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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT01008384
First received: October 22, 2009
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Atherosclerosis
 Dietary Supplement: Vitamin D3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: The Effect of Vitamin D Repletion on Small LDL Particle Number in Subjects at Elevated Cardiovascular Risk

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • Small LDL particle concentration [ Time Frame: Visit 5 ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: October 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01008384

Locations
United States, New York
The Rockefeller University
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Investigators
Principal Investigator: Manish Ponda, MD The Rockefeller University
  More Information

No publications provided by Rockefeller University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT01008384     History of Changes
Other Study ID Numbers: MAP-0683
Study First Received: October 22, 2009
Last Updated: May 31, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cholecalciferol
Vitamin D
 Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 21, 2013