| Trial ID: | L5292 |
| Source ID: | NCT01019642
|
| Associated Drug: |
Cholecalciferol
|
| Title: |
Vitamin D, C-reactive Protein and Insulin Resistance
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Low-intensity Chronic Inflammation|Insulin Resistance
|
| Interventions: |
DRUG: cholecalciferol|DRUG: placebo
|
| Outcome Measures: |
Primary: Serum C-reactive protein concentrations, measured by a high-sensitivity assay -nephelometry-., 3 and 6 months|Insulin resistance, measured by HOMA-IR index, 3 and 6 months | Secondary: Serum 25-OH-vitamin D3 levels, 3 and 6 months
|
| Sponsor/Collaborators: |
Sponsor: Instituto Nacional de Salud Publica, Mexico | Collaborators: Instituto Mexicano del Seguro Social|Ellison Medical / International Nutrition Foundation|Tufts University
|
| Gender: |
FEMALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
104
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-03
|
| Completion Date: |
2008-10
|
| Results First Posted: |
|
| Last Update Posted: |
2009-11-25
|
| Locations: |
Instituto Mexicano del Seguro Social, Cuernavaca, Morelos, 62450, Mexico
|
| URL: |
https://clinicaltrials.gov/show/NCT01019642
|
