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

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ClinicalTrials.gov Identifier: NCT02786823
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Debapriya Bandyopadhyay, All India Institute of Medical Sciences, Bhubaneswar

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Dietary Supplement: Folic acid Dietary Supplement: Vitamin B12 Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea] Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Folic Acid and Vitamin B12 Supplementation on Biochemical Parameters in Subjects With Type-2 Diabetes
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : August 15, 2017
Actual Study Completion Date : September 15, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Dietary Supplement: Folic acid
tab. Folic acid 5 mg

Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]

Patients receiving either of the following oral hypoglycemic agents

  1. Sulfonylurea
  2. Metformin
  3. Metformin plus Sulfonylurea
Other Name: Metformin, Sulfonylurea
Experimental: 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
 Dietary Supplement: Vitamin B12
tab. Vitamin B12 500 mcg

Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]

Patients receiving either of the following oral hypoglycemic agents

  1. Sulfonylurea
  2. Metformin
  3. Metformin plus Sulfonylurea
Other Name: Metformin, Sulfonylurea
Experimental: "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
 Dietary Supplement: Folic acid
tab. Folic acid 5 mg

Dietary Supplement: Vitamin B12
tab. Vitamin B12 500 mcg

Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]

Patients receiving either of the following oral hypoglycemic agents

  1. Sulfonylurea
  2. Metformin
  3. Metformin plus Sulfonylurea
Other Name: Metformin, Sulfonylurea
Active Comparator: Control
Twenty type-2 diabetes patients with standard Oral hypoglycemic agents [Metformin +/- Sulfonylurea] will be recruited and receive no additional supplementation
 Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]

Patients receiving either of the following oral hypoglycemic agents

  1. Sulfonylurea
  2. Metformin
  3. Metformin plus Sulfonylurea
Other Name: Metformin, Sulfonylurea


Outcome Measures
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Primary Outcome Measures :
  1. HbA1c [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Fasting plasma glucose [ Time Frame: 8 weeks ]
  2. Fasting plasma insulin [ Time Frame: 8 weeks ]
  3. Insulin Resistance [ Time Frame: 8 weeks ]
    Using Homeostatic model assessment (HOMA2 calculator which uses fasting plasma glucose and plasma insulin values to calculate insulin resistance)

  4. Serum total cholesterol [ Time Frame: 8 weeks ]
  5. Serum triacylglycerol [ Time Frame: 8 weeks ]
  6. Serum Low-density lipoprotein (LDL) [ Time Frame: 8 weeks ]
  7. Serum High-density lipoprotein (HDL) [ Time Frame: 8 weeks ]
  8. Serum Very Low-density lipoprotein (VLDL) [ Time Frame: 8 weeks ]
  9. Serum Homocysteine [ Time Frame: 8 weeks ]
  10. Serum Adiponectin [ Time Frame: 8 weeks ]
  11. Serum Tumor Necrosis Factor (TNF) [ Time Frame: 8 weeks ]
  12. Serum Interleukin-6 (IL-6) [ Time Frame: 8 weeks ]
  13. Serum C reactive protein (CRP) [ Time Frame: 8 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786823


Locations
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India
All India Institute of Medical Sciences, Bhubaneswar
Bhubaneswar, Odisha, India, 751019
Sponsors and Collaborators
All India Institute of Medical Sciences, Bhubaneswar
Investigators
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Principal Investigator: Debapriya Bandyopadhyay, M.D. All India Institute of Medical Sciences, Bhubaneswar
More Information
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Responsible Party: Dr. Debapriya Bandyopadhyay, Assistant Professor, Department of Biochemistry, All India Institute of Medical Sciences, Bhubaneswar, All India Institute of Medical Sciences, Bhubaneswar
ClinicalTrials.gov Identifier: NCT02786823    
Other Study ID Numbers: T/lM-F/Biochem/15/22
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Folic Acid
Vitamin B 12
 Metformin
Hypoglycemic Agents
Vitamins
Micronutrients
Physiological Effects of Drugs
Hematinics
Vitamin B Complex