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Aspirin may block Niacin's uncomfortable flush, tiny study hints

NCT ID NCT01275300

Knowledge-focused Sponsor: University of Pennsylvania Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested whether taking a low dose of aspirin (81 mg) before niacin (600 mg) could reduce the flushing reaction that niacin often causes. Nine healthy adults with high cholesterol participated, providing urine and blood samples to measure prostaglandin levels. The study was small and exploratory, aiming to understand the body's response rather than prove a treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Aspirin 81 mg and Niacin 600 mg
What this could lead to
If successful, this could help understand how to reduce the uncomfortable flushing side effect of niacin, potentially making it easier for people with high cholesterol to tolerate the medication.
What could go wrong
This is a very small pilot study with only 9 participants, so results may not apply to the general population. It is designed to measure biological markers, not to prove any treatment benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

9 people

The number who actually took part.

Start date

Jul 2007

Finished

Jan 2012

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: age between 18-70 * subject must be in good health as based on medical history * All subjects must be non-smoking, non-pregnant volunteers * Female subjects of child bearing potential must be using a medically acceptable method of contraception throughout the entire study period. All female subjects must consent to a urine pregnancy test at screening and just prior to the start of each treatment period of the study, which must be negative at all time points. Exclusion Criteria: * subjects with any medical condition that according to the investigator may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject. * subjects who have received an experimental drug within 30 days prior to the study. * subjects who have taken medications at least 10 days prior to the study. Birth Control pills are acceptable and shall not be excluded. * Subjects who have taken aspirin or aspirin containing products for at least 10 days prior to the study. * Subjects who have taken acetaminophen, NSAIDS, COX-2 inhibitors (OTC or prescription) for at least 10 days prior to the study. * Subjects who are currently consuming any type of tobacco product(s). * Subjects who consume high doses of antioxidant vitamins daily (vitamin C \> 1000mg, Vitamin E \> 400 IU, Beta Carotene \> 1000IU, Vitamin A \> 5000IU, Selenium \> 200mcg, Folic Acid \> 1mg) for the 2 weeks prior to the start of the study and throughout the study. * Subjects who consume alcohol, caffeine or high fat food 24 hours prior to study.

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Conditions

The condition(s) this trial relates to.

hyperlipidemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hyperlipidemia

Contacts and locations

Locations

  • University of Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19104, United States

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