Phase 2
Completed N=19
Effect of Vitamin D Repletion on Insulin Resistance and Systemic Inflammation
Source: ClinicalTrials.gov NCT01354964 ↗Enrolled (actual)
19
Serious AEs
5.3%
Results posted
Mar 2020
Primary outcomePrimary: Percent Change in Hepatic Insulin Sensitivity — -19.2; 5.8; -33.66; 113.7 percent change
Summary
The purpose of this research is to study the effects of Vitamin D supplementation on the body's response to insulin (a hormone that controls blood sugar), on inflammation, and on specific cells and processes in fat tissue.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Hepatic Insulin Sensitivity |
-19.2; 5.8; -33.66; 113.7 | — |
| SECONDARY Percent Change in Peripheral Glucose Uptake |
0.48; -2.54; -0.98; 1.75 | — |
| SECONDARY Evaluated Expression of Pro-inflammatory Gene TNF-α |
0.023; 0.021; 0.036; 0.008 | — |
| SECONDARY Evaluated Expression of Pro-inflammatory Gene IL-6 |
0.019; 0.047; 0.022; 0.050 | — |
| SECONDARY Evaluated Expression of Pro-inflammatory Gene iNOS |
0.004; 0.008; 0.003; 0.005 | — |
| SECONDARY Evaluated Expression of Pro-inflammatory Gene PAI-1 |
0.020; 0.032; 0.008; 0.019 | — |
Eligibility Criteria
Inclusion Criteria
- Serum 25(OH)D 3
- Able and willing to provide informed consent
- BMI 20-35
Exclusion Criteria
- HIV/AIDS
- History of any cancer
- Sarcoidosis
- Alcohol or substance abuse
- Cushing's syndrome
- Primary hyperparathyroidism
- Nephrolithiasis
- Pregnancy or breastfeeding
- Regular visits to a tanning salon
- Hypercalcemia or hypocalcemia
- Untreated or uncontrolled hypertension
- Any chronic illness requiring medication, other than arthritis, hypertension and hyperlipidemia
Data sourced from ClinicalTrials.gov (NCT01354964). 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. Informational only — not medical advice.