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

May 31, 2012 updated by: Rockefeller University

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Visit 5
Visit 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rockefeller University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • MAP-0683

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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