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

Not Applicable

Completed

• Conditions: Atherosclerosis
• Interventions: Dietary Supplement: Vitamin D3

• Registration Number: NCT01008384
• Lead Sponsor: Rockefeller University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-22
• Study First Submitted QC: 2009-11-04
• Study First Posted: 2009-11-05
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Age > 18 years and < 85 years

2. Vitamin D 25-OH level <20 ng/ml

3. 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

1. Serum phosphorus level > 5.5 mg/dl
2. Estimated GFR <30 ml/min/1.73m2
3. Use of Vitamin D >400 IU/day within 1 month of most recent Vitamin D 25-OH determination
4. Use of calcitriol or other "activated" vitamin D
5. Change in statin, ezetimibe, niacin, fibrate dose within 1 month
6. Concurrent participation in an investigational drug study
7. Have any other condition, which in the opinion of the investigator, should prohibit the participation in the study
8. Serum calcium level >10.5 mg/dl
9. anti-epileptic medication
10. triglycerides > 400 mg/dL
11. BMI > 40 kg/m2
12. 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
13. Pregnant or Lactating Females

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D3	Vitamin D3	Vitamin D3 given for 8 weeks

Primary Outcome Measures

Name	Time	Method
Small LDL particle concentration	Visit 5

Trial Locations

Locations (1)

The Rockefeller University; 🇺🇸 New York, New York, United States