NCT02786823

Effect of Folic Acid and Vitamin B12 Supplementation in Subjects With Type 2 Diabetes

Effect of Folic Acid and Vitamin B12 Supplementation on Biochemical Parameters in Subjects With Type-2 Diabetes

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: All India Institute of Medical Sciences, Bhubaneswar · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Folic acid	tab. Folic acid 5 mg
DIETARY_SUPPLEMENT	Vitamin B12	tab. Vitamin B12 500 mcg
DRUG	Oral hypoglycemic agents [Metformin +/- Sulfonylurea]	Patients receiving either of the following oral hypoglycemic agents 1. Sulfonylurea 2. Metformin 3. Metformin plus Sulfonylurea

Timeline

• Start date: 2017-05-01
• Primary completion: 2017-08-15
• Completion: 2017-09-15
• First posted: 2016-06-01
• Last updated: 2017-09-19

Locations

1 site across 1 country: India