| Trial ID: | L5374 |
| Source ID: | NCT00436475
|
| Associated Drug: |
Vitamin D3 2,000 Iu Orally Once Daily
|
| Title: |
Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes
|
| Acronym: |
CaDDM
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00436475/results
|
| Conditions: |
Glucose Intolerance|Type 2 Diabetes Mellitus|Metabolic Syndrome
|
| Interventions: |
DRUG: Vitamin D3 2,000 IU orally once daily|DRUG: Calcium Carbonate 400 mg orally twice daily|DRUG: Vitamin D3-Placebo|DRUG: Calcium-Placebo
|
| Outcome Measures: |
Primary: Chang in Disposition Index, a Measure of Beta Cell Function, Range is 0 to infinity Lower is better., baseline and 4 months | Secondary: Change in Hemoglobin A1c, This outcome measures change in Hemoglobin A1c, a measure of glycemia, Baseline to 4 months
|
| Sponsor/Collaborators: |
Sponsor: Tufts Medical Center | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
92
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2007-09
|
| Completion Date: |
2009-11
|
| Results First Posted: |
2019-07-30
|
| Last Update Posted: |
2019-07-30
|
| Locations: |
Tufts-New England Medical Center, Boston, Massachusetts, 02111, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00436475
|
