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
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.
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.
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