Effect of Vitamin D Repletion on Insulin Resistance and Systemic Inflammation

Plain-language summary

This study compares vitamin D supplementation with placebo, evaluating its effect on insulin resistance and inflammation in people with low vitamin D levels and insulin resistance. It included people with low blood vitamin D and insulin resistance. It was a Phase 2 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Albert Einstein College of Medicine

Intervention

Vitamin D, Placebo

Start date

3/13/2009

Estimated completion

9/3/2015

Countries

United States

Related genes

Locations

• The Bronx, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Serum 25(OH)D\<20ng/ml
* Insulin Resistant based on HOMA-IR score of \>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