Phase 2
N=92
Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes
Glucose Intolerance · Type 2 Diabetes Mellitus · Metabolic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00436475 ↗Enrolled (actual)
92
Serious AEs
2.2%
Results posted
Jul 2019
Primary outcome: Primary: Chang in Disposition Index, a Measure of Beta Cell Function — 287; 314; -122; -129 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vitamin D3 2,000 IU orally once daily (Drug); Calcium Carbonate 400 mg orally twice daily (Drug); Vitamin D3-Placebo (Drug); Calcium-Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Tufts Medical Center
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chang in Disposition Index, a Measure of Beta Cell Function |
287; 314; -122; -129 | — |
| SECONDARY Change in Hemoglobin A1c |
0.05; 0.08; 0.09; 0.18 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00436475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.