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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: Folic acid; Dietary Supplement: Vitamin B12; Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]

• Registration Number: NCT02786823
• Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar

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.

Study Timeline

• Study First Submitted: 2016-05-25
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-06-01
• Study Start: 2017-05-01
• Primary Completion: 2017-08-15
• Status Verified: 2017-09
• Study Completion: 2017-09-15
• Last Update Submitted: 2017-09-18
• Last Update Posted: 2017-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Folic acid	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
Folic acid	Oral hypoglycemic agents [Metformin +/- Sulfonylurea]	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
Vitamin B12	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
Vitamin B12	Oral hypoglycemic agents [Metformin +/- Sulfonylurea]	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
"Folic acid" and "Vitamin B12"	Folic acid	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
"Folic acid" and "Vitamin B12"	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
"Folic acid" and "Vitamin B12"	Oral hypoglycemic agents [Metformin +/- Sulfonylurea]	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
Control	Oral hypoglycemic agents [Metformin +/- Sulfonylurea]	Twenty type-2 diabetes patients with standard Oral hypoglycemic agents \[Metformin +/- Sulfonylurea\] will be recruited and receive no additional supplementation

Primary Outcome Measures

Name	Time	Method
HbA1c	8 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

All India Institute of Medical Sciences, Bhubaneswar; 🇮🇳 Bhubaneswar, Odisha, India