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OpenTrials
Completed

NCT Number: NCT00723385

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jewish Home

San Francisco, California, 94112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D (1000 or 2000 IU/day)

Dietary Supplement

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 names: cholecalciferol

Placebo

Other

Administration of placebo for 12 weeks with repeated D measurements

Primary outcomes

  1. LDL-cholesterol

    Time frame: 12 weeks

Secondary outcomes

  1. Vitamin D and metabolite concentrations with supplementation and time course of repletion in deficient or insufficient subjects

    Time frame: 12 weeks

  2. Measures of inflammatory markers

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jul 28, 2008
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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