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OpenTrials
Completed

NCT Number: NCT00436475

Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes

The purpose of the randomized trial is to quantify the effect of vitamin D and calcium supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for type 2 diabetes.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tufts-New England Medical Center

Boston, Massachusetts, 02111, United States

About this study

There is animal and human observational evidence to suggest that vitamin D and calcium are important in modifying t2DM risk but there are critical gaps in our knowledge about the clinical magnitude of the association with t2DM and potential mechanisms in humans. We are conducting a randomized trial to quantify the effect of vitamin D and calcium supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for t2DM. We anticipate that the research proposed in this application is significant because it will provide the basis for defining feasible nutritional interventions that promotes prevention of t2DM. Based on the results of the proposed studies and future work in this area, vitamin D and calcium supplementation can assume an important role in the treatment of t2DM and in the prevention of the disease in the 41 million Americans who are at risk of developing t2DM.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Ethnicity: all ethnic groups
  • Gender: men and women
  • Age
  • Lower age limit: 40 years inclusive
  • Upper age limit: NONE
  • BMI
  • Lower BMI limit: 25 inclusive
  • Upper BMI limit: 40 inclusive
  • Glucose Intolerance / Mild Diabetes defined as
  • Fasting glucose ≥100 mg/dl OR
  • 2-hr glucose after OGTT ≥140 mg/dl OR
  • 5.8 ≤ Hemoglobin A1c ≤ 7

Major Exclusion Criteria:

  • Diabetes requiring pharmacotherapy
  • Smoking
  • Hyperparathyroidism
  • Hypercalcemia (Calcium > 10.5 mg/dl)
  • Kidney stone
  • Pregnancy

Treatment and study plan

Vitamin D3 2,000 IU orally once daily

Drug

Vitamin D3 2,000 IU orally once daily

Calcium Carbonate 400 mg orally twice daily

Drug

Calcium Carbonate 400 mg orally twice daily

Vitamin D3-Placebo

Drug

Vitamin D3-Placebo

Calcium-Placebo

Drug

Calcium-Placebo

Primary outcomes

  1. Chang in Disposition Index, a Measure of Beta Cell Function

    Time frame: baseline and 4 months

    Range is 0 to infinity Lower is better.

Secondary outcomes

  1. Change in Hemoglobin A1c

    Time frame: Baseline to 4 months

    This outcome measures change in Hemoglobin A1c, a measure of glycemia

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: CaDDM

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 19, 2007
Registry last updated
Jul 30, 2019

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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