Full Text View
Tabular View
No Study Results Posted
Related Studies
Effects of Vitamin D on Lipids
This study is currently recruiting participants.
Verified by National Institute on Aging (NIA), January 2009
First Received: July 24, 2008   Last Updated: January 29, 2009   History of Changes
Sponsored by: 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

Genetics Home Reference related topics: hypercholesterolemia
MedlinePlus related topics: Cholesterol
Drug Information available for: Ergocalciferol Cholecalciferol Lipids Vitamin D
U.S. FDA Resources
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

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
Contact: Carol Kartunen, RN 415-406-1578

Locations
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            
Sponsors and Collaborators
Investigators
Principal Investigator: Janice B. Schwartz, MD,FACC,FAHA,FAGS Jewish Home, University of California, San Francisco
  More Information

Publications:
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

Keywords provided by National Institute on Aging (NIA):
cholesterol
LDL-cholesterol
ergocalciferol
cholecalciferol
lipids
C-reactive protein

Study placed in the following topic categories:
Cholecalciferol
Hyperlipidemias
Metabolic Diseases
Ergocalciferols
Trace Elements
Bone Density Conservation Agents
Vitamin D
Vitamins
Micronutrients
Hypercholesterolemia
Metabolic Disorder
Dyslipidemias
Lipid Metabolism Disorders

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 May 07, 2009