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The Effect of Quercetin in Sarcoidosis

Primary Purpose

Sarcoidosis

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
quercetin
placebo
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoidosis focused on measuring sarcoidosis, quercetin, supplementation, oxidative stress, inflammation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2

Arm Description

placebo

quercetin (food supplement)

Outcomes

Primary Outcome Measures

antioxidant status after 24 hours
inflammatory status after 24 hours

Secondary Outcome Measures

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

Full Information

First Posted
November 20, 2006
Last Updated
February 22, 2017
Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00402623
Brief Title
The Effect of Quercetin in Sarcoidosis
Official Title
The Effect of Quercetin on the Increased Inflammatory and Decreased Antioxidant Status in Sarcoidosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis
Keywords
sarcoidosis, quercetin, supplementation, oxidative stress, inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
2
Arm Type
Active Comparator
Arm Description
quercetin (food supplement)
Intervention Type
Dietary Supplement
Intervention Name(s)
quercetin
Intervention Description
1000 mg quercetin within 24 hours
Intervention Type
Other
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
antioxidant status after 24 hours
Time Frame
24 hours
Title
inflammatory status after 24 hours
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
plasma quercetin concentration after 24 hours
Time Frame
24 hours
Title
plasma malondialdehyde (MDA) levels after 24 hours
Time Frame
24 hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aalt Bast, PhD
Organizational Affiliation
Maastricht University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Agnes W Boots, PhD
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guido R Haenen, PhD
Organizational Affiliation
Maastricht University
Official's Role
Study Director
Facility Information:
Facility Name
Maastricht University
City
Maastricht
ZIP/Postal Code
6200 MD
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
21324570
Citation
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. doi: 10.1016/j.clnu.2011.01.010. Epub 2011 Feb 15.
Results Reference
derived

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The Effect of Quercetin in Sarcoidosis

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