Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Glucose Intolerance, Type 2 Diabetes Mellitus, Metabolic Syndrome

In brief

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.

Key facts

Study ID

NCT00436475

Run by

Tufts Medical Center

People needed

92

Starts

2007-09-01

Expected to finish

2009-11-01

Last updated by the study team

2019-07-30

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

Where it is running

• Tufts-New England Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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