FlushingPhase 4ANTI-FLUSHNCT00913081
Advancing Niacin by Inhibiting Flushing (ANTI-FLUSH)
A Phase 4 study testing Quercetin in people with Flushing, run by University of Pennsylvania at 2 sites in United States.
Trial summary
Niacin, or vitamin B3, is known to improve cholesterol disorders and is the most effective drug to raise HDL, or the "good cholesterol". The use of niacin has been limited because of a peculiar adverse effect referred to as "flushing', which consists of redness, warmth, tingling and burning. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Flushing
- What is being tested?
- Quercetin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2009to Dec 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women from the age of 21 to 75, inclusive - 16 subjects, 8 men, 8 women.
- Ability to understand and agree to informed consent.
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
Who cannot join
- Contra-indications or known intolerance to the study medications.
- History of congestive heart failure, carcinoid, rosacea, renal failure (GFR<60 ml/min/m2).
- Active liver disease.
- Active diabetes (defined as any history of type 1 diabetes, or history of type 2 diabetes plus one or more of the following: fasting glucose>= 126mg/dL at screening or use of anti-diabetic medications within 12 months, or glucose>200mg/dL 2 hours after a 75 g oral glucose challenge within 12 months.
- History of major surgery within the past 6 weeks, or anticipated major surgery during the course of the study, or any history of organ transplant.
- History of drug abuse within the past 3 years, or regular alcohol use of greater than 14 drinks per week.
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- Women who are pregnant, plan to conceive or lactate.
- Peri-menopausal women or women currently experiencing flushing.
- Currently taking vasoactive medications, anti-hypertensives, anti-histamines, Selective Serotonin Re-uptake Inhibitors (SSRIs), NSAIDS, oral steroids, leukotriene inhibitors, supplemental quercetin and > 50mg niacin.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CTRC Univ. of Penn - Andrew Mutch Bldg., 4th floor
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Advancing Niacin by Inhibiting FLUSHing: (ANTI-FLUSH)
Niacin, or vitamin B3, is known to improve cholesterol disorders and is the most effective drug to raise HDL, or the "good cholesterol". The use of niacin has been limited because of a peculiar adverse effect referred to as "flushing', which consists of redness, warmth, tingling and burning. A recent animal study suggests that flavonoids may prevent flushing due to niacin better than drugs like aspirin. The ANTI-FLUSH study is being done to assess whether a presently available dietary supplement known as quercetin, which is a flavonoid, can reduce the flushing that occurs with niacin. We will also assess whether using quercetin to prevent flushing from niacin, can improve how niacin lowers cholesterol.
Read the detailed description
This study involves people between 21 and 75 years. It will be conducted over a period of 8 weeks, with 4 visits, each separated by 2 weeks. The duration of each visit is 9-10 hours. We will test a different dose of quercetin in each visit.
- Conditions
- Flushing
- Being tested
- Quercetin, Placebo
- Keywords
- Skin, pharmacology, metabolism, lipid
- Medical subject headings
- Flushing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuercetinDietary supplement
Also called Isoquercetin
Quercetin 500, 1000, or 2000 mg PO one time
PlaceboDietary supplement
Placebo PO one time
| Study group | Role | What they receive |
|---|---|---|
| Quercetin 500 mg | Experimental | Quercetin 500 mg once, administered one hour before 500 mg immediate-release niacin Receives: Dietary Supplement: Quercetin |
| Quercetin 1000 mg | Experimental | Quercetin 1000 mg once, administered one hour before 500 mg immediate-release niacin Receives: Dietary Supplement: Quercetin |
| Quercetin 2000 mg | Experimental | Quercetin 2000 mg once, administered one hour before 500 mg immediate-release niacin Receives: Dietary Supplement: Quercetin |
| Placebo | Placebo comparator | Placebo once, administered one hour before 500 mg immediate-release niacin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether Quercetin Dose-dependently Reduces Laser Doppler Flux Index Primary Peak Following Immediate-release Niacin
Laser Doppler flowmetry at the malar eminence measures blood flow quantitatively as red blood cell flux. Flux index is the fold-change in flux over baseline. Flux index primary peak is the maximum flux index between 0-4 hours after niacin.
Measured: 8 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FlushingStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Richard L. Dunbar, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913081
- Sponsor's protocol ID
- IRB #808911
- Acronym
- ANTI-FLUSH
- Status last verified
- Nov 2011
- First submitted
- 29 May 2009
- Last updated
- 5 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Niacin by Inhibiting FLUSHing: (ANTI-FLUSH)
- ClinicalTrials.gov ID
- NCT00913081
- Acronym / sponsor ID
- ANTI-FLUSH / IRB #808911
- Conditions
- Flushing
- Keywords
- Skin, pharmacology, metabolism, lipid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Feb 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Posted 5 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Niacin, or vitamin B3, is known to improve cholesterol disorders and is the most effective drug to raise HDL, or the "good cholesterol". The use of niacin has been limited because of a peculiar adverse effect referred to as "flushing', which consists of redness, warmth, tingling and burning. A recent animal study suggests that flavonoids may prevent flushing due to niacin better than drugs like aspirin. The ANTI-FLUSH study is being done to assess whether a presently available dietary supplement known as quercetin, which is a flavonoid, can reduce the flushing that occurs with niacin. We will also assess whether using quercetin to prevent flushing from niacin, can improve how niacin lowers cholesterol.
Detailed description
This study involves people between 21 and 75 years. It will be conducted over a period of 8 weeks, with 4 visits, each separated by 2 weeks. The duration of each visit is 9-10 hours. We will test a different dose of quercetin in each visit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Quercetin 500 mg | Experimental | Dietary Supplement: QuercetinQuercetin 500 mg once, administered one hour before 500 mg immediate-release niacin |
| Quercetin 1000 mg | Experimental | Dietary Supplement: QuercetinQuercetin 1000 mg once, administered one hour before 500 mg immediate-release niacin |
| Quercetin 2000 mg | Experimental | Dietary Supplement: QuercetinQuercetin 2000 mg once, administered one hour before 500 mg immediate-release niacin |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo once, administered one hour before 500 mg immediate-release niacin |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women from the age of 21 to 75, inclusive - 16 subjects, 8 men, 8 women.
- Ability to understand and agree to informed consent.
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
Key exclusion criteria (9 listed)
- Contra-indications or known intolerance to the study medications.
- History of congestive heart failure, carcinoid, rosacea, renal failure (GFR<60 ml/min/m2).
- Active liver disease.
- Active diabetes (defined as any history of type 1 diabetes, or history of type 2 diabetes plus one or more of the following: fasting glucose>= 126mg/dL at screening or use of anti-diabetic medications within 12 months, or glucose>200mg/dL 2 hours after a 75 g oral glucose challenge within 12 months.
- History of major surgery within the past 6 weeks, or anticipated major surgery during the course of the study, or any history of organ transplant.
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 |
|---|---|---|
| QuercetinAlso: IsoquercetinQuercetin 500, 1000, or 2000 mg PO one time | Dietary supplement | Quercetin 1000 mg, Quercetin 2000 mg, Quercetin 500 mg |
| PlaceboPlacebo PO one time | Dietary supplement | Placebo |
Primary outcome
Whether Quercetin Dose-dependently Reduces Laser Doppler Flux Index Primary Peak Following Immediate-release Niacin
Time frame: 8 hour period
Laser Doppler flowmetry at the malar eminence measures blood flow quantitatively as red blood cell flux. Flux index is the fold-change in flux over baseline. Flux index primary peak is the maximum flux index between 0-4 hours after niacin.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard L. Dunbar, MD principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quercetin in people with Flushing, run by University of Pennsylvania at 2 sites in United States.
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 9 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 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Whether Quercetin Dose-dependently Reduces Laser Doppler Flux Index Primary Peak Following Immediate-release Niacin (time frame: 8 hour period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2015.