Effect of Vitamin D Supplementation on Hemoglobin A1c

April 22, 2015 updated by: Prabhat Pokhrel, Ascension Genesys Hospital

Does Vitamin D Supplement Alter Serum Level of Glycosylated Hemoglobin in Adult Patients Between 34-74 Years With Type 2 Diabetes Mellitus and Vitamin D Deficiency?

This is a prospective, randomized, non-blinded interventional study that will investigate the effect of a vitamin D supplement on HbA1c in patients with uncontrolled type 2 diabetes mellitus (DM) and vitamin D deficiency. The goal is to investigate whether correcting vitamin D deficiency will alter the HbA1c level in patients with type 2 DM and lower than normal vitamin D level. My hypothesis is that correcting vitamin D deficiency decreases HbA1c levels in patients with type 2 DM and vitamin D deficiency.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The total number of study subjects expected to be enrolled in this study is about 150. Study subjects included in this study will be men and women between 34-69 years of age who have been diagnosed with type 2 DM based on at least one of the American Diabetic Association criteria. These criteria are 1) fasting blood glucose higher than 125 mg/dL once with symptoms of diabetes (increased urination, increased appetite, increased thirst) or two times without symptoms; 2) random blood glucose more than 200 mg/dL once with symptoms or two times without symptoms of diabetes; 3) two hour glucose tolerance test more than 200 mg/dL once with symptoms or two times without symptoms; or 4) a random glycosylated hemoglobin more than 6.5 % two times. The age group for this research was selected based on the review of the literature on diabetes and vitamin D. Patients with known primary hyperparathyroidism, sarcoidosis, tuberculosis, cancer, potential terminal illness, history of serum creatinine more than 2.0 mg/dL, vitamin D supplement more than 200 IU/day, inflammatory bowel disease and history of hypercalcemia and kidney stones will be excluded from this study. For this project, vitamin D deficiency is defined as serum vitamin D level lower than 30 ng/mL and uncontrolled diabetes is defined as HbA1C level above 7.0. Although there is more than one recommended normal level of vit. D in the blood, most experts agree that the optimum serum level of vitamin D should be above 30 ng/mL. All subjects will be receiving standard of care for DM offered to them by his or her physician.

The investigators will investigate if different but fixed doses of vitamin D (600 IU a day vs 50,000 IU once every other week) when given to patients with type 2 DM and vitamin D deficiency have different effects on HbA1c level at the end of 24 weeks. A baseline blood draw, and fasting blood draws will be taken at 12 and 24 weeks for blood sugar levels, Vit D levels, and HgbA1c. Subjects with vitamin D deficiency will be randomly assigned to either group 1 or 2 and will be supplemented with either 600 IU of vitamin D/day (Group 1) or 50,000 IU of vitamin D every 2 weeks for 24 weeks (Groups 2). Patients who are not vitamin D deficient will be followed as the control group (Group 3) and will not be given any vitamin D supplement.Research subjects will be advised not to take any vitamin D or multivitamin while participating in this study. Subjects will be given 100 tablets of 600 IU of vitamin D in a bottle if they belong to Group 1. If they have been advised to take vitamin D 50,000 IU once every 14 days (Group 2), they will be given altogether 13 tablets of 50,000 of vitamin D each in a separate brown envelope with date written on the envelop and subjects will be asked to take vitamin D only on the date written on the envelop.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Flint, Michigan, United States, 48503
        • Genesys East Flint Campus Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

34 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Hgb A1c greater then 7.0
  • Adults aged 34 to 69 years.

Exclusion Criteria:

  • known primary hyperparathyroidism, sarcoidosis, tuberculosis, cancer, potential terminal illness,
  • history of serum creatinine more than 2.0 mg/dL,
  • vitamin D supplement more than 200 IU/day
  • history of inflammatory bowel disease, hypercalcemia or kidney stones

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lower dose vitamin D
Fixed daily doses of 600 IU vitamin D oral supplementation.
Dietary supplement: Vitamin D
600 IU daily oral supplementation
Dietary supplement: Vitamin D
50,000 IU supplementation bi-monthly
Experimental: Higher dose vitamin D
50,000 IU supplementation bi-monthly.
Dietary supplement: Vitamin D
600 IU daily oral supplementation
Dietary supplement: Vitamin D
50,000 IU supplementation bi-monthly
No Intervention: Control Group
Patients will be followed from baseline to 12 and 24 week follow up. Patients do not receive any research treatment or intervention beyond the standard care of their diabetes. This group are patients with normal levels of Vitamin D.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in serum levels of Hemoglobin A1c.
Time Frame: Change from baseline assessed at 12 wk and 24 wk.
Serum levels of hemoglobin A1c will be tested in the laboratory from blood draws conducted at baseline and at 12 and 24 weeks from a fasting blood sample.
Change from baseline assessed at 12 wk and 24 wk.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ascension Genesys Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kimberly R Barber, PhD, Ascension Genesys Hospital
  • Principal Investigator: Prabhat K Pokhrel, MD, Ascension Genesys Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GRMC 10 0023

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