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Diabetes Mellitus, Type 2Phase 2/3NCT02786823

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

A Phase 2/3 study testing Folic acid, Vitamin B12 and Oral hypoglycemic agents [Metformin +/- Sulfonylurea] in people with Diabetes Mellitus, Type 2, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 30 to 65 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Folic acid, Vitamin B12 and Oral hypoglycemic agents [Metformin +/- Sulfonylurea]
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteIndia
Study dates
1 May 2017to 15 Sep 2017
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

India1 site

  • All India Institute of Medical Sciences, Bhubaneswar

    Bhubaneswar, Odisha, 751019

Other trials in India

About this study

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.

Read the 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.

Being tested
Folic acid, Vitamin B12, Oral hypoglycemic agents [Metformin +/- Sulfonylurea]
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Folic acidDietary supplement

    tab. Folic acid 5 mg

  • Vitamin B12Dietary supplement

    tab. Vitamin B12 500 mcg

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

    Also called Metformin, Sulfonylurea

    Patients receiving either of the following oral hypoglycemic agents

    1. Sulfonylurea
    2. Metformin
    3. Metformin plus Sulfonylurea
Study groups in NCT02786823
Study groupRoleWhat they receive
Folic acidExperimentalTwenty 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
Receives: Dietary Supplement: Folic acid; Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]
Vitamin B12ExperimentalTwenty 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
Receives: Dietary Supplement: Vitamin B12; Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]
"Folic acid" and "Vitamin B12"ExperimentalTwenty 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
Receives: Dietary Supplement: Folic acid; Dietary Supplement: Vitamin B12; Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]
ControlActive comparatorTwenty type-2 diabetes patients with standard Oral hypoglycemic agents [Metformin +/- Sulfonylurea] will be recruited and receive no additional supplementation
Receives: Drug: Oral hypoglycemic agents [Metformin +/- Sulfonylurea]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    Measured: 8 weeks

Secondary outcomes (13)

  1. Fasting plasma glucose

    Measured: 8 weeks

  2. Fasting plasma insulin

    Measured: 8 weeks

  3. Insulin Resistance

    Using Homeostatic model assessment (HOMA2 calculator which uses fasting plasma glucose and plasma insulin values to calculate insulin resistance)

    Measured: 8 weeks

  4. Serum total cholesterol

    Measured: 8 weeks

  5. Serum triacylglycerol

    Measured: 8 weeks

  6. Serum Low-density lipoprotein (LDL)

    Measured: 8 weeks

  7. Serum High-density lipoprotein (HDL)

    Measured: 8 weeks

  8. Serum Very Low-density lipoprotein (VLDL)

    Measured: 8 weeks

  9. Serum Homocysteine

    Measured: 8 weeks

  10. Serum Adiponectin

    Measured: 8 weeks

  11. Serum Tumor Necrosis Factor (TNF)

    Measured: 8 weeks

  12. Serum Interleukin-6 (IL-6)

    Measured: 8 weeks

  13. Serum C reactive protein (CRP)

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2016 (estimated)
  2. Study start1 May 2017
  3. Primary completion15 Aug 2017
  4. Study completion15 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02786823
Sponsor's protocol ID
T/lM-F/Biochem/15/22
Status last verified
Sep 2017
First submitted
25 May 2016
Last updated
19 Sep 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Folic acid, Vitamin B12 and Oral hypoglycemic agents [Metformin +/- Sulfonylurea] in people with Diabetes Mellitus, Type 2, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02786823.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.

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