Effect of Vitamin D Supplementation on Hemoglobin A1c in Patients With Uncontrolled Type 2 Diabetes Mellitus

May 5, 2010 updated by: ProMedica Health System
The purpose of this study is to determine if daily supplementation with 2000 International Units of Vitamin D will improve hemoglobin A1c in uncontrolled type 2 diabetics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vitamin D is typically understood to support musculoskeletal health when administered concomitantly with calcium. A number of recent studies suggest, however, that this important nutrient may play a significant role in many pathophysiological processes, including diabetes mellitus. With the prevalence of diabetes mellitus ever increasing, novel mechanisms for controlling blood glucose and hemoglobin A1c are being sought to help prevent the costly and debilitating complications of this chronic disease.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

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
    • Ohio
      • Sylvania, Ohio, United States, 43560
        • Flower Hospital Family Medicine Residency
      • Toledo, Ohio, United States, 43606
        • Center for Health Services
      • Toledo, Ohio, United States, 43606
        • Toledo Hospital Family Medicine Residency

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

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Hemoglobin A1c >7% measured in the 3 months prior to randomization
  • Age 21 to 75 years

Exclusion Criteria:

  • Renal insufficiency (defined as CrCl <30mL/min)
  • Gestational diabetes
  • Malabsorption syndrome
  • Patients taking vitamin D supplements at doses >400 international units daily

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D 2000 international units daily
Dietary supplement: Vitamin D3 2000 international units daily
Vitamin D3 2000 international unit tablets once daily for 3 months
Active Comparator: Vitamin C 500mg daily
Dietary supplement: Vitamin C 500mg daily
Vitamin C 500mg tablets once daily for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin A1c
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

ProMedica Health System

Investigators

  • Principal Investigator: Mate M Soric, PharmD, ProMedica Health System

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

October 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

September 25, 2009

First Submitted That Met QC Criteria

September 25, 2009

First Posted (Estimate)

September 28, 2009

Study Record Updates

Last Update Posted (Estimate)

May 6, 2010

Last Update Submitted That Met QC Criteria

May 5, 2010

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-055

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on Vitamin D3 2000 international units daily

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe