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

This study has been completed.
Sponsor:
Information provided by:
ProMedica Health System
ClinicalTrials.gov Identifier:
NCT00985361
First received: September 25, 2009
Last updated: May 5, 2010
Last verified: October 2009
History of Changes
  Purpose

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 Intervention
Type 2 Diabetes Mellitus
 Dietary Supplement: Vitamin D3 2000 international units daily
Dietary Supplement: Vitamin C 500mg daily

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D Supplementation on Hemoglobin A1c in Patients With Uncontrolled Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ProMedica Health System:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: October 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985361

Locations
United States, Ohio
Flower Hospital Family Medicine Residency
Sylvania, Ohio, United States, 43560
Toledo Hospital Family Medicine Residency
Toledo, Ohio, United States, 43606
Center for Health Services
Toledo, Ohio, United States, 43606
Sponsors and Collaborators
ProMedica Health System
Investigators
Principal Investigator: Mate M Soric, PharmD ProMedica Health System
  More Information

No publications provided by ProMedica Health System

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mate Soric, ProMedica
ClinicalTrials.gov Identifier: NCT00985361     History of Changes
Other Study ID Numbers: 09-055
Study First Received: September 25, 2009
Last Updated: May 5, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ascorbic Acid
Cholecalciferol
Vitamin D
Ergocalciferols
 Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 23, 2013