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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008384
• Other study ID #: MAP-0683
• Status: Completed
• Phase: N/A
• First received: October 22, 2009
• Last updated: May 31, 2012
• Start date: October 2009
• Est. completion date: October 2011

Study information

• Verified date: May 2012
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Dietary Supplement:
• Vitamin D3
50,000 units taken orally once a week for 8 weeks

Locations

Country	Name	City	State
United States	The Rockefeller University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Rockefeller University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Small LDL particle concentration		Visit 5	No