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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo

Group Type NO_INTERVENTION

No interventions assigned to this group

Vitamin D3

Vitamin D3 given for 8 weeks

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Vitamin D3

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No