Clinical trial NCT02786823: Effect of Folic Acid and Vitamin B12 Supplementation in Subjects With Type 2 Diabetes
Official title: Effect of Folic Acid and Vitamin B12 Supplementation on Biochemical Parameters in Subjects With Type-2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: All India Institute of Medical Sciences, Bhubaneswar
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effect of Folic acid and Vitamin B12 supplementation on Biochemical parameters in subjects with type-2 Diabetes. 80 selected subjects will be divided into 4 groups of 20 each.

* Group A: to receive Folic acid 5 mg once daily for 8 weeks along with standard oral anti-diabetic drugs;
* Group B: to receive Vitamin B12 500 mcg once daily for 8 weeks along with standard oral anti-diabetic drugs;
* Group C: to receive both Folic acid 5 mg once daily and Vitamin B12 500 mcg once daily for 8 weeks along with standard oral anti-diabetic drugs;
* Group D: to receive no additional intervention apart from standard oral anti-diabetic drugs.

The biochemical parameters will be evaluated before and after the intervention.

Detailed description: This is a randomized, parallel group, open label study to evaluate the effect of Folic acid and Vitamin B12 supplementation on Biochemical parameters in subjects with type-2 Diabetes.

80 selected subjects will be randomly assigned to 4 groups of 20 each as follows:

* Group A: to receive Folic acid 5 mg once daily for 8 weeks along with standard oral anti-diabetic drugs;
* Group B: to receive Vitamin B12 500 mcg once daily for 8 weeks along with standard oral anti-diabetic drugs;
* Group C: to receive both Folic acid 5 mg once daily and Vitamin B12 500 mcg once daily for 8 weeks along with standard oral anti-diabetic drugs;
* Group D: to receive no additional intervention apart from standard oral anti-diabetic drugs.

The subjects will also be advised to be on a normal routine diet, not to skip any meal and not to change their exercise pattern (if any) during the study period.The compliance of the intervention will be monitored by instructing the patients to return all unused tablets at the end of the 8 weeks period of study.

All the subjects will be asked to report after an overnight fasting of 12 hours on two occasions i.e. at the start of the study before allocation of group and 8 weeks after allocation. After measurement of body weight, height and blood pressure (by Mercury Sphygmomanometer), 5 milliliter of early morning fasting venous blood sample will be collected under aseptic measures on both the occasions. The samples collected will then be appropriately processed for the analysis of various biochemical parameters.

The results of all the parameters evaluated will be recorded in the subject's Data Collection Form.The data will be analyzed using Statistical Package for the Social Sciences (SPSS) version 21.

Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetic patients within age group 30-65 years, on stable dose of anti-diabetic with/without anti-hypertensive drugs will be included in this study

Exclusion Criteria:

* Subjects on non-allopathic forms of treatment for diabetic control.
* Subjects with Chronic Renal disease and Liver disease.
* Subjects with malabsorption.
* Subjects with Thyroid function abnormalities.
* HbA1c levels more than 10 %
* Smoking
* Alcoholism
* Pregnant subjects
* Subjects with vitamin B12 deficiency
* Subjects already on Folate or Vitamin B12 supplementation due to some other medical condition
* The detailed drug history of the subjects will be taken prior to including them in the study. Antibiotics like Fluoroquinolones; anti-seizure drugs like phenytoin; Corticosteroids and Hormonal Contraceptives; Hypolipidemic drugs like statins are known to affect Glucose metabolism and subjects on these medications will not be included in the study.

Primary outcomes:
measure: HbA1c
timeFrame: 8 weeks
Secondary outcomes:
measure: Fasting plasma glucose
timeFrame: 8 weeks
measure: Fasting plasma insulin
timeFrame: 8 weeks
measure: Insulin Resistance
timeFrame: 8 weeks
measure: Serum total cholesterol
timeFrame: 8 weeks
measure: Serum triacylglycerol
timeFrame: 8 weeks
measure: Serum Low-density lipoprotein (LDL)
timeFrame: 8 weeks
measure: Serum High-density lipoprotein (HDL)
timeFrame: 8 weeks
measure: Serum Very Low-density lipoprotein (VLDL)
timeFrame: 8 weeks
measure: Serum Homocysteine
timeFrame: 8 weeks
measure: Serum Adiponectin
timeFrame: 8 weeks
measure: Serum Tumor Necrosis Factor (TNF)
timeFrame: 8 weeks
measure: Serum Interleukin-6 (IL-6)
timeFrame: 8 weeks
measure: Serum C reactive protein (CRP)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bhubaneswar
country: India
facility: All India Institute of Medical Sciences, Bhubaneswar
state: Odisha
Study officials:
affiliation: All India Institute of Medical Sciences, Bhubaneswar
name: Debapriya Bandyopadhyay, M.D.
role: PRINCIPAL_INVESTIGATOR
References: