Effect of Folic Acid and Vitamin B12 Supplementation in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): Folic acid; Vitamin B12; Oral hypoglycemic agents [Metformin +/- Sulfonylurea]
Intervention type(s): Dietary Supplement; Dietary Supplement; Drug
Intervention description(s): tab. Folic acid 5 mg; tab. Vitamin B12 500 mcg; Patients receiving either of the following oral hypoglycemic agents
Sulfonylurea
Metformin
Metformin plus Sulfonylurea
Other intervention name(s): Metformin, Sulfonylurea
Intervention MeSH terms: Folic Acid; Vitamin B 12; Metformin; Hypoglycemic Agents
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment