Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Tufts Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Tufts Medical Center
• Treatments: Calcium; Calcium Carbonate; Calcium, Dietary; Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

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

Major Exclusion Criteria:

• Diabetes requiring pharmacotherapy

• Smoking

• Hyperparathyroidism

• Hypercalcemia (Calcium > 10.5 mg/dl)

• Kidney stone

• Pregnancy