Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
National Institute on Aging (NIA) |
---|---|
Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00723385 |
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 |
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
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lynn Kane, RN | 415-406-1579 | |
Contact: Carol Kartunen, RN | 415-406-1578 |
United States, California | |
Jewish Home | Recruiting |
San Francisco, California, United States, 94112 | |
Contact: Lynn Kane, RN 415-406-1579 lkane@jhsf.org | |
Contact: Carol Kartunen, RN 415-406-1578 ckartunen@jhsf.org | |
Principal Investigator: Janice B. Schwartz, MD |
Principal Investigator: | Janice B. Schwartz, MD,FACC,FAHA,FAGS | Jewish Home, University of California, San Francisco |
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: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00723385 History of Changes |
Health Authority: | United States: Federal Government |
cholesterol LDL-cholesterol ergocalciferol |
cholecalciferol lipids C-reactive protein |
Cholecalciferol Hyperlipidemias Metabolic Diseases Ergocalciferols Trace Elements Bone Density Conservation Agents Vitamin D |
Vitamins Micronutrients Hypercholesterolemia Metabolic Disorder Dyslipidemias Lipid Metabolism Disorders |
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 |