Effects of Vitamin D on Lipids

Hypercholesterolemia Clinical Trial

Official title:

Effects of Vitamin D on Lipids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723385
• Other study ID #: AG0104
• Secondary ID: 5R01AG015982
• Status: Completed
• Phase: N/A
• First received: July 24, 2008
• Last updated: April 7, 2015
• Start date: July 2008
• Est. completion date: July 2012

Study information

• Verified date: April 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Hypercholesterolemia
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D (1000 or 2000 IU/day)
Dose titration beginning with 1000 IU/day and either remaining at 1000 IU/day for weeks 7-12 if normalized D levels at 6 weeks or increasing to 2000 IU/day for weeks 7-12 if levels not normalized at week 6

Other:
• Placebo
Administration of placebo for 12 weeks with repeated D measurements

Locations

Country	Name	City	State
United States	Jewish Home	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View Citation

Kane L, Moore K, Lütjohann 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/j — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-cholesterol		12 weeks	No
Secondary	Vitamin D and metabolite concentrations with supplementation and time course of repletion in deficient or insufficient subjects		12 weeks	No
Secondary	Measures of inflammatory markers		12 weeks	No