The Effect of Quercetin in Sarcoidosis

This study has been completed.

Sponsor:

Collaborator:

ZonMw: The Netherlands Organisation for Health Research and Development

Information provided by:

Maastricht University Medical Center

ClinicalTrials.gov Identifier:

NCT00402623

First received: November 20, 2006

Last updated: February 21, 2008

Last verified: February 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

November 20, 2006

Last Updated Date

February 21, 2008

Start Date ^ICMJE

January 2006

Primary Completion Date

January 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

antioxidant status after 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
inflammatory status after 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

antioxidant status after 24 hours
inflammatory status after 24 hours

Change History

Complete list of historical versions of study NCT00402623 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

plasma quercetin concentration after 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
plasma malondialdehyde (MDA) levels after 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

plasma quercetin concentration after 24 hours
plasma malondialdehyde (MDA) levels after 24 hours

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Effect of Quercetin in Sarcoidosis

Official Title ^ICMJE

The Effect of Quercetin on the Increased Inflammatory and Decreased Antioxidant Status in Sarcoidosis

Brief Summary

The exact cause of the chronic lung disease sarcoidosis is still unknown. Consequently, a complete efficacious treatment is still not available. Earlier studies indicate an important key role for oxidative stress, i.e. an imbalance between the production of and the protection against ROS, in the etiology of sarcoidosis. Antioxidants, needed for protection against ROS, are indeed lower in sarcoidosis. Therefore, antioxidant therapy to strengthen the reduced antioxidant defense might be efficacious in sarcoidosis treatment. Since ROS are also capable of initiating and mediating inflammation, antioxidant therapy might also mitigate the elevated inflammation that occurs in sarcoidosis. The flavonoid quercetin possesses both anti-oxidative and anti-inflammatory capacities and might therefore serve as a good candidate for antioxidant therapy in sarcoidosis.

Therefore, the aim of the present study is to determine the effect of quercetin supplementation in sarcoidosis patients on markers of both oxidative stress and inflammation.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Sarcoidosis

Intervention ^ICMJE

Dietary Supplement: quercetin
1000 mg quercetin within 24 hours
Other: placebo

Study Arm (s)

Placebo Comparator: 1
placebo

Intervention: Other: placebo
Active Comparator: 2
quercetin (food supplement)

Intervention: Dietary Supplement: quercetin

Publications *

Boots AW, Drent M, de Boer VC, Bast A, Haenen GR. Quercetin reduces markers of oxidative stress and inflammation in sarcoidosis. Clin Nutr. 2011 Aug;30(4):506-12. Epub 2011 Feb 15.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2006

Primary Completion Date

January 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

clinical diagnosis of sarcoidosis with emphasize on pulmonary sarcoidosis
no smoking
no treatment

Exclusion Criteria:

clinical diagnosis (and treatment) of other diseases
symptoms of sarcoidosis in other organs besides the lung
use of food supplements or vitamins

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00402623

Other Study ID Numbers ^ICMJE

MEC 05.142.5

Has Data Monitoring Committee

Responsible Party

Dr. A.W. Boots, Maastricht University

Study Sponsor ^ICMJE

Maastricht University

Collaborators ^ICMJE

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators ^ICMJE

Study Chair:	Aalt Bast, PhD	Maastricht University
Principal Investigator:	Agnes W Boots, PhD	Maastricht University
Study Director:	Guido R Haenen, PhD	Maastricht University

Information Provided By

Maastricht University Medical Center

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top