Clinical trial NCT00723385: Effects of Vitamin D on Lipids
Official title: Effects of Vitamin D on Lipids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Vitamin D Deficiency
Keywords: cholesterol
LDL-cholesterol
cholecalciferol
lipids
C-reactive protein
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2008-07-28
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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

Primary outcomes:
measure: LDL-cholesterol
timeFrame: 12 weeks
Secondary outcomes:
measure: Vitamin D and metabolite concentrations with supplementation and time course of repletion in deficient or insufficient subjects
timeFrame: 12 weeks
measure: Measures of inflammatory markers
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Jewish Home
state: California
Study officials:
affiliation: Jewish Home, University of California, San Francisco
name: Janice B. Schwartz, MD,FACC,FAHA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Autier P, Gandini S. Vitamin D supplementation and total mortality: a meta-analysis of randomized controlled trials. Arch Intern Med. 2007 Sep 10;167(16):1730-7. doi: 10.1001/archinte.167.16.1730.
citation: Wang TJ, Pencina MJ, Booth SL, Jacques PF, Ingelsson E, Lanier K, Benjamin EJ, D'Agostino RB, Wolf M, Vasan RS. Vitamin D deficiency and risk of cardiovascular disease. Circulation. 2008 Jan 29;117(4):503-11. doi: 10.1161/CIRCULATIONAHA.107.706127. Epub 2008 Jan 7.
citation: Kane L, Moore K, Lutjohann D, Bikle D, Schwartz JB. Vitamin D3 effects on lipids differ in statin and non-statin-treated humans: superiority of free 25-OH D levels in detecting relationships. J Clin Endocrinol Metab. 2013 Nov;98(11):4400-9. doi: 10.1210/jc.2013-1922. Epub 2013 Sep 12.