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

The Effect of Vitamin D Repletion on Small 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.

Study Overview

• Status: Completed
• Conditions: Atherosclerosis
• Intervention / Treatment: Dietary supplement: Vitamin D3

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • The Rockefeller University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: placebo
EXPERIMENTAL: Vitamin D3; Vitamin D3 given for 8 weeks	Dietary supplement: Vitamin D3; 50,000 units taken orally once a week for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Small LDL particle concentration	Visit 5

Collaborators and Investigators

• Sponsor: Rockefeller University
• Investigators: Principal Investigator: Manish Ponda, MD, The Rockefeller University

Publications and helpful links

General Publications

• Ponda MP, Dowd K, Finkielstein D, Holt PR, Breslow JL. The short-term effects of vitamin D repletion on cholesterol: a randomized, placebo-controlled trial. Arterioscler Thromb Vasc Biol. 2012 Oct;32(10):2510-5. doi: 10.1161/ATVBAHA.112.254110. Epub 2012 Sep 4.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): October 1, 2011

Study Registration Dates

• First Submitted: October 22, 2009
• First Submitted That Met QC Criteria: November 4, 2009
• First Posted (ESTIMATE): November 5, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): June 1, 2012
• Last Update Submitted That Met QC Criteria: May 31, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: MAP-0683