Clinical trial NCT06327009: Effect of Ramadan Fasting on Kidney Function and Proteinuria in Patients With Glomerulonephritis
Official title: Effect of Ramadan Fasting on Kidney Function and Proteinuria in Patients With Glomerulonephritis: a Prospective Observational Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fasting Ramadan
Keywords: fasting ramadan
glomerulonephritis
kidney functions
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: one hundred patients with biopsy proven glomerulonephritis for more than 3 months from different centers in Egypt will be enrolled in the study

Brief summary: This research aims to assess effects of ramadan fasting on kidney function and proteinuria in patients with glomerulonephritis.

Detailed description: Fasting from sunrise to sunset during the Islamic holy month of Ramadan is one of the five pillars of the Islamic faith. Duration of the fasting ranges from 10 to 18 hours per day according to the geographic location and the season. Although people with chronic illnesses are exempted from fasting according to Islamic beliefs, many patients insist on fasting against medical advice. Through the last three decades many reports studied the potential risks and benefits of fasting Ramadan in regular hemodialysis (HD) patients. Target points of investigation were different. Most of them were focusing on the electrolytes and nutritional changes. Fewer reports tested the mortality rate. In a multicenter observational study, 2055 Egyptian patients from 25 HD units were studied for frequency of fasting in Ramadan and the possible effect of fasting on clinical and biochemical variables. The investigators concluded that nearly 47% of the study patients fasted at least few days of Ramadan. They recommended that HD patients should be encouraged to discuss the option of fasting in Ramadan with their HD staff who might be able to give advice on whether to allow them to fast in days off dialysis with special precautions regarding associated comorbidities, especially diabetes and coronary artery disease. Most of the studies focused on the effects of fasting the month of Ramadan in CKD and hemodialysis patients, but no research assessed these effects specifically in patients with glomerulonephritis.

Eligibility criteria: Inclusion Criteria:

* Patients with biopsy proven glomerulonephritis with eGFR ≥ 30 ml/min for more than 3 months (exception is nephrotic patients with positive anti-PLA2R indicative of primary membranous).

Exclusion Criteria:

* Patients with medical contraindications for fasting.
* Patients with eGFR \< 30 ml/min.
* Patients with acute cardiovascular disease.
* uncontrolled diabetes mellitus.
* active or chronic inflammatory disease.
* Acute liver disease.
* Pregnancy.

Primary outcomes:
measure: Change in kidney function
timeFrame: 4 weeks (month of ramadan)
measure: Change in proteinuria
timeFrame: 4 weeks (month of ramadan)
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, Aexandria University
Study officials:
affiliation: assistant professor
name: Mohamed Mamdouh Elsayed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: lecturer
name: kariem M salem, MD
role: STUDY_CHAIR
References:
citation: Sahin SB, Ayaz T, Ozyurt N, Ilkkilic K, Kirvar A, Sezgin H. The impact of fasting during Ramadan on the glycemic control of patients with type 2 diabetes mellitus. Exp Clin Endocrinol Diabetes. 2013 Oct;121(9):531-4. doi: 10.1055/s-0033-1347247. Epub 2013 Aug 9.
citation: Megahed AF, El-Kannishy G, Sayed-Ahmed N. Status of fasting in Ramadan of chronic hemodialysis patients all over Egypt: A multicenter observational study. Saudi J Kidney Dis Transpl. 2019 Mar-Apr;30(2):339-349. doi: 10.4103/1319-2442.256841.