NCT00512967

Brief Summary

Reactive oxygen species (ROS) are suggested to play a pivotal role in ILD. Little is known, however, about the endogenous antioxidant levels in ILD that can offer protection against ROS. It is expected that the high amount of ROS present in ILD will reduce the antioxidant levels. Therefore, antioxidant therapy to strengthen this reduced antioxidant defense might be efficacious in ILD treatment. Since ROS are capable of initiating and mediating inflammation, antioxidant therapy might also mitigate elevated inflammation. A candidate for antioxidant therapy is the flavonoid quercetin that is known for its anti-oxidative and anti-inflammatory capacities. The aim of the present study is to determine the antioxidant and inflammatory status in ILD, i.e. sarcoidosis and idiopathic pulmonary fibrosis (IPF). Furthermore, to evaluate the possible anti-inflammatory effects of antioxidants, the effect of quercetin will be examined on the ex vivo LPS-induced cytokine production in ILD

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2005

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2007

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 8, 2007

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2008

First QC Date

July 19, 2007

Last Update Submit

February 22, 2017

Conditions

Keywords

oxidative stressantioxidantsinflammationquercetin

Study Arms (4)

sarcoidosis

21 onset patients, non-treated

IPF

15 IPF patients, partially treated

COPD

15 COPD patients within 24 hours after their last exacerbation

controls

25 healthy controls, matched for age and gender

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

lung patients visiting the out-patient clinic of the Academic Hospital Maastricht

You may qualify if:

  • clinical diagnosis of pulmonary sarcoidosis, IPF or COPD
  • no treatment for sarcoidosis
  • last exacerbation not more than 24 hours ago for COPD
  • healthy controls
  • no smoking for sarcoidosis and IPF

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, 6224 LH, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples were collected

MeSH Terms

Conditions

Lung Diseases, InterstitialSarcoidosisIdiopathic Pulmonary FibrosisPulmonary Disease, Chronic ObstructiveInflammation

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesPulmonary FibrosisLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 19, 2007

First Posted

August 8, 2007

Study Start

September 1, 2005

Study Completion

June 1, 2006

Last Updated

February 24, 2017

Record last verified: 2008-02

Locations