Glucose Intolerance, Insulin Resistance
Conditions
Brief summary
A Prospective Double-Blinded, Placebo Controlled, Randomized Trial comparing a single dose of Vitamin D (Colecalciferol) 300.00UI to placebo on patients with insulin resistance. Primary Outcome: Blood glucose and homeostasis model assessment for insulin resistance (HOMA-R) after 90 days. Study hypothesis: Vitamin D treatment may improve insulin resistance and decrease glucose level, since there is an association between hypovitaminosis D and increased insulin resistance.
Interventions
DRUGColecalciferol (Vitamin D3) 300.000 UI
Colecalciferol (Vitamin D3) 300.000 UI Capsule, Single Dose
DRUGPlacebo
Placebo Capsule, Single Dose
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Fasten Blood Glucose \> 100 mg/dL and \< 126 mg/dL * Age \> 18 years
Exclusion criteria
* Diabetes Mellitus * Use of metformin * Vitamin D Use * Hypercalcemia * Chronic Hepatitis * HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Glucose Level | Baseline and day 90 |
Secondary
| Measure | Time frame |
|---|---|
| Blood Calcium Level | Baseline and day 90 |
| HOMA-R | Baseline and day 90 |
Countries
Brazil
Outcome results
None listed