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OpenTrials
Completed

NCT Number: NCT00749918

Effect of Vitamin D Deficiency and Vitamin D Supplementation on Glucose Metabolism

This study was intended to evaluate the effect of vitamin D supplementation on insulin sensitivity and pancreatic islet beta-cell function. Our hypothesis was that vitamin D supplementation to normal levels in patients with impaired fasting glucose will result in improved insulin sensitivity and improved beta cell function.

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Key information

Conditions

PreDiabetes Avitaminosis Deficiency Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Prediabetic State Vitamin D Deficiency

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota, Division of Endocrinology

Minneapolis, Minnesota, 55455, United States

About this study

A modified frequently sampled intravenous glucose tolerance (mFSIGT) test was used. On day 0, baseline 22 time point mFSIGT was performed. Subjects were then treated with cholecalciferol (vitamin D3) supplementation - 10,000 IU/day - for 28 consecutive days. mFSIGT was then repeated measuring glucose, insulin and c-peptide at all time points. 25-OH vitamin D, PTH, and calcium were also measured at time point 0 pre and post vitamin D supplementation. Data was analyzed using the Bergman/Boston minimal model for insulin homeostasis with MinMod Millennium software.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Impaired fasting glucose
  • Adult, age between 18 and 65
  • Serum vitamin D level below 30 ng/mL

Exclusion criteria

  • History of nephrolithiasis
  • Any medications that can effect insulin sensitivity or beta cell function (i.e. antipsychotics, metformin)
  • Pregnancy
  • Liver disease
  • Renal disease

Treatment and study plan

Cholecalciferol (vitamin D3)

Dietary Supplement

Oral capsules of cholecalciferol, 5000 IU/ capsule, two capsules daily for one month.

Other names: Cholecalciferol by BIO-TECH Pharmacal, Inc.

Primary outcomes

  1. Assessment of insulin sensitivity before and after oral vitamin D3 supplementation with 10,000 IU/day for one month.

    Time frame: At baseline and after 4 weeks of vitamin D supplementation

Secondary outcomes

  1. Monitor effect of vitamin D supplementation with 10,000 IU/day for one month on serum calcium and parathyroid hormone levels.

    Time frame: One month

  2. Assess effect of vitamin D supplementation on beta cell function as measured by analysis of data collected through a modified FSIGT test.

    Time frame: One month

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Hennepin Healthcare Research Institute

Registry information

Official study title

Improved Insulin Sensitivity With Therapeutic Vitamin D Replacement in Pre-Diabetic Vitamin D Deficient Individuals

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 9, 2008
Registry last updated
Oct 20, 2008

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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