Ldl Vitamin D

Ldl Vitamin D

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.

Condition or disease	Intervention/treatment	Phase
Atherosclerosis	Dietary Supplement: Vitamin D3	Not Applicable

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Study Type :	Interventional  (Clinical Trial)
Actual Enrollment :	150 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Double (Participant, Investigator)
Official Title:	The Effect of Vitamin D Repletion on Small LDL Particle Number in Subjects at Elevated Cardiovascular Risk
Study Start Date :	October 2009
Actual Primary Completion Date :	October 2011
Actual Study Completion Date :	October 2011

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :

1. Small LDL particle concentration [ Time Frame: Visit 5 ]
   

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008384

Locations

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

Sponsors and Collaborators

Rockefeller University

Investigators

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Principal Investigator:	Manish Ponda, MD	The Rockefeller University

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

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Responsible Party:	Rockefeller University
ClinicalTrials.gov Identifier:	NCT01008384
Other Study ID Numbers:	MAP-0683
First Posted:	November 5, 2009    Key Record Dates
Last Update Posted:	June 1, 2012
Last Verified:	May 2012

Additional relevant MeSH terms:

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Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Vitamin D	Cholecalciferol Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents

Ldl Vitamin D

Source: https://clinicaltrials.gov/ct2/show/NCT01008384