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

ClinicalTrials.gov processed this record on April 17, 2014