 
Address: …………. 
 
Telephone/Mobile No………… 
 
Socio demographic data:   
1. Name: 
 
2. Age  : 
3. Sex   : 1=Male,     2=Female                                                                        
4. Father’s name: 
5. Mother’s name: 
6. Legal guardian’s name: 
7. Residence: 
             1=Rural, 2= Urban 2 
 
8. Religion:  
            1= Islam, 2= Hindu, 3= Christian, 4= Others                       
 
9. Fathers occupation:  
 1= Farmer, 2= Business, 3= Service ,4= Day laborer, 5= Others 
10.  Mothers occupation:  
                1= Housewife, 2= Business, 3= Service ,4= Day laborer, 5= Others 
11. Socioeconomic status (monthly income in taka):  
             1=Low, 2=Lower middle , 3=Upper  Middle, 4= High 
12. Level of education (Father): 
1=Primary, 2=High school, 3= College & University, 4= No education           
        13)Level of education (Mother): 
             1=Primary, 2=High school, 3= College & University, 4= No education         
         
        

 
 
20 
       14)Immunization: Immunized as per EPI Schedule (1)   Not immunized (2)            
       15)Age of onset of nephrotic syndrome:     
       16)Clinical diagnosis: 
           1= infrequent relapse, 2= frequent relapse 3=steroid dependent                                                           
       17)Treatment with corticosteroid/other immunosuppressant:     
         1=corticosteroid,2=mycophenolatemofetil,3=tacrolimus 4=Cyclosporin, 5=others       
 
       18)History of Cardiovascular disease in family: 
 
       19)  Date of starting treatment:  
Dietary Advice: 
Diet Advice + Atorvastatin therapy: 
 
       20) Demographic variable of patient: 
 
Baseline and clinical characteristics 
Gender: Male/ Female : 
Age : 
Rural/Urban: 
 
21) Clinical variable: 
Date 
 
 
Weight 
 
 
Height 
 
 
BMI 
 
 
Temperature 
 
 
Pulse 
 
 
Blood Pressure 
 
 
Respiratory rate and chest findings   
 
 
Bed Side Urine Albumin 
 
 
Oedema 
 
 
Ascites 
 
 
Others:(Hepatomegaly, Muscle Pain) 
 
 

 
 
21 
22) Laboratory variable: 
Date 
 
 
CBC 
Hb%  
ESR 
TLC 
   N 
   L 
   M 
   E 
Platelet 
 
 
 
CRP 
 
 
S. creatinine 
 
 
Urine R/M/E 
Albumin 
RBC 
Pus cell 
 
 
Urine  Culture   
 
 
Chest X ray  
 
 
Spot Urinary PCR 
 
 
S. Albumin 
 
 
S. 
Fasting 
Lipid 
Profile 
Total cholesterol 
TG 
LDL 
HDL 
 
 
SGPT 
 
 
S.CK MB 
 
 
RBS 
 
 
 
 
Dr Saieef Zaman 
MD (Pediatric Nephrology) Phase B 
Dept. Of Pediatric Nephrology 
National Institute of Kidney disease & Urology 
Phone : 01766400573 

 
 
22 
 
Follow Up Sheet 
 
A. Clinical F/UP 
 
Clinical variable 
1 month 
3 month 
6 month 
Weight 
 
 
 
Height 
 
 
 
BMI 
 
 
 
Temperature 
 
 
 
Pulse 
 
 
 
Blood Pressure 
 
 
 
Respiratory rate and chest 
findings   
 
 
 
BSUA  
 
 
 
Oedema 
 
 
 
Ascites 
 
 
 
Others (Hepatomegaly,Muscle 
pain etc) 
 
 
 
Date & signature 
 
 
 
 
 
 
 
Dr Saieef Zaman 
MD (Pediatric Nephrology) Phase B 
Dept. Of Pediatric Nephrology 
National Institute of Kidney disease & Urology 
Phone : 01766400573 
 
 
 
 
 

 
 
23 
 
B,    Laboratory F/UP 
Laboratory variable 
1 month 
3 month 
6 month 
CBC 
Hb%  
ESR 
TLC 
N 
L 
M 
E 
Platelet 
 
 
 
 
CRP 
 
 
 
S. Creatinine 
 
 
 
Urine R/M/E 
Albumin 
RBC 
Pus cell  
 
 
 
Urine culture 
 
 
 
Chest X ray 
 
 
 
Spot Urinary PCR 
 
 
 
S. Albumin 
 
 
 
S.Fasting 
Lipid Profile 
T.Cholesterol TG 
 
 
 
 
 
 
LDL 
HDL 
 
 
 
 
 
 
SGPT. 
 
 
 
S CK MB 
 
 
 
RBS 
 
 
 
Date & Signature 
 
 
 
 
 
Dr Saieef Zaman 
MD (Pediatric Nephrology) Phase B 
Dept. Of Pediatric Nephrology 
National Institute of Kidney disease & Urology 
Phone : 01766400573 

 
 
24 
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Investigator: Dr. Saieef Zaman                                      Phone: 01766400573                        
 
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n‡”Q GB †ivMx ¸‡jvii‡³ mvaviYZ †Kv‡j÷ij (Pwe©i) cwigvY †ekx _v‡K| GB †Kv‡j‡÷ij Gi evowZ 
cwigvY `xN©w`b a‡i _vK‡j GBme †ivMxi kix‡i wewfbœ ai‡bi RwUjZv †hgb: i³bvjx miæ ev eÜ n‡q 
hvq, i³ PjvP‡j evav m„wó nq Ges cieZ©x‡Z ü`‡iv‡Mi SzuwK e„w× K‡i| `xN©w`b kix‡i †Kv‡j÷ij 
(Pwe©i) cwigvY †ekx _v‡K‡j  `xN© †gqv`x  wKWbx †iv‡Mi SzuwK e„w× K‡i| 
D‡Ïk¨ jÿ¨ :  
GB M‡elYvi D‡Ïk¨ n‡”Q, †b‡d«vwUK wmb‡Wªvg Gi Rb¨ Avcbvi ev”Pvi kix‡i †h †Kv‡j‡÷ij (Pwe©i) 
Gi gvÎv e„w× †c‡q‡Q wKbv, †mUv wK `xN©w`b Av‡Q wKbv Ges †mUvi wPwKrmv Kiv| Ges Zvi Rb¨ 
Avgiv wKQz cixÿv Kie| †mwU AviI †Kvb RwUjZv ‰Zwi K‡i‡Q wKbv Zv Rvb‡Z cvi‡ev| M‡elbvwU 
wkï †b‡dªvjwR wefv‡Mi D‡`¨v‡M cwiPvwjZ| Avcbvi ev”Pv‡K hw` GB M‡elbvq AskMÖnb Kiv‡Z 
m¤§Z _v‡Kb Zvn‡j Avwg Avcbvi wkïi †ivMm¤ú‡Ü wKQz Z_¨ wbe| 
M‡elbvi SzwK:  
GB M‡elbvq Ask MÖn‡b ev”Pv‡`i SzwKi m¤¢vebv bvB|  
M‡elbvi Ask MÖÖn‡bi myweavw`:  
GB M‡elbvq Ask MÖnb Ki‡j Avcbvi ev”Pv wPwKrmv †ÿ‡Î jvfevb n‡Z cvi‡e| wKWbxi GB `xN© 
†gqv`x Amy‡Li Kvi‡Y Avcbvi ev”Pvi kix‡i †Kv‡j÷ij Gi cwigvY gvÎvwZwi³ e„w× †c‡q‡Q wKbv,Zv 
`xN©¯’qx Av‡Q wKbv Ges †mUvi wPwKrmv cv‡eb| Ges GB mgm¨vi Kvi‡b Ab¨vb¨ †h mgm¨v¸‡jv n‡Z 
cv‡i †mUvi m¤^‡Ü Avcwb AeMZ n‡eb|  Avi cÖv_wgK ch©v‡q GwU Rvbv m¤¢e n‡j Avcbvi ev”Pvi 
Rb¨ cieZ©x‡Z wK e¨e¯’v wb‡Z n‡e Zv Avcbv‡K Rvwb‡q w`e|  
weKí:  
GB M‡elbvq Ask MÖnb Kiv wKsev bv Kiv‡Z Avcbvi ev”Pvi †b‡d«vwUK wmb‡Wªvg Gi wPwKrmvi 
†Kvb ZviZg¨ n‡e bv| Ask MÖnb Kivi ci †h †Kvb mgq Avcbx Avcbvi ev”Pv‡K M‡elbv †_‡K mwi‡q 
wb‡Z cvi‡eb| 

 
 
25 
LiP:  
GB M‡elbvq Ask MÖn‡bi Rb¨ Avcbvi evowZ †Kvb LiP †bB| 
 
 
‡MvcbxqZv:  
M‡elbv PjvKvjxb I cieZx©‡Z mgq Z_¨ K‡Vvi fv‡e †Mvcb Kiv n‡e| Avcbvi ev”Pvi Rb¨ GK M‡elbv 
PjvKvjxb I cieZx©‡Z mgq Z_¨ K‡Vvi fv‡e †Mvcb Kiv n‡e| Avcbvi ev”Pvi Rb¨ GKwU AvBwW †`Iqv 
n‡e| Avcbvi AvBwW b¤^i m¤^wjZ me ai‡bi KvMR cÎ Avcbvi bvg, wVKvbv ewm‡q Awd‡mi dvBwjs 
†Kwe‡b‡U Zvjve× _vK‡e| e¨w³MZ welqvw` Z_¨ we‡køl‡b, cÖwZ‡e`b •Zix cÖKvkbvi Kv‡R e¨envi Kiv 
n‡e Ges M‡elbvi cixÿK e¨ZxZ Kv‡iv Kv‡Q cÖKvk Kiv n‡e bv| d‡j Avcbvi Z_¨ †KD Rvb‡Z cvi‡e bv|  
 
‡¯^”Qv g~jK Ask MÖnb:  
GB M‡elbvq Avcbvi ev”PviAsk MÖnb m¤ú~Y© †¯^”Qvg~jK| Avcwb M‡elbvq Ask MÖn‡b 
A¯^xK…wZ Rvbv‡Z cv‡ib A_ev M‡elbv PjvKvjxb †h †Kvb mgq M‡elbv †_‡K Avcbvi ev”Pv‡K 
cÖZ¨vnvi K‡i wb‡Z cv‡ib| Zv‡Z Avcbvi wPwKrmvi ZviZg¨ n‡ebv| GB di‡g ¯^vÿi Ki‡j Avcbvi ev”Pvi 
AvBbMZ †Kvb AwaKvi Le© n‡e bv| 
mgqt 
GB M‡elbvq Avcbvi 6 মমম মমম মমমমম মমম ম মমমমমম  মমমমমমমমমম মম, মমম 1, 3 মম   মমম মম মমমমম  
মমমম মমমম 
cÖkœvejxt  
hw` Avcbvi †Kvb cÖkœ _v‡K Z‡e `qv K‡i wRÁvmv Ki‡eb| Avwg Avcbvi DËi cÖ`vb Kivi h_vmva¨ 
†Póv Ki‡ev| hw` fwel¨‡Z Avcbvi ‡Kvb মমমমমমমম D‡`«K  nq  Zvn‡j  M‡elYviZ  মমম মমমম মমমমম, 
মমমম মমমমম wefvM, মমমমম- 628, মমমমমমমম  মমমমমমমমমম মম মমমমম মমমমমমম 
মমমম মমমমমমম ম‡hvMv‡hvM Ki‡Z cvi‡eb মAvgvi ‡gvevBj bv¤^vi nj  01766400573ম 
m¤§wZ ¯^xKv‡ivw³t 
Avwg M‡elYvq wb‡qvwRZ wPwKrm‡Ki mv‡_ (whwb Avgvi ev”Pvi kvixwiK cixÿv Ki‡eb) GB 
M‡elYv wb‡q Av‡jvPbvq mš‘wó cÖKvk KiwQ| Avwg GUv ey‡SwQ †h, M‡elYvq Ask MÖnY †¯^”Qv 
g~jK Ges Avwg †h †Kvb mgq †Kvb eva¨evaKZv QvovB M‡elYv †_‡K Avgvi ev”Pv‡K weiZ ivL‡Z 
cvwi| Avwg Dc‡iv³ welq¸‡jv c‡owQ / Avgvi m¤§‡L cwVZ n‡q‡Q Ges †¯^”Qvq M‡elYvq Ask MÖnY 
Ki‡Z m¤§wZÁvcb KiwQ| 
 
M‡el‡Ki ¯^vÿi t  
 
 
 
 
 
 
 
ZvwiLt  
bvgt  
 
Ask MÖnbKvixi ¯^vÿit  
 
 
 
 
 
ZvwiLt  
bvgt  
 

 
 
26 
Awffve‡Ki ¯^vÿi/e„×v½ywji Qvct  
 
 
 
 
 
ZvwiLt 
bvgt  
 
মমমমমমম মমমমমমমম                                                          ZvwiLt 
bvgt  
 
AewnZ m¤§wZcÎ/Assent Form 
Atorvastatin therapy in the treatment of dyslipidemia in children with  
Steroid Sensitive Nephrotic Syndrome 
 
Investigator: Dr. Saieef Zaman                                      Phone: 01766400573                        
 
GB m¤§wZc‡Îi D‡Ïk¨ nj Avcbv‡K cÖ‡qvRbxq Z_¨ cÖ`vbKiv, †h Z_¨¸‡jv Avcbv‡K wm×všÍ 
wb‡Z mvnvh¨ Ki‡e, Avcwb GB M‡elYvq AskMªnb Ki‡eb wKbv? 
 
M‡el‡Ki cwiwPwZt 
 
Avwg Wvt mvCd Rvgvb, b¨vkbvj Bbw÷wUDUAe wKWwb wWwR‡RR GÛ BD‡ivjwR‡Z wkï wKWbx 
wefv‡Mi Gg.wW ‡iwm‡WwÝ, ‡dBR-we Gi wPwKrmK wn‡m‡e Kg©iZ AvwQ| Avwg wkï 
‡b‡d«vwUK wmb‡W«vg ‡iv‡Mi Kvi‡Y i‡³ ‡Kv‡j‡÷‡iji cwigvY ‡ewk _vK‡j, Zvi wPwKrmvi Dci 
M‡elYv KiwQ| Avwg Avcbv‡K GB m¤ú‡K©  c«‡qvRbxq Z_¨ c«`vb K‡i GB  M‡elYvq AskM«n‡bi 
Avn&evb KiwQ| 
 
f~wgKv: 
‡b‡d«vwUK wmb‡Wªvg wKWbxi GKwU wbivgq †hvM¨ †ivM|GB †iv‡Mi GKwU Ab¨Zg RwUjZv 
n‡”Q GB †ivMx ¸‡jvii‡³ mvaviYZ †Kv‡j÷ij (Pwe©i) cwigvY †ekx _v‡K| GB †Kv‡j‡÷ij Gi evowZ 
cwigvY `xN©w`b a‡i _vK‡j GBme †ivMxi kix‡i wewfbœ ai‡bi RwUjZv †hgb: i³bvjx miæ ev eÜ n‡q 
hvq, i³ PjvP‡j evav m„wó nq Ges cieZ©x‡Z ü`‡iv‡Mi SzuwK e„w× K‡i| `xN©w`b kix‡i †Kv‡j÷ij 
(Pwe©i) cwigvY †ekx _v‡K‡j  `xN© †gqv`x  wKWbx †iv‡Mi SzuwK e„w× K‡i| 
D‡Ïk¨ jÿ¨ :  
GB M‡elYvi D‡Ïk¨ n‡”Q, †b‡d«vwUK wmb‡Wªvg Gi Rb¨ Avcbvi  kix‡i †h †Kv‡j‡÷ij (Pwe©i) Gi gvÎv 
e„w× †c‡q‡Q wKbv, †mUv wK `xN©w`b Av‡Q wKbv Ges †mUvi wPwKrmv Kiv| Ges Zvi Rb¨ Avgiv 
wKQz cixÿv Kie| †mwU AviI †Kvb RwUjZv ‰Zwi K‡i‡Q wKbv Zv Rvb‡Z cvi‡ev| M‡elbvwU wkï 
†b‡dªvjwR wefv‡Mi D‡`¨v‡M cwiPvwjZ|মমমম hw` GB M‡elbvq AskMÖnb Kiv‡Z m¤§Z _v‡Kb Zvn‡j 
Avwg Avcbvi  †ivMm¤ú‡Ü wKQz Z_¨ wbe| 
M‡elbvi SzwK:  
GB M‡elbvq Ask MÖn‡b ev”Pv‡`i SzwKi m¤¢vebv bvB|  
M‡elbvi Ask MÖÖn‡bi myweavw`:  

 
 
27 
GB M‡elbvq Ask MÖnb Ki‡j Avcbvi  wPwKrmv †ÿ‡Î jvfevb n‡Z cvi‡e| wKWbxi GB `xN© †gqv`x 
Amy‡Li Kvi‡Y Avcbvi  kix‡i †Kv‡j÷ij Gi cwigvY gvÎvwZwi³ e„w× †c‡q‡Q wKbv,Zv `xN©¯’qx Av‡Q 
wKbv Ges †mUvi wPwKrmv cv‡eb| Ges GB mgm¨vi Kvi‡b Ab¨vb¨ †h mgm¨v¸‡jv n‡Z cv‡i †mUvi 
m¤^‡Ü Avcwb AeMZ n‡eb|  Avi cÖv_wgK ch©v‡q GwU Rvbv m¤¢e n‡j Avcbvi  Rb¨ cieZ©x‡Z wK 
e¨e¯’v wb‡Z n‡e Zv Avcbv‡K Rvwb‡q w`e|  
weKí:  
GB M‡elbvq Ask MÖnb Kiv wKsev bv Kiv‡Z Avcbvi †b‡d«vwUK wmb‡Wªvg Gi wPwKrmvi †Kvb 
ZviZg¨ n‡e bv| Ask MÖnb Kivi ci †h †Kvb mgq Avcbx  M‡elbv †_‡K mwi‡q wb‡Z cvi‡eb| 
LiP:  
GB M‡elbvq Ask MÖn‡bi Rb¨ Avcbvi evowZ †Kvb LiP †bB| 
                                          
 
‡MvcbxqZv:  
M‡elbv PjvKvjxb I cieZx©‡Z mgq Z_¨ K‡Vvi fv‡e †Mvcb Kiv n‡e| Avcbvi  Rb¨ GK M‡elbv PjvKvjxb I 
cieZx©‡Z mgq Z_¨ K‡Vvi fv‡e †Mvcb Kiv n‡e| Avcbvi  Rb¨ GKwU AvBwW †`Iqv n‡e| Avcbvi 
AvBwW b¤^i m¤^wjZ me ai‡bi KvMR cÎ Avcbvi bvg, wVKvbv ewm‡q Awd‡mi dvBwjs †Kwe‡b‡U 
Zvjve× _vK‡e| e¨w³MZ welqvw` Z_¨ we‡køl‡b, cÖwZ‡e`b •Zix cÖKvkbvi Kv‡R e¨envi Kiv n‡e Ges 
M‡elbvi cixÿK e¨ZxZ Kv‡iv Kv‡Q cÖKvk Kiv n‡e bv| d‡j Avcbvi Z_¨ †KD Rvb‡Z cvi‡e bv|  
 
‡¯^”Qv g~jK Ask MÖnb:  
GB M‡elbvq Avcbvi Ask MÖnb m¤ú~Y© †¯^”Qvg~jK| Avcwb M‡elbvq Ask MÖn‡b A¯^xK…wZ 
Rvbv‡Z cv‡ib A_ev M‡elbv PjvKvjxb †h †Kvb mgq M‡elbv †_‡K মমমম cÖZ¨vnvi K‡i wb‡Z cv‡ib| 
Zv‡Z Avcbvi wPwKrmvi ZviZg¨ n‡ebv| GB di‡g ¯^vÿi Ki‡j Avcbvi AvBbMZ †Kvb AwaKvi Le© n‡e 
bv| 
mgqt 
GB M‡elbvq Avcbvi 6 মমম মমম মমমমম মমম ম মমমমমমমমমম মম, মমম 1, 3 মম   মমম মম মমমমম  
মমমম মমমম 
cÖkœvejxt  
hw` Avcbvi †Kvb cÖkœ _v‡K Z‡e `qv K‡i wRÁvmv Ki‡eb| Avwg Avcbvi DËi cÖ`vb Kivi h_vmva¨ 
†Póv Ki‡ev| hw` fwel¨‡Z Avcbvi ‡Kvb মমমমমমমম D‡`«K  nq  Zvn‡j  M‡elYviZ  মমম মমমম মমমমম, 
মমমম মমমমম wefvM, মমমমম- 628, মমমমমমমম   মমমমমমমমমম মম মমমমম মমমমমমম 
মমমম মমমমমমম ম‡hvMv‡hvM Ki‡Z cvi‡eb মAvgvi ‡gvevBj bv¤^vi nj  01766400573ম 
m¤§wZ ¯^xKv‡ivw³t 
Avwg M‡elYvq wb‡qvwRZ wPwKrm‡Ki mv‡_ (whwb Avgvi  kvixwiK cixÿv Ki‡eb) GB M‡elYv 
wb‡q Av‡jvPbvq mš‘wó cÖKvk KiwQ| Avwg GUv ey‡SwQ †h, M‡elYvq Ask MÖnY †¯^”Qv g~jK 
Ges Avwg †h †Kvb mgq †Kvb eva¨evaKZv QvovB M‡elYv †_‡K weiZ ivL‡Z cvwi| Avwg Dc‡iv³ 
welq¸‡jv c‡owQ / Avgvi m¤§‡L cwVZ n‡q‡Q Ges †¯^”Qvq M‡elYvq Ask MÖnY Ki‡Z m¤§wZÁvcb 
KiwQ| 
 

 
 
28 
 
M‡el‡Ki ¯^vÿi t  
 
 
 
 
 
 
 
ZvwiLt  
bvgt  
 
Ask MÖnbKvixi ¯^vÿit  
 
 
 
 
 
ZvwiLt  
bvgt  
 
 
মমমমমমম মমমমমমমম                                                          ZvwiLt 
bvgt  
 
 
 
                                          INFORMED CONSENT FORM IN ENGLISH 
TITLE: Atorvastatin therapy in the treatment of dyslipidemia in children with Steroid 
Sensitive Nephrotic Syndrome 
Investigator:Dr Saieef Zaman                                                              Phn no: 01766400573 
ID no. of the participant: 
The aim of this consent form is to give you the information that will help you to make decision 
whether you will participate in research.  
About the Researcher:  
I am Dr.Saieef Zaman, working as a doctor of MD phase B resident in the department of 
Pediatric Nephrology, National Institute of Kidney Diseases and Urology. I am researching on 
topics related to the treatment of dyslipidemia in children with Steroid Sensitive Nephrotic 
Syndrome. I will provide you necessary information and invite you to participate in this study. 
The purpose of this consent form is to give you relevant information which will help you 
whether you will participate in this research or not.   
Introduction:  
Nephrotic syndrome is a curable disease Hypercholesterolemia is one of the complications of 
this disease. For this reason, these children are more susceptible to developing atherosclerosis. 

 
 
29 
Atherosclerosis is one of the major risks for developing cardiovascular diseases. Also, these 
patients may develop glomerulosclerosis ultimately ending in CKD. 
Purpose of the study: 
Aim of the study is to measure the serum Fasting lipid profile in different types of Steroid 
Sensitive Nephrotic Syndrome in Children and manage it either by dietary intervention or by 
dietary intervention and atorvastatin to find out which is better. This study will be held in the 
Pediatric Nephrology/Nephrology Department. If you give your consent to participate in this 
study, then I will take some information about your child.  
Risk of the study: 
There is low risk to participate in this study.  
Advantages in participating in this study:  
Your child will benefit if they participate in this study. We will be able to know whether your 
child is developing increased amounts of lipid in the blood as it is a common side effect of the 
disease and appropriately manage it so no further complications arise from this condition. You 
can withdraw your child at any time from this study.  
 
Alternative:  
The normal treatment of your child shall proceed as per general treatment procedure of the 
hospital, even if your child do not participate in the research.  
Compensation for the study: There is no excess cost in participating in this study. 
Confidentiality: 
In the duration of the study, your information will not be disclosed. We will give an ID to your 
child. Your file containing all information will be secured. Except the researcher and people 
related to research, this information will not be disclosed to others.  
Rights as participants: 
You can actively participate in this study. You can withdraw your child at any time. . If you 
participate in this study this will be fruitful for your child. No rights will be hampered to 
participate in this study. 
Time Period:  
The research will take 6 months of your time. Your child will be followed up at 1, 3 month & 6 
month after participation. 
Questions or problem:  

 
 
30 
You can ask me any question any time during this study. I will try my best to give an answer. In 
future, if any questions arise, please contact me by asking for Dr Saieef Zaman in Room no 628, 
Dept of Pediatric Nephrology, National Institute of Kidney Disease & Urology. My phone no is 
01766400573. 
Informed consent: 
I have been informed regarding this study. I understand that I can actively participate in this 
study and can withdraw my child at any time. All the above things are explained in front of me. I 
give my consent to participate in this study. 
Signature of investigator:                          Date:                Name: 
Signature of guardian:                             Date:                Name: 
Signature (Participant):                            Date:                Name:  
Signature (Witness to consent):                   Date:                Name: 
 
 
                                    INFORMED ASSENT FORM IN ENGLISH 
TITLE: Atorvastatin therapy in the treatment of dyslipidemia in children with Steroid 
Sensitive Nephrotic Syndrome 
Investigator:Dr Saieef Zaman                                                              Phn no: 01766400573 
ID no. of the participant: 
The aim of this assent form is to give you the information that will help you to make decision 
whether you will participate in research.  
About the Researcher:  
I am Dr.Saieef Zaman, working as a doctor of MD phase B resident in the department of 
Pediatric Nephrology, National Institute of Kidney Diseases and Urology. I am researching on 
topics related to the treatment of dyslipidemia in children with Steroid Sensitive Nephrotic 
Syndrome. I will provide you necessary information and invite you to participate in this study. 
The purpose of this assent form is to give you relevant information which will help you whether 
you will participate in this research or not.   
Introduction:  
Nephrotic syndrome is a curable disease Dyslipidaemia is one of the complications of this 
disease. For this reason, these children are more susceptible to developing atherosclerosis. 

 
 
31 
Atherosclerosis is one of the major risks for developing cardiovascular diseases. Also, these 
patients may develop glomerulosclerosis ultimately ending in CKD. 
Purpose of the study: 
Aim of the study is to measure the serum Fasting lipid profile in different types of Steroid 
Sensitive Nephrotic Syndrome in Children and manage it either by dietary intervention or by 
dietary intervention and atorvastatin to find out which is better. This study will be held in the 
Pediatric Nephrology. If you give your consent to participate in this study, then I will take some 
information about you.  
Risk of the study: 
There is low risk to participate in this study.  
Advantages in participating in this study:  
You will benefit if you participate in this study. We will be able to know whether you are 
developing increased amounts of lipid in the blood as it is a common side effect of the disease 
and appropriately manage it so no further complications arise from this condition. You can 
withdraw yourself at any time from this study.  
 
Alternative:  
The normal treatment of yourself shall proceed as per general treatment procedure of the 
hospital, even if you do not participate in the research.  
Compensation for the study: There is no excess cost in participating in this study. 
Confidentiality: 
In the duration of the study, your information will not be disclosed. We will give an ID to you. 
Your file containing all information will be secured. Except the researcher and people related to 
research, this information will not be disclosed to others.  
Rights as participants: 
You can actively participate in this study. You can withdraw yourself at any time. . If you 
participate in this study this will be fruitful for you. No rights will be hampered to participate in 
this study. 
Time Period:  
The research will take 6 months of your time. Your will be followed up at 1,3 month & 6 month 
after participation. 
Questions or problem:  

 
 
32 
You can ask me any question any time during this study. I will try my best to give an answer. In 
future, if any questions arise, please contact me by asking for Dr Saieef Zaman in Room no 628, 
Dept of Pediatric Nephrology, National Institute of Kidney Disease & Urology. My phone no is 
01766400573. 
Informed consent: 
I have been informed regarding this study. I understand that I can actively participate in this 
study and can withdraw myself at any time. All the above things are explained in front of me. I 
give my consent to participate in this study. 
 
Signature of investigator:                          Date:                Name: 
Signature (Participant):                            Date:                Name:  
Signature (Witness to consent):                   Date:                Name: 
 
INFORMED CONSENT FORM FOR SUBJECTS 
Title of research study: Atorvastatin therapy in treatment of dyslipidemia in children with 
Steroid Sensitive Nephrotic Syndrome 
 
Principle investigator:  
Dr. Saieef Zaman 
MD (Paediatric Nephrology) Phase B 
Department Of Pediatric Nephrology 
National Institute of Kidney Disease & Urology 
Phone : 01515682602 
ID no. of the participant:  
 I consent to participate in the research named above, the particulars of which including 
details of data sheet have been explained to me 
 I authorize the researcher to use with me the interviews and to fulfill the data sheet 
acknowledging that:  
1. The possible effects of the interviews and data sheet have been explained to 
me to my satisfaction 
2. I have been informed that I am free to withdraw from the research at any 
time without explanation or prejudice and to withdraw any unprocessed data 
previously supplied 
3. The project is for the purpose of research 

 
 
33 
4. I have been informed that the confidentiality of the information I provide will 
be safeguarded subject to any legal requirements 
5. I have been informed regarding the interviews. I have also been informed 
that because of the number of people to be interviewed in small; it is possible 
that someone may still be able to identify me on the basis of any references 
to personal information that might allow someone to guess my identity. 
However, I will be referred by pseudonym or identified by a different name 
in any publications arising from the research. 
 
 
 
Signature (Participant)  
                                                 Date 
 
Signature (Witness to consent)                        
 
 Date