FlushingPhase 4NCT03370848
Effects of Psyllium on Niacin Tolerability
A Phase 4 study testing Psyllium and Aspirin in people with Flushing and Hyperlipidemias, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
Trial summary
The purpose of this study is to determine whether psyllium is effective in reducing flushing due to niacin and also to measure the effect of niacin on cholesterol levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Flushing, Hyperlipidemias, Dyslipidemias
- What is being tested?
- Psyllium and Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jul 2011
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are starting ER niacin for clinical indication by a healthcare provider
- No prior use of psyllium for the past 2 months
- No prior use of niacin for the past 3 months
- Ability to give informed consent
- Must be reachable by telephone
Who cannot join
- Known contraindications to ER niacin, aspirin or psyllium (including: presence of nausea, vomiting, abdominal pain, intestinal obstruction, or fecal impaction; known hypersensitivity to ER niacin, aspirin or psyllium; severe hepatic dysfunction, transaminitis; history of gastrointestinal bleed attributable to aspirin induced gastritis)
- Patient who are unable to perform assessment of flushing using the standardized scales or questionnaires
- Patients who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
VA West Los Angeles Medical Center
Los Angeles, California, 90073
About this study
Official title: A Prospective Randomized, Open-Label, Crossover Study on the Effects of Psyllium on Niacin Tolerability
The purpose of this study is to determine whether psyllium is effective in reducing flushing due to niacin and also to measure the effect of niacin on cholesterol levels.
- Conditions
- Flushing, Hyperlipidemias, Dyslipidemias
- Being tested
- Psyllium, Aspirin
- Keywords
- Niacin, Psyllium, Dietary fiber
- Medical subject headings
- Flushing, Hyperlipidemias, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsylliumDietary supplement
Also called Metamucil, Cilium, Fiberall
Aspirin 325 mg tablet and two 1.7gm psyllium wafers (3.4gm total) 30 minutes prior to niacin ER
AspirinDrug
Also called Bayer, Ecotrin
Aspirin 325 mg tablet 30 minutes prior to niacin ER
| Study group | Role | What they receive |
|---|---|---|
| Psyllium plus Aspirin and Niacin ER | Experimental | Niacin ER 500mg tablet - take 1 niacin ER 500mg tablet at least two hours before bedtime for two weeks, then increase niacin ER to two 500mg tablets (1,000 mg total) for two weeks, then increase to three niacin ER 500mg tablets (1,500 mg total) for two weeks.
Aspirin 325mg tablet - take 1 aspirin 325 mg tablet 30 minutes prior to niacin ER
Psyllium 1.7gm wafers - take 2 wafers (3.4 grams total) along with aspirin 30 minutes prior to niacin ER Receives: Dietary Supplement: Psyllium; Drug: Aspirin |
| Aspirin and Niacin ER | Active comparator | Niacin ER 500mg tablet - take 1 niacin ER 500mg tablet at least two hours before bedtime for two weeks, then increase niacin ER to two 500mg tablets (1,000 mg total) for two weeks, then increase to three niacin ER 500mg tablets (1,500 mg total) for two weeks.
Aspirin 325mg tablet - take 1 aspirin 325 mg tablet 30 minutes prior to niacin ER Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Flushing Severity Score
Measured: up to 6 weeks
Secondary outcomes (2)
HDL
Measured: Baseline, & end of week 6
LDL
Measured: Baseline, & end of week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study startMar 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FlushingStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Greater Los Angeles Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Freny V Mody, MD, Principal investigator, VA Greater Los Angeles Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370848
- Sponsor's protocol ID
- 039
- Status last verified
- Dec 2017
- First submitted
- 20 Dec 2016
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized, Open-Label, Crossover Study on the Effects of Psyllium on Niacin Tolerability
- ClinicalTrials.gov ID
- NCT03370848
- Acronym / sponsor ID
- 039
- Conditions
- Flushing, Hyperlipidemias, Dyslipidemias
- Keywords
- Niacin, Psyllium, Dietary fiber
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- VA Greater Los Angeles Healthcare SystemUS federal agency
- Study start
- Mar 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 12 Dec 2017 (actual)
- 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 purpose of this study is to determine whether psyllium is effective in reducing flushing due to niacin and also to measure the effect of niacin on cholesterol levels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psyllium plus Aspirin and Niacin ER | Experimental | Dietary Supplement: Psyllium, Drug: AspirinNiacin ER 500mg tablet - take 1 niacin ER 500mg tablet at least two hours before bedtime for two weeks, then increase niacin ER to two 500mg tablets (1,000 mg total) for two weeks, then increase to three niacin ER 500mg tablets (1,500 mg total) for two weeks. Aspirin 325mg tablet - take 1 aspirin 325 mg tablet 30 minutes prior to niacin ER Psyllium 1.7gm wafers - take 2 wafers (3.4 grams total) along with aspirin 30 minutes prior to niacin ER |
| Aspirin and Niacin ER | Active comparator | Drug: AspirinNiacin ER 500mg tablet - take 1 niacin ER 500mg tablet at least two hours before bedtime for two weeks, then increase niacin ER to two 500mg tablets (1,000 mg total) for two weeks, then increase to three niacin ER 500mg tablets (1,500 mg total) for two weeks. Aspirin 325mg tablet - take 1 aspirin 325 mg tablet 30 minutes prior to niacin ER |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who are starting ER niacin for clinical indication by a healthcare provider
- No prior use of psyllium for the past 2 months
- No prior use of niacin for the past 3 months
- Ability to give informed consent
- Must be reachable by telephone
Key exclusion criteria (3 listed)
- Known contraindications to ER niacin, aspirin or psyllium (including: presence of nausea, vomiting, abdominal pain, intestinal obstruction, or fecal impaction; known hypersensitivity to ER niacin, aspirin or psyllium; severe hepatic dysfunction, transaminitis; history of gastrointestinal bleed attributable to aspirin induced gastritis)
- Patient who are unable to perform assessment of flushing using the standardized scales or questionnaires
- Patients who are pregnant
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 |
|---|---|---|
| PsylliumAlso: Metamucil, Cilium, FiberallAspirin 325 mg tablet and two 1.7gm psyllium wafers (3.4gm total) 30 minutes prior to niacin ER | Dietary supplement | Psyllium plus Aspirin and Niacin ER |
| AspirinAlso: Bayer, EcotrinAspirin 325 mg tablet 30 minutes prior to niacin ER | Drug | Aspirin and Niacin ER, Psyllium plus Aspirin and Niacin ER |
Primary outcome
Global Flushing Severity Score
Time frame: up to 6 weeks
2 secondary outcomes
HDL
Time frame: Baseline, & end of week 6
LDL
Time frame: Baseline, & end of week 6
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 12 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Freny V Mody, MD principal investigator
VA Greater Los Angeles Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Psyllium and Aspirin in people with Flushing and Hyperlipidemias, run by VA Greater Los Angeles Healthcare System 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 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 12 Dec 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 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. 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?
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?
Global Flushing Severity Score (time frame: up to 6 weeks). 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 12 Dec 2017.