Clinical trial NCT01008384: The Effect of Vitamin D Repletion on Small Low Density Lipoprotein (LDL) Particle Number in Subjects at Elevated Cardiovascular Risk
Official title: The Effect of Vitamin D Repletion on Small LDL Particle Number in Subjects at Elevated Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Lead sponsor: Rockefeller University
Sponsor class: OTHER
First posted: 2009-11-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.


Eligibility 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

Primary outcomes:
measure: Small LDL particle concentration
timeFrame: Visit 5
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The Rockefeller University
state: New York
Study officials:
affiliation: The Rockefeller University
name: Manish Ponda, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.