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Completed

NCT Number: NCT00985361

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Flower Hospital Family Medicine Residency, Sylvania, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3 2000 international units daily

Dietary Supplement

Vitamin D3 2000 international unit tablets once daily for 3 months

Vitamin C 500mg daily

Dietary Supplement

Vitamin C 500mg tablets once daily for 3 months

Primary outcomes

  1. Hemoglobin A1c

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

ProMedica Health System

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 28, 2009
Registry last updated
May 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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