NCT00985361CompletedNot Applicable
Effect of Vitamin D Supplementation on Hemoglobin A1c in Patients With Uncontrolled Type 2 Diabetes Mellitus
ProMedica Health System6 sites in 1 country37 target enrollmentStarted: October 1, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 37
- Locations
- 6
- Primary Endpoint
- Hemoglobin A1c
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Hemoglobin A1c
Time Frame: 3 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (6)
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