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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02786823
• Other study ID #: T/lM-F/Biochem/15/22
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 25, 2016
• Last updated: September 18, 2017
• Start date: May 1, 2017
• Est. completion date: September 15, 2017

Study information

• Verified date: September 2017
• Source: All India Institute of Medical Sciences, Bhubaneswar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 15, 2017
• Est. primary completion date: August 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• Folic acid
tab. Folic acid 5 mg
• Vitamin B12
tab. Vitamin B12 500 mcg

Drug:
• Oral hypoglycemic agents [Metformin +/- Sulfonylurea]
Patients receiving either of the following oral hypoglycemic agents Sulfonylurea Metformin Metformin plus Sulfonylurea

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences, Bhubaneswar	Bhubaneswar	Odisha

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, Bhubaneswar

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		8 weeks
Secondary	Fasting plasma glucose		8 weeks
Secondary	Fasting plasma insulin		8 weeks
Secondary	Insulin Resistance	Using Homeostatic model assessment (HOMA2 calculator which uses fasting plasma glucose and plasma insulin values to calculate insulin resistance)	8 weeks
Secondary	Serum total cholesterol		8 weeks
Secondary	Serum triacylglycerol		8 weeks
Secondary	Serum Low-density lipoprotein (LDL)		8 weeks
Secondary	Serum High-density lipoprotein (HDL)		8 weeks
Secondary	Serum Very Low-density lipoprotein (VLDL)		8 weeks
Secondary	Serum Homocysteine		8 weeks
Secondary	Serum Adiponectin		8 weeks
Secondary	Serum Tumor Necrosis Factor (TNF)		8 weeks
Secondary	Serum Interleukin-6 (IL-6)		8 weeks
Secondary	Serum C reactive protein (CRP)		8 weeks