Effects of Rosuvastatin on the Immune System in Healthy Volunteers With Normal Cholesterol
Completed
Conditions studied: Healthy Volunteers, Statins, Immune Modulation
In brief
Background: \- The drug rosuvastatin (also called Crestor) is used to lower cholesterol levels in people with elevated cholesterol levels. Recent studies have suggested that rosuvastatin may affect the immune system and reduce inflammation, but the reason for this effect is unclear. Researchers are interested in testing the effect of rosuvastatin on the immune systems of healthy volunteers with good cholesterol levels. Objectives: \- To evaluate the effect of rosuvastatin on the immune systems of healthy volunteers. Eligibility: \- Healthy individuals at least 18 years of age who have an acceptable blood level of LDL cholesterol (below 160). Design: * Participants will be screened with a medical history and physical examination, as well as blood tests to check general health, cholesterol levels, liver function, and the C-reactive protein (which responds to inflammation). * Participants will not be permitted to take most prescription and over-the-counter medications that affect the immune system, including antihistamines and certain pain relievers. For 1 week before the study, participants will have a wash-out period without any of these medications. * Participants will take rosuvastatin daily for 4 weeks, always in the evening (to ensure consistent blood sample results). * Participants will provide blood samples at the following time points: (1) immediately before the start of the rosuvastatin treatment, (2) after 2 weeks of treatment, (3) after 4 weeks of treatment, and (4) 2 weeks after the end of treatment.
Key facts
- Study ID
- NCT01200836
- Run by
- National Heart, Lung, and Blood Institute (NHLBI)
- People needed
- 20
- Starts
- 2010-07-01
- Expected to finish
- 2018-10-04
- Last updated by the study team
- 2018-10-09
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Female subjects may not be pregnant or lactating due to minor side effects of use of statins in a non-benefit study.
- Abnormal LFT s, i.e. AST > 34 U/L; ALT > 41 U/L; T. Bilirubin >1.0 mg/dL; Alkaline Phosphatasse > 116 U/L.
- Other contraindication to statins (i.e. inadequately treated hypothyroidism, renal impairment, liver disease, elevated transaminases, diabetes mellitus or hypersensitivity to a statin)
- Subjects unable to comprehend the investigational nature of the procedure or unable or unwilling to sign the consent.
- Statin usage within the last six months prior to enrollment.
- Diabetes mellitus
- Subjects not willing to participate in the gene expression analysis and whole genome expression and polymorphisms studies portion of this protocol.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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