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

Sponsor
ProMedica Health System (Other)
Overall Status
Completed
CT.gov ID
NCT00985361
Collaborator
(none)
37
3
2
5
12.3
2.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Vitamin D3 2000 international units daily
  • Dietary Supplement: Vitamin C 500mg daily
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Vitamin D Supplementation on Hemoglobin A1c in Patients With Uncontrolled Type 2 Diabetes Mellitus
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
Mar 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Hemoglobin A1c [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Flower Hospital Family Medicine Residency Sylvania Ohio United States 43560
2 Center for Health Services Toledo Ohio United States 43606
3 Toledo Hospital Family Medicine Residency Toledo Ohio United States 43606

Sponsors and Collaborators

  • ProMedica Health System

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00985361
Other Study ID Numbers:
  • 09-055
First Posted:
Sep 28, 2009
Last Update Posted:
May 6, 2010
Last Verified:
Oct 1, 2009

Study Results

No Results Posted as of May 6, 2010