Effects of Vitamin D on Lipids - Full Text View

Sponsor:	National Institute on Aging (NIA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00723385

Purpose

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

Condition	Intervention
Hypercholesterolemia	Drug: Vitamin D2 Drug: Vitamin D3 Drug: Placebo

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Pharmacodynamics Study
Official Title:	Effects of Vitamin D on Lipids

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Ergocalciferol Cholecalciferol Lipids Vitamin D

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

LDL-cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Vitamin D and metabolite concentrations with supplementation and time course of repletion in deficient or insufficient subjects [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Measures of inflammatory markers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	July 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Vitamin D2 1000 IU/day orally for 12 weeks
2: Experimental	Drug: Vitamin D3 1000 IU/day orally for 12 weeks
3: Placebo Comparator	Drug: Placebo matching placebo daily orally for 12 weeks

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 oral vitamin D supplementation will lower LDL-cholesterol and total cholesterol concentrations. Subhypotheses are that HDL-cholesterol, triglycerides, lipoprotein(a), hs C-reactive protein and Hemoglobin A1c will not be affected, and that effects will be greatest in persons with vitamin D deficiency or insufficiency in the non-supplemented state.

This is a 12-week study of the effects of supplementation with 1000 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Any medically stable person able to swallow pills

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723385

Contacts

Contact: Lynn Kane, RN

415-406-1579

Locations

United States, California
Jewish Home	Recruiting
San Francisco, California, United States, 94112
Contact: Lynn Kane, RN 415-406-1579 lkane@jhsf.org
Principal Investigator: Janice B. Schwartz, MD

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Janice B. Schwartz, MD,FACC,FAHA,FAGS

Jewish Home, University of California, San Francisco

More Information

Publications:

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.

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. Epub 2008 Jan 7.

Responsible Party:	Jewish Home; University of California, San Francisco ( a. Janice B. Schwartz, M.D., FACC, FAHA, FAGS, Director of Research )
Study ID Numbers:	AG0104, 5R01AG015982
Study First Received:	July 24, 2008
Last Updated:	December 17, 2009
ClinicalTrials.gov Identifier:	NCT00723385 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

cholesterol
LDL-cholesterol
ergocalciferol

cholecalciferol
lipids
C-reactive protein

Additional relevant MeSH terms:

Cholecalciferol
Hyperlipidemias
Metabolic Diseases
Growth Substances
Physiological Effects of Drugs
Ergocalciferols
Bone Density Conservation Agents

Pharmacologic Actions
Vitamin D
Vitamins
Micronutrients
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010