Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Glucose Intolerance Type 2 Diabetes Mellitus Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily

Group Type OTHER

Vitamin D3 2,000 IU orally once daily

Intervention Type DRUG

Vitamin D3 2,000 IU orally once daily

Calcium Carbonate 400 mg orally twice daily

Intervention Type DRUG

Calcium Carbonate 400 mg orally twice daily

2

Vitamin D3 2,000 IU daily plus Calcium-Placebo twice daily

Group Type OTHER

Vitamin D3 2,000 IU orally once daily

Intervention Type DRUG

Vitamin D3 2,000 IU orally once daily

Calcium-Placebo

Intervention Type DRUG

Calcium-Placebo

3

Vitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily

Group Type OTHER

Calcium Carbonate 400 mg orally twice daily

Intervention Type DRUG

Calcium Carbonate 400 mg orally twice daily

Vitamin D3-Placebo

Intervention Type DRUG

Vitamin D3-Placebo

4

Vitamin D3-Placebo plus Calcium-Placebo

Group Type OTHER

Vitamin D3-Placebo

Intervention Type DRUG

Vitamin D3-Placebo

Calcium-Placebo

Intervention Type DRUG

Calcium-Placebo

Interventions

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Vitamin D3 2,000 IU orally once daily

Intervention Type DRUG

Calcium Carbonate 400 mg orally twice daily

Intervention Type DRUG

Vitamin D3-Placebo

Intervention Type DRUG

Calcium-Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ethnicity: all ethnic groups
* Gender: men and women
* Age

1. Lower age limit: 40 years inclusive
2. Upper age limit: NONE
* BMI

1. Lower BMI limit: 25 inclusive
2. Upper BMI limit: 40 inclusive
* Glucose Intolerance / Mild Diabetes defined as

1. Fasting glucose ≥100 mg/dl OR
2. 2-hr glucose after OGTT ≥140 mg/dl OR
3. 5.8 ≤ Hemoglobin A1c ≤ 7