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Completed

NCT Number: NCT00876928

Vitamin D in Minorities With Prediabetes

Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D levels will delay the development of diabetes.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charles Drew University

Los Angeles, California, 90059, United States

About this study

Low vitamin D levels 1) are associated with abnormalities in insulin secretion and insulin action, 2) predict the development of diabetes in those without diabetes, and 3) are more common in people with diabetes. Minority populations (African-Americans and Latinos) are more likely to have both low levels of vitamin D and diabetes. This study will identify minority individuals who are at increased risk for diabetes (those with central obesity, family history of diabetes in first degree relatives and either with hypertension or being treated for hypertension), and determine if they have both pre-diabetes, ie, impaired fasting glucose and/or impaired glucose tolerance, and low levels of vitamin D. Those that have both will be randomized to either high doses of vitamin D or placebo and insulin secretion and action as well as changes in the oral glucose tolerance test (reversion to normal, maintenance of pre-diabetes or development of diabetes) will be monitored at 3 month intervals for one year. This study will test the hypothesis that the increased amount of diabetes in minority populations may be due in part to low levels of vitamin D and whether supplementing this vitamin may delay the development of diabetes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age greater than 40.
  • Impaired fasting glucose (FPG level greater than 100 and less than 126 mg/dl); and/or
  • Impaired glucose tolerance (2-h plasma glucose concentration after 75 gram glucose load greater than 140 and less than 200 mg/dl)
  • Serum 25-OHD less than 30 ng/ml
  • Able and willing to provide informed consent

Exclusion criteria

  • FPG greater than 126 mg/dl or 2-hour-OGTT plasma glucose greater than 200 mg/dl
  • Major psychiatric disorder on medication (excluding successfully treated depression)
  • Diagnosed diabetes mellitus
  • HIV/AIDS
  • Major hematological, hepatic (AST/ALT levels greater than or equal to 2 times normal) or renal eGFR less than 60 ml/min) disorder
  • History of carcinoma, except skin basal cell or squamous cell skin carcinomas
  • Heart failure, unstable angina or history of a myocardial infarction
  • Alcohol or substance abuse
  • Current treatment with glucocorticoids
  • Current treatment with diabetes medications, including metformin
  • Cushing's syndrome
  • Primary hyperparathyroidism
  • Nephrolithiasis
  • Pregnancy or breast-feeding
  • Regular visits to a tanning salon (unlikely in this minority population)

Treatment and study plan

Vitamin D

Drug

liquid vitamin D3 dissolved in medium chain triglyceride once a week

Placebo

Drug

medium chain triglyceride given once per week

Primary outcomes

  1. Percent of Subjects Who Develop Diabetes

    Time frame: one year

    Diabetes defined by a FPG>=126 mg/dl or a 2-hr glucose concentration on an OGTT of >=200 mg/dl

Secondary outcomes

  1. Disposition Index

    Time frame: Baseline, 3, 6, 9, 12 months

    Measure of insulin secretion multiplied by measure of insulin sensitivity,both derived from oral glucose tolerance test; higher values are better

Sponsors and collaborators

Lead sponsor

Charles Drew University of Medicine and Science

Other

Collaborators

  • American Diabetes Association

Registry information

Official study title

Effect of Vitamin D Supplementation on Pre-Diabetes in a Minority Population

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 7, 2009
Registry last updated
Jun 14, 2013

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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