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Effects of Vitamin D on Lipids

Effects of Vitamin D on Lipids

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00723385
Enrollment
130
Registered
2008-07-28
Start date
2008-07-31
Completion date
2012-07-31
Last updated
2015-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia, Vitamin D Deficiency

Keywords

cholesterol, LDL-cholesterol, cholecalciferol, lipids, C-reactive protein

Brief summary

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.

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.

Interventions

DIETARY_SUPPLEMENTVitamin 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

OTHERPlacebo

Administration of placebo for 12 weeks with repeated D measurements

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
LDL-cholesterol12 weeks

Secondary

MeasureTime frame
Vitamin D and metabolite concentrations with supplementation and time course of repletion in deficient or insufficient subjects12 weeks
Measures of inflammatory markers12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026