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

NCT02786823 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-09-19

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

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

Sponsors & Collaborators

  • All India Institute of Medical Sciences, Bhubaneswar

    lead OTHER

Principal Investigators

  • Debapriya Bandyopadhyay, M.D. · All India Institute of Medical Sciences, Bhubaneswar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2017-08-15
Completion
2017-09-15

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02786823 on ClinicalTrials.gov