MedTrace Logo

Effects of Rosuvastatin on the Immune System in Healthy Volunteers With Normal Cholesterol

NCT01200836 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2018-10-09

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteers
  • Statins
  • Immune Modulation

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Angelique Biancotto, Ph.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-01
Completion
2018-10-04

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01200836 on ClinicalTrials.gov