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

September 18, 2017 updated by: Dr. Debapriya Bandyopadhyay, All India Institute of Medical Sciences, Bhubaneswar

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Odisha
      • Bhubaneswar, Odisha, India, 751019
        • All India Institute of Medical Sciences, Bhubaneswar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Folic acid
Twenty type-2 diabetes patients with standard Oral hypoglycemic agents [Metformin +/- Sulfonylurea] will be recruited and additionally receive tab. Folic acid 5 mg once daily for 8 weeks
Dietary supplement: Folic acid
tab. Folic acid 5 mg
Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]

Patients receiving either of the following oral hypoglycemic agents

  1. Sulfonylurea
  2. Metformin
  3. Metformin plus Sulfonylurea
Other Names:
  • Metformin, Sulfonylurea
Experimental: Vitamin B12
Twenty type-2 diabetes patients with standard Oral hypoglycemic agents [Metformin +/- Sulfonylurea] will be recruited and additionally receive tab. Vitamin B12 500 mcg once daily for 8 weeks
Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]

Patients receiving either of the following oral hypoglycemic agents

  1. Sulfonylurea
  2. Metformin
  3. Metformin plus Sulfonylurea
Other Names:
  • Metformin, Sulfonylurea
Dietary supplement: Vitamin B12
tab. Vitamin B12 500 mcg
Experimental: "Folic acid" and "Vitamin B12"
Twenty type-2 diabetes patients with standard Oral hypoglycemic agents [Metformin +/- Sulfonylurea] will be recruited and additionally receive both tab. Folic acid 5 mg once daily and tab. Vitamin B12 500 mcg once daily for 8 weeks
Dietary supplement: Folic acid
tab. Folic acid 5 mg
Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]

Patients receiving either of the following oral hypoglycemic agents

  1. Sulfonylurea
  2. Metformin
  3. Metformin plus Sulfonylurea
Other Names:
  • Metformin, Sulfonylurea
Dietary supplement: Vitamin B12
tab. Vitamin B12 500 mcg
Active Comparator: Control
Twenty type-2 diabetes patients with standard Oral hypoglycemic agents [Metformin +/- Sulfonylurea] will be recruited and receive no additional supplementation
Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]

Patients receiving either of the following oral hypoglycemic agents

  1. Sulfonylurea
  2. Metformin
  3. Metformin plus Sulfonylurea
Other Names:
  • Metformin, Sulfonylurea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting plasma glucose
Time Frame: 8 weeks
8 weeks
Fasting plasma insulin
Time Frame: 8 weeks
8 weeks
Insulin Resistance
Time Frame: 8 weeks
Using Homeostatic model assessment (HOMA2 calculator which uses fasting plasma glucose and plasma insulin values to calculate insulin resistance)
8 weeks
Serum total cholesterol
Time Frame: 8 weeks
8 weeks
Serum triacylglycerol
Time Frame: 8 weeks
8 weeks
Serum Low-density lipoprotein (LDL)
Time Frame: 8 weeks
8 weeks
Serum High-density lipoprotein (HDL)
Time Frame: 8 weeks
8 weeks
Serum Very Low-density lipoprotein (VLDL)
Time Frame: 8 weeks
8 weeks
Serum Homocysteine
Time Frame: 8 weeks
8 weeks
Serum Adiponectin
Time Frame: 8 weeks
8 weeks
Serum Tumor Necrosis Factor (TNF)
Time Frame: 8 weeks
8 weeks
Serum Interleukin-6 (IL-6)
Time Frame: 8 weeks
8 weeks
Serum C reactive protein (CRP)
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, Bhubaneswar

Investigators

  • Principal Investigator: Debapriya Bandyopadhyay, M.D., All India Institute of Medical Sciences, Bhubaneswar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

August 15, 2017

Study Completion (Actual)

September 15, 2017

Study Registration Dates

First Submitted

May 25, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimate)

June 1, 2016

Study Record Updates

Last Update Posted (Actual)

September 19, 2017

Last Update Submitted That Met QC Criteria

September 18, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T/lM-F/Biochem/15/22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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