Healthy VolunteersNCT01200836
Effects of Rosuvastatin on the Immune System in Healthy Volunteers With Normal Cholesterol
An observational study of Healthy Volunteers and Statins, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Statins, Immune Modulation
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2010to 4 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteer (health status confirmed by brief History and Physical Exam and routine blood work as determined by the screening protocol)
- Age greater than or equal to18 years of age
- LDL < 160 mg/dL
- Ten subjects must have hsCRP < 2mg/L, and ten subjects must have hsCRP greater than or equal to 2 mg/L
- Subjects with psoriasis that are otherwise healthy, who have not received any systemic imunosuppression in the past 6 months
- Subjects with fasting glucose < 125 mg/dL
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
Statins are drugs that inhibit cholesterol synthesis and are used extensively for primary and secondary prevention of heart disease. Their benefit to patients with heart diseases appears to exceed that predicted from cholesterol lowering alone. A recent study has found benefits of statin therapy in patients with normal cholesterol and high C-reactive protein, a marker of inflammation, suggesting that statins exert an anti inflammatory effect in addition to the well known cholesterol lowering activity. Studies in mice have revealed mixed observations regarding the role of statins in inflammation. Therefore the Center for Human Immunology, Autoimmunity and Inflammation is conducting this trial to study the effects of statins on the immune system and the inflammatory response in healthy volunteers with normal cholesterol levels, and normal or elevated C-reactive protein levels.
The primary objective is to characterize the immune system before and during statin therapy.
- Conditions
- Healthy Volunteers, Statins, Immune Modulation
- Keywords
- Statins, Immune Modulation, Healthy Volunteer
What is being measured
The primary outcome is the main question the study is designed to answer.
To elucidate the effects of a four week course of statins on the immune system in healthy volunteers with normal cholesterol with or without elevated C- reactive protein.
An understanding of the mechanism by which statins effect the immune system may help us better define the patient population that might benefit from such therapy and potentially develop drugs that act more selectively and potently on the relevant immunologic pathway(s). We will also address the potential antithrombotic activity of statins.This study has been slow to recruit healthy subjects with elevated CRP, often because subjects with elevated CRP had mild abnormalities on a detailed history and physical exam, such as impaired fasting glucose. In addition, preliminary analysis of the cohort of normal CRP suggests a significant reduction in serum IL-17 during statin therapy. Psoriasis is an inflammatory disease that affects the skin and the joints, is assumed to be IL-17 driven17, and subjects are usually free of systemic imunosuppression.
Secondary outcomes (1)
To describe the effects of statins on platelet activity and coagulation during thrombus formation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study start1 Jul 2010
- Study completion4 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Angelique Biancotto, Ph.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200836
- Sponsor's protocol ID
- 100165
- Other IDs
- 10-H-0165
- Status last verified
- 4 Oct 2018
- First submitted
- 10 Sep 2010
- Last updated
- 9 Oct 2018
- Results posted
- No
Publications
Karmaus PW, Shi M, Perl S, Biancotto A, Candia J, Cheung F, Kotliarov Y, Young N, Fessler MB; CHI Consortium. Effects of rosuvastatin on the immune system in healthy volunteers with normal serum cholesterol. JCI Insight. 2019 Nov 1;4(21):e131530. doi: 10.1172/jci.insight.131530.
PubMed 31573980
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rosuvastatin on the Immune System in Healthy Volunteers With Normal Cholesterol
- ClinicalTrials.gov ID
- NCT01200836
- Acronym / sponsor ID
- 100165
- Conditions
- Healthy Volunteers, Statins, Immune Modulation
- Keywords
- Statins, Immune Modulation, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 1 Jul 2010
- Study completion
- 4 Oct 2018
- First posted
- 14 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Statins are drugs that inhibit cholesterol synthesis and are used extensively for primary and secondary prevention of heart disease. Their benefit to patients with heart diseases appears to exceed that predicted from cholesterol lowering alone. A recent study has found benefits of statin therapy in patients with normal cholesterol and high C-reactive protein, a marker of inflammation, suggesting that statins exert an anti inflammatory effect in addition to the well known cholesterol lowering activity. Studies in mice have revealed mixed observations regarding the role of statins in inflammation. Therefore the Center for Human Immunology, Autoimmunity and Inflammation is conducting this trial to study the effects of statins on the immune system and the inflammatory response in healthy volunteers with normal cholesterol levels, and normal or elevated C-reactive protein levels.
The primary objective is to characterize the immune system before and during statin therapy.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy volunteer (health status confirmed by brief History and Physical Exam and routine blood work as determined by the screening protocol)
- Age greater than or equal to18 years of age
- LDL < 160 mg/dL
- Ten subjects must have hsCRP < 2mg/L, and ten subjects must have hsCRP greater than or equal to 2 mg/L
- Subjects with psoriasis that are otherwise healthy, who have not received any systemic imunosuppression in the past 6 months
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To elucidate the effects of a four week course of statins on the immune system in healthy volunteers with normal cholesterol with or without elevated C- reactive protein.
An understanding of the mechanism by which statins effect the immune system may help us better define the patient population that might benefit from such therapy and potentially develop drugs that act more selectively and potently on the relevant immunologic pathway(s). We will also address the potential antithrombotic activity of statins.This study has been slow to recruit healthy subjects with elevated CRP, often because subjects with elevated CRP had mild abnormalities on a detailed history and physical exam, such as impaired fasting glucose. In addition, preliminary analysis of the cohort of normal CRP suggests a significant reduction in serum IL-17 during statin therapy. Psoriasis is an inflammatory disease that affects the skin and the joints, is assumed to be IL-17 driven17, and subjects are usually free of systemic imunosuppression.
1 secondary outcome
To describe the effects of statins on platelet activity and coagulation during thrombus formation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Derived from this study: PubMed 31573980Karmaus PW, Shi M, Perl S, Biancotto A, Candia J, Cheung F, Kotliarov Y, Young N, Fessler MB; CHI Consortium. Effects of rosuvastatin on the immune system in healthy volunteers with normal serum cholesterol. JCI Insight. 2019 Nov 1;4(21):e131530. doi: 10.1172/jci.insight.131530.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelique Biancotto, Ph.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers and Statins, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To elucidate the effects of a four week course of statins on the immune system in healthy volunteers with normal cholesterol with or without elevated C- reactive protein.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01200836, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018; AzTrials last refreshed its copy on 8 Nov 2026.