Effects of Vitamin D on Lipids

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hypercholesterolemia Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo administration for 12 weeks with repeated 25-OH D determinations over 12 weeks, dietary, sunshine questionnaire recording

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Administration of placebo for 12 weeks with repeated D measurements

Vitamin D

Vitamin D (1000 or 2000 IU/day)

Group Type EXPERIMENTAL

Vitamin D (1000 or 2000 IU/day)

Intervention Type 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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Administration of placebo for 12 weeks with repeated D measurements

Intervention Type OTHER

Other Intervention Names

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cholecalciferol

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes