NCT00402623

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2008

Enrollment Period

Same day

First QC Date

November 20, 2006

Last Update Submit

February 22, 2017

Conditions

Sarcoidosis

Keywords

sarcoidosisquercetinsupplementationoxidative stressinflammation

Outcome Measures

Primary Outcomes (2)

  • antioxidant status after 24 hours

    24 hours

  • inflammatory status after 24 hours

    24 hours

Secondary Outcomes (2)

  • plasma quercetin concentration after 24 hours

    24 hours

  • plasma malondialdehyde (MDA) levels after 24 hours

    24 hours

Study Arms (2)

1

PLACEBO COMPARATOR

placebo

Other: placebo

2

ACTIVE COMPARATOR

quercetin (food supplement)

Dietary Supplement: quercetin

Interventions

quercetinDIETARY_SUPPLEMENT

1000 mg quercetin within 24 hours

2
placeboOTHER
1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, 6200 MD, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 21324570DERIVED

MeSH Terms

Conditions

SarcoidosisInflammation

Interventions

Quercetin

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FlavonolsFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Aalt Bast, PhD

    Maastricht University

    STUDY CHAIR

  • Agnes W Boots, PhD

    Maastricht University

    PRINCIPAL INVESTIGATOR

  • Guido R Haenen, PhD

    Maastricht University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 20, 2006

First Posted

November 22, 2006

Study Start

January 1, 2006

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

February 24, 2017

Record last verified: 2008-02

Locations

NL(1)