Effect of Vitamin D Supplementation on Hemoglobin A1c in Patients With Uncontrolled Type 2 Diabetes Mellitus
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 |
---|---|---|
|
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
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
- Hemoglobin A1c [3 months]
Eligibility Criteria
Criteria
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.- 09-055