Effects of Vitamin D on Lipids

Not Applicable

Completed

• Conditions: Vitamin D Deficiency; Hypercholesterolemia

• Registration Number: NCT00723385
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-24
• Study First Submitted QC: 2008-07-24
• Study First Posted: 2008-07-28
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
LDL-cholesterol	12 weeks

Secondary Outcome Measures

Name	Time	Method
Vitamin D and metabolite concentrations with supplementation and time course of repletion in deficient or insufficient subjects	12 weeks
Measures of inflammatory markers	12 weeks

Trial Locations

Locations (1)

Jewish Home; 🇺🇸 San Francisco, California, United States