Effects of Vitamin D on Lipids

University of California San Francisco (UCSF)

Status: Completed

Conditions: Vitamin D Deficiency; Hypercholesterolemia

Treatments: Dietary Supplement: Vitamin D (1000 or 2000 IU/day); Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00723385

AG0104

5R01AG015982 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

130 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo administration for 12 weeks with repeated 25-OH D determinations over 12 weeks, dietary, sunshine questionnaire recording

Treatment:

Other: Placebo

Vitamin D

Experimental group

Description:

Vitamin D (1000 or 2000 IU/day)

Treatment:

Dietary Supplement: Vitamin D (1000 or 2000 IU/day)