The Effect of Vitamin D Repletion on Small Low Density Lipoprotein (LDL) Particle Number in Subjects at Elevated Cardiovascular Risk

Vitamin D is a fat-soluble vitamin that is naturally present in very few foods, added to others, and available as a dietary supplement. It is also produced in the body when ultraviolet rays from sunlight strike the skin and trigger vitamin D synthesis. Vitamin D is essential for promoting calcium absorption and maintaining adequate serum calcium and phosphate concentrations to enable normal mineralization of bone and bone growth. Without sufficient vitamin D, bones can become thin, brittle, or misshapen. Vitamin D sufficiency prevents rickets in children and osteomalacia in adults. Together with calcium, vitamin D also helps protect older adults from osteoporosis. Many people have low levels of Vitamin D. Replacing Vitamin D is thought to help lower the risk of heart disease. Vitamin D may be helpful, but it could also be harmful. The investigators are studying the effect of Vitamin D on the level of a harmful kind of cholesterol. Participants will have their cholesterol levels measured and then receive either Vitamin D or a placebo. After 2 months of treatment, the investigators will measure their cholesterol levels again.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Rockefeller University

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age > 18 years and < 85 years
Vitamin D 25-OH level <20 ng/ml
One of the following risk factors:

Known coronary artery disease (CAD) or a CAD equivalent (e.g. diabetes, chronic kidney disease, etc)
BMI > 30 kg/m2
Random Glucose Level > 200mg/dl
Increased Waist Circumference (male: > 40in; Females: > 35in.)
Decreased HDL (Male: < 40mg/dl; Female: < 50mf/dl)
Framingham Risk Score > 10%
hsCRP > 2 mg/L

Exclusion criteria

Serum phosphorus level > 5.5 mg/dl
Estimated GFR <30 ml/min/1.73m2
Use of Vitamin D >400 IU/day within 1 month of most recent Vitamin D 25-OH determination
Use of calcitriol or other "activated" vitamin D
Change in statin, ezetimibe, niacin, fibrate dose within 1 month
Concurrent participation in an investigational drug study
Have any other condition, which in the opinion of the investigator, should prohibit the participation in the study
Serum calcium level >10.5 mg/dl
anti-epileptic medication
triglycerides > 400 mg/dL
BMI > 40 kg/m2
Evidence of cirrhosis as evidenced by AST > 3 x upper limit, ALT > 3 x upper limit, bilirubin > 1.5 mg/dL , albumin < 3.0 g/dL, PT > 14.5 sec
Pregnant or Lactating Females

Treatment and study plan

Vitamin D3

Dietary Supplement

50,000 units taken orally once a week for 8 weeks

Primary outcomes

Small LDL particle concentration

Time frame: Visit 5

Sponsors and collaborators

Lead sponsor

Rockefeller University

Other

Registry information

Official study title

The Effect of Vitamin D Repletion on Small LDL Particle Number in Subjects at Elevated Cardiovascular Risk

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Nov 5, 2009
Registry last updated: Jun 1, 2012

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.

Published trials that share one or more normalized conditions with this study.

Completed