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

• Status: Completed
• Trial end date: 2017-09-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar
• Treatments: Folic Acid; Hydroxocobalamin; Hypoglycemic Agents; Metformin; Vitamin B 12; Vitamin B Complex; Vitamins

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.