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

NCT01008384 | Completed

• 1 other identifier: MAP-0683
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Small LDL particle concentration

  Visit 5

Study Arms (2)

placebo

NO INTERVENTION

Vitamin D3

EXPERIMENTAL

Vitamin D3 given for 8 weeks

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

50,000 units taken orally once a week for 8 weeks

Vitamin D3

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years and \< 85 years
• Vitamin D 25-OH level \<20 ng/ml
• 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

You may not qualify if:

• Serum phosphorus level \> 5.5 mg/dl
• Estimated GFR \<30 ml/min/1.73m2
• Use of Vitamin D \>400 IU/day within 1 month of most recent Vitamin D 25-OH determination
• Use of calcitriol or other "activated" vitamin D
• Change in statin, ezetimibe, niacin, fibrate dose within 1 month
• Concurrent participation in an investigational drug study
• Have any other condition, which in the opinion of the investigator, should prohibit the participation in the study
• Serum calcium level \>10.5 mg/dl
• anti-epileptic medication
• triglycerides \> 400 mg/dL
• BMI \> 40 kg/m2
• 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
• Pregnant or Lactating Females

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

The Rockefeller University

New York, New York, 10065, United States

Location

Related Publications (1)

• 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.

  PMID: 22947589 DERIVED

MeSH Terms

Conditions

Atherosclerosis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Manish Ponda, MD

  The Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: November 5, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 1, 2012

Record last verified: 2012-05

Locations

US (1)