Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of Vitamin D on Lipids

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Janice B. Schwartz, MD, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00723385
First received: July 24, 2008
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Hypercholesterolemia
Vitamin D Deficiency
Drug: Vitamin D (1000 or 2000 IU/day)
Other: Placebo

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

Resource links provided by NLM:


Further study details as provided by Jewish Home, San Francisco:

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 ]

Enrollment: 45
Study Start Date: July 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo administration for 12 weeks with repeated 25-OH D determinations over 12 weeks, dietary, sunshine questionnaire recording
Other: Placebo
Administration of placebo for 12 weeks with repeated D measurements
Experimental: Vitamin D
Vitamin D (1000 or 2000 IU/day)
Drug: 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 Name: cholecalciferol

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

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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Jewish Home
San Francisco, California, United States, 94112
Sponsors and Collaborators
Jewish Home, San Francisco
Investigators
Principal Investigator: Janice B. Schwartz, MD,FACC,FAHA Jewish Home, University of California, San Francisco
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janice B. Schwartz, MD, Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00723385     History of Changes
Other Study ID Numbers: AG0104, 5R01AG015982
Study First Received: July 24, 2008
Last Updated: September 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Jewish Home, San Francisco:
cholesterol
LDL-cholesterol
cholecalciferol
lipids
C-reactive protein

Additional relevant MeSH terms:
Hypercholesterolemia
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Malnutrition
Metabolic Diseases
Nutrition Disorders
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014