Atherosclerosis
Conditions
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.
Interventions
DIETARY_SUPPLEMENTVitamin D3
50,000 units taken orally once a week for 8 weeks
Sponsors
Rockefeller University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Small LDL particle concentration | Visit 5 |
Countries
United States
Outcome results
None listed