SarcoidosisNCT00402623
The Effect of Quercetin in Sarcoidosis
A study testing quercetin in people with Sarcoidosis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- quercetin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2006to Jan 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- clinical diagnosis of sarcoidosis with emphasize on pulmonary sarcoidosis
- no smoking
- no treatment
Who cannot join
- clinical diagnosis (and treatment) of other diseases
- symptoms of sarcoidosis in other organs besides the lung
- use of food supplements or vitamins
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sarcoidosis
- Being tested
- quercetin, placebo
- Keywords
- sarcoidosis, quercetin, supplementation, oxidative stress, inflammation
- Medical subject headings
- Sarcoidosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quercetinDietary supplement
1000 mg quercetin within 24 hours
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | placebo Receives: Other: placebo |
| 2 | Active comparator | quercetin (food supplement) Receives: Dietary Supplement: quercetin |
What is being measured
The primary outcome is the main question the study is designed to answer.
antioxidant status after 24 hours
Measured: 24 hours
inflammatory status after 24 hours
Measured: 24 hours
Secondary outcomes (2)
plasma quercetin concentration after 24 hours
Measured: 24 hours
plasma malondialdehyde (MDA) levels after 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startJan 2006
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Aalt Bast, PhD, Study chair, Maastricht UniversityAgnes W Boots, PhD, Principal investigator, Maastricht UniversityGuido R Haenen, PhD, Study director, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402623
- Sponsor's protocol ID
- MEC 05.142.5
- Status last verified
- Feb 2008
- First submitted
- 20 Nov 2006
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21324570
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Quercetin on the Increased Inflammatory and Decreased Antioxidant Status in Sarcoidosis
- ClinicalTrials.gov ID
- NCT00402623
- Acronym / sponsor ID
- MEC 05.142.5
- Conditions
- Sarcoidosis
- Keywords
- sarcoidosis, quercetin, supplementation, oxidative stress, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Jan 2006
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 22 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: placeboplacebo |
| 2 | Active comparator | Dietary Supplement: quercetinquercetin (food supplement) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis of sarcoidosis with emphasize on pulmonary sarcoidosis
- no smoking
- no treatment
Key exclusion criteria (3 listed)
- clinical diagnosis (and treatment) of other diseases
- symptoms of sarcoidosis in other organs besides the lung
- use of food supplements or vitamins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quercetin1000 mg quercetin within 24 hours | Dietary supplement | 2 |
| placebo | Other | 1 |
Primary outcome
antioxidant status after 24 hours
Time frame: 24 hours
inflammatory status after 24 hours
Time frame: 24 hours
2 secondary outcomes
plasma quercetin concentration after 24 hours
Time frame: 24 hours
plasma malondialdehyde (MDA) levels after 24 hours
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Derived from this study: PubMed 21324570Boots 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aalt Bast, PhD study chair
Maastricht University
Agnes W Boots, PhD principal investigator
Maastricht University
Guido R Haenen, PhD study director
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quercetin in people with Sarcoidosis, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
antioxidant status after 24 hours (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00402623, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017.