Effect of Folic Acid and Vitamin B12 Supplementation in Subjects With Type 2 Diabetes
NCT ID: NCT02786823
Last Updated: 2017-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
80 participants
INTERVENTIONAL
2017-05-01
2017-09-15
Brief Summary
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* 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
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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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
tab. Folic acid 5 mg
Oral hypoglycemic agents [Metformin +/- Sulfonylurea]
Patients receiving either of the following oral hypoglycemic agents
1. Sulfonylurea
2. Metformin
3. Metformin plus Sulfonylurea
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
tab. Vitamin B12 500 mcg
Oral hypoglycemic agents [Metformin +/- Sulfonylurea]
Patients receiving either of the following oral hypoglycemic agents
1. Sulfonylurea
2. Metformin
3. Metformin plus Sulfonylurea
"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
Folic acid
tab. Folic acid 5 mg
Vitamin B12
tab. Vitamin B12 500 mcg
Oral hypoglycemic agents [Metformin +/- Sulfonylurea]
Patients receiving either of the following oral hypoglycemic agents
1. Sulfonylurea
2. Metformin
3. Metformin plus Sulfonylurea
Control
Twenty type-2 diabetes patients with standard Oral hypoglycemic agents \[Metformin +/- Sulfonylurea\] will be recruited and receive no additional supplementation
Oral hypoglycemic agents [Metformin +/- Sulfonylurea]
Patients receiving either of the following oral hypoglycemic agents
1. Sulfonylurea
2. Metformin
3. Metformin plus Sulfonylurea
Interventions
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Folic acid
tab. Folic acid 5 mg
Vitamin B12
tab. Vitamin B12 500 mcg
Oral hypoglycemic agents [Metformin +/- Sulfonylurea]
Patients receiving either of the following oral hypoglycemic agents
1. Sulfonylurea
2. Metformin
3. Metformin plus Sulfonylurea
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
30 Years
65 Years
ALL
No
Sponsors
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All India Institute of Medical Sciences, Bhubaneswar
OTHER
Responsible Party
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Dr. Debapriya Bandyopadhyay
Assistant Professor, Department of Biochemistry, All India Institute of Medical Sciences, Bhubaneswar
Principal Investigators
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Debapriya Bandyopadhyay, M.D.
Role: PRINCIPAL_INVESTIGATOR
All India Institute of Medical Sciences, Bhubaneswar
Locations
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All India Institute of Medical Sciences, Bhubaneswar
Bhubaneswar, Odisha, India
Countries
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Other Identifiers
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T/lM-F/Biochem/15/22
Identifier Type: -
Identifier Source: org_study_id