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
  Purpose

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.


Condition Intervention
Sarcoidosis
Dietary Supplement: quercetin
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Quercetin on the Increased Inflammatory and Decreased Antioxidant Status in Sarcoidosis

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 18
Study Start Date: January 2006
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
placebo
Other: placebo
Active Comparator: 2
quercetin (food supplement)
Dietary Supplement: quercetin
1000 mg quercetin within 24 hours

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00402623

Locations
Netherlands
Maastricht University
Maastricht, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Study Chair: Aalt Bast, PhD Maastricht University
Principal Investigator: Agnes W Boots, PhD Maastricht University
Study Director: Guido R Haenen, PhD Maastricht University
  More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. A.W. Boots, Maastricht University
ClinicalTrials.gov Identifier: NCT00402623     History of Changes
Other Study ID Numbers: MEC 05.142.5
Study First Received: November 20, 2006
Last Updated: February 21, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
sarcoidosis
quercetin
supplementation
oxidative stress
inflammation

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Quercetin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014