HypercholesterolemiaNCT00895193
Alternative Options to Minimize Niacin-Induced Flushing
A study testing Apple pectin and Aspirin 325 mg in people with Hypercholesterolemia and Flushing, run by Patrick Moriarty, MD, FACP, FACC at 1 site in United States.
Trial summary
Niacin (Vitamin B3) is known to effectively and safely treat hypercholesterolemia. However, use of niacin is limited due to incidents of flushing which limits its acceptability. Some information suggests that applesauce can reduce the incidence and severity of flushing. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Hypercholesterolemia, Flushing
- What is being tested?
- Apple pectin and Aspirin 325 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2010
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An adult between 21 and 70 years of age.
- Male or female (If female must be postmenopausal for at least 1 year, surgically sterile or using an effective form of contraception).
- Able to speak and read English.
- Willing to comply with study specific instructions, and complete all study procedures according to protocol.
- Able to understand study rationale and sign informed consent.
Who cannot join
- Females of child-bearing potential not using acceptable method of contraception and perimenopausal females.
- History of gout
- History of diabetes mellitus
- History of coronary heart disease
- History of, or currently experiencing, renal disease including, but not limited to, renal insufficiency, nephrolithiasis or chronic renal failure.
- History of, or currently experiencing, major chronic gastrointestinal condition including gallbladder disease, liver disease and peptic ulcer disease
Show all 13Show fewer
- Known sensitivity to niacin, Aspirin or nonsteroidal anti-inflammatory agents (NSAIDs)
- History of migraine or cluster headaches
- Currently using antihistamines, aspirin or NSAIDS on a consistent basis
- Presence or history of any medical or psychosocial condition that, in the opinion of the investigator, would limit the patient's successful participation or would compromise the patient's safe participation.
- Lab abnormalities at screening, including but not limited to elevated liver enzymes or blood sugar levels that might indicate additional risk to the patient's continued participation.
- Currently taking medication that might be contraindicated with the study drug or Niacin or study procedures (including Niacin, lipid-lowering drugs, chronic aspirin or laxative use).
- Clinically significant finding from physical exam that would affect the patient's safe participation or completion of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Niacin (Vitamin B3) is known to effectively and safely treat hypercholesterolemia. However, use of niacin is limited due to incidents of flushing which limits its acceptability. Some information suggests that applesauce can reduce the incidence and severity of flushing. The apple pectin in particular is thought to be the ingredient that affects this reaction. To determine if the apple pectin does affect flushing from niacin, the investigators will study the affects of isolated apple pectin in pill form. The investigators plan on recruiting 100 patients, and giving them 1000 mg of Niacin to induce flushing. Patients will be divided into 4 treatment groups and receive either pectin, aspirin, a combination of both, or placebo. Incidents and severity of flushing will be monitored for up to 6 hours post Niacin ingestion.
- Conditions
- Hypercholesterolemia, Flushing
- Being tested
- Apple pectin, Aspirin 325 mg, Placebo
- Keywords
- Niacin, Hypercholesterolemia, Flushing
- Medical subject headings
- Hypercholesterolemia, Flushing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple pectinOther
Apple pectin 2000mg
Aspirin 325 mgDrug
Aspirin 325 mg
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Apple-pectin 2000mg | Active comparator | Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. Receives: Other: Apple pectin |
| Regular Non-enteric coated aspirin 325mg | Active comparator | Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. Receives: Drug: Aspirin 325 mg |
| Apple pectin + aspirin | Active comparator | Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. Receives: Other: Apple pectin; Drug: Aspirin 325 mg |
| Placebo Comparator | Placebo comparator | Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Flushing
Flushing assessment performed hourly for 6 hours after niacin administration. Incidence of flushing based on if the participant experience any niacin-induced flushing during the 6 hour period after dosing. Represents # of participants that experienced event.
Measured: Hourly for 6 hours on day of dosing
Time to Flushing
The time it took, in minutes, for a participant to experience any flushing. Time to flush for individuals that did not experience flushing within 6 hours was set to 360 minutes.
Measured: 6 hours after dosing
Duration of Flushing
The amount of time, in minutes, that flushing lasted. Duration of individuals without experience flushing within 6 hours was set to 0 minutes.
Measured: 6 hours after dosing
Maximum Flushing Severity Score
Flushing assessment performed hourly for six hours. Assessment of severity done using the validated visual analog scale (VAS) flushing assessment tool (FAST). Severity rated using a VAS from mild (1-3), moderate (4-6), severe (7-9) to very severe (10). The maximum severity score was the maximum severity score of each individual during the 6 hours of monitoring time period.
Measured: 6 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionDec 2010
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 HypercholesterolemiaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patrick Moriarty, MD, FACP, FACC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Patrick Moriarty, MD, FACP, FACC, University of Kansas Medical Center
- Investigators
- Patrick Moriarty, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895193
- Sponsor's protocol ID
- 11627
- Status last verified
- May 2014
- First submitted
- 6 May 2009
- Last updated
- 5 Jun 2014
- 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 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternative Options to Minimize Niacin-Induced Flushing
- ClinicalTrials.gov ID
- NCT00895193
- Acronym / sponsor ID
- 11627
- Conditions
- Hypercholesterolemia, Flushing
- Keywords
- Niacin, Hypercholesterolemia, Flushing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Patrick Moriarty, MD, FACP, FACCUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 8 May 2009 (estimated)
- Results
- Posted 17 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Niacin (Vitamin B3) is known to effectively and safely treat hypercholesterolemia. However, use of niacin is limited due to incidents of flushing which limits its acceptability. Some information suggests that applesauce can reduce the incidence and severity of flushing. The apple pectin in particular is thought to be the ingredient that affects this reaction. To determine if the apple pectin does affect flushing from niacin, the investigators will study the affects of isolated apple pectin in pill form. The investigators plan on recruiting 100 patients, and giving them 1000 mg of Niacin to induce flushing. Patients will be divided into 4 treatment groups and receive either pectin, aspirin, a combination of both, or placebo. Incidents and severity of flushing will be monitored for up to 6 hours post Niacin ingestion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Apple-pectin 2000mg | Active comparator | Other: Apple pectinParticipant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. |
| Regular Non-enteric coated aspirin 325mg | Active comparator | Drug: Aspirin 325 mgParticipant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. |
| Apple pectin + aspirin | Active comparator | Other: Apple pectin, Drug: Aspirin 325 mgParticipant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin. |
| Placebo Comparator | Placebo comparator | Other: PlaceboParticipant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- An adult between 21 and 70 years of age.
- Male or female (If female must be postmenopausal for at least 1 year, surgically sterile or using an effective form of contraception).
- Able to speak and read English.
- Willing to comply with study specific instructions, and complete all study procedures according to protocol.
- Able to understand study rationale and sign informed consent.
Key exclusion criteria (13 listed)
- Females of child-bearing potential not using acceptable method of contraception and perimenopausal females.
- History of gout
- History of diabetes mellitus
- History of coronary heart disease
- History of, or currently experiencing, renal disease including, but not limited to, renal insufficiency, nephrolithiasis or chronic renal failure.
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 |
|---|---|---|
| Apple pectinApple pectin 2000mg | Other | Apple pectin + aspirin, Apple-pectin 2000mg |
| Aspirin 325 mgAspirin 325 mg | Drug | Apple pectin + aspirin, Regular Non-enteric coated aspirin 325mg |
| PlaceboPlacebo | Other | Placebo Comparator |
Primary outcome
Incidence of Flushing
Time frame: Hourly for 6 hours on day of dosing
Flushing assessment performed hourly for 6 hours after niacin administration. Incidence of flushing based on if the participant experience any niacin-induced flushing during the 6 hour period after dosing. Represents # of participants that experienced event.
Time to Flushing
Time frame: 6 hours after dosing
The time it took, in minutes, for a participant to experience any flushing. Time to flush for individuals that did not experience flushing within 6 hours was set to 360 minutes.
Duration of Flushing
Time frame: 6 hours after dosing
The amount of time, in minutes, that flushing lasted. Duration of individuals without experience flushing within 6 hours was set to 0 minutes.
Maximum Flushing Severity Score
Time frame: 6 hours after dosing
Flushing assessment performed hourly for six hours. Assessment of severity done using the validated visual analog scale (VAS) flushing assessment tool (FAST). Severity rated using a VAS from mild (1-3), moderate (4-6), severe (7-9) to very severe (10). The maximum severity score was the maximum severity score of each individual during the 6 hours of monitoring time period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2014.
- 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.
Patrick Moriarty, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apple pectin and Aspirin 325 mg in people with Hypercholesterolemia and Flushing, run by Patrick Moriarty, MD, FACP, FACC at 1 site 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 5 inclusion and 13 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 Jun 2014. 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2014). 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?
Incidence of Flushing (time frame: Hourly for 6 hours on day of dosing). The study lists 4 primary outcomes in all. 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 Jun 2014.