Expired Study
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San Francisco, California 94112


Purpose:

The purpose of this study is to examine whether oral vitamin D supplementation in people with inadequate vitamin D concentrations will lower LDL-cholesterol and total cholesterol concentrations.


Study summary:

Data from previous trials suggest a protective role of vitamin D in cardiovascular disease. A recent meta-analysis of trials with at least 5 years of follow-up of vitamin D supplementation concluded that intake of vitamin D supplements may decrease total mortality, but that the relationship between baseline vitamin D status, dose of vitamin D supplements, and total mortality rates remains to be investigated. An even more recent analysis of vitamin D concentrations found that participants with vitamin D deficiency and hypertension were about twice as likely as people without hypertension and vitamin D deficiency to have a cardiovascular event during the study. The main hypothesis to be tested is that normalization of vitamin D levels will lower LDL-cholesterol and total cholesterol concentrations in people with inadequate vitamin D concentrations as determined by circulating 25-OH vitamin D. Subhypotheses are that HDL-cholesterol, triglycerides, lipoprotein(a), hs C-reactive protein and Hemoglobin A1c will not be affected, and that cyp3a-metabolized medication levels will decrease with vitamin D replacement. This is a 12-week randomized double-blind dose titration study of the effects of supplementation with 1000-2000 IU vitamin D on lipid and vitamin D concentrations. Dietary intake of vitamin D will be estimated by dietary recall questionnaire or analysis of three non-consecutive 24-hour dietary intake logs.


Criteria:

Inclusion Criteria: - Any medically stable person able to swallow pills - Inadequate vitamin D status at screening visit Exclusion Criteria: - Clinical instability of underlying disease process (e.g., recent hospitalization, change of dosages of medications within the prior two weeks, or new medications within one month) - Recent transfusion - Severe renal failure or dialysis - Hypercalcemia - Malignancy under active treatment - Feeding tube - Intestinal bypass surgery - Inability to swallow tablets


NCT ID:

NCT00723385


Primary Contact:

Principal Investigator
Janice B. Schwartz, MD,FACC,FAHA
Jewish Home, University of California, San Francisco


Backup Contact:

N/A


Location Contact:

San Francisco, California 94112
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 22, 2018

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