- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00402623
The Effect of Quercetin in Sarcoidosis
The Effect of Quercetin on the Increased Inflammatory and Decreased Antioxidant Status in Sarcoidosis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Maastricht, Netherlands, 6200 MD
- Maastricht University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: 1
placebo
|
|
|
Active Comparator: 2
quercetin (food supplement)
|
1000 mg quercetin within 24 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
antioxidant status after 24 hours
Time Frame: 24 hours
|
24 hours
|
|
inflammatory status after 24 hours
Time Frame: 24 hours
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
plasma quercetin concentration after 24 hours
Time Frame: 24 hours
|
24 hours
|
|
plasma malondialdehyde (MDA) levels after 24 hours
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
Investigators
- Study Chair: Aalt Bast, PhD, Maastricht University
- Principal Investigator: Agnes W Boots, PhD, Maastricht University
- Study Director: Guido R Haenen, PhD, Maastricht University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEC 05.142.5
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