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

July 24, 2008
September 17, 2013
July 2008
July 2012   (final data collection date for primary outcome measure)
LDL-cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00723385 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effects of Vitamin D on Lipids
Effects of Vitamin D on Lipids

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Hypercholesterolemia
  • Vitamin D Deficiency
  • 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
  • Other: Placebo
    Administration of placebo for 12 weeks with repeated D measurements
  • Placebo Comparator: Placebo
    Placebo administration for 12 weeks with repeated 25-OH D determinations over 12 weeks, dietary, sunshine questionnaire recording
    Intervention: Other: Placebo
  • Experimental: Vitamin D
    Vitamin D (1000 or 2000 IU/day)
    Intervention: Drug: Vitamin D (1000 or 2000 IU/day)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00723385
AG0104, 5R01AG015982
No
Janice B. Schwartz, MD, University of California, San Francisco
Jewish Home, San Francisco
National Institute on Aging (NIA)
Principal Investigator: Janice B. Schwartz, MD,FACC,FAHA Jewish Home, University of California, San Francisco
Jewish Home, San Francisco
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP