Biosynthesis of PGD2 in Vivo

NCT ID: NCT01275300

Last Updated: 2026-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2012-01-31

Brief Summary

The investigator would like to see if aspirin could block niacin-induced flushing by analyzing blood and urine after taking aspirin.

Phase I: Subjects were assigned to either placebo or aspirin groups. They were given 5 days of 81 mg aspirin or placebo. On day 5, they were given a single dose of niacin (600 mg) administered 30 minutes after the last dose of aspirin or placebo. The same subjects came back for cross-over study and were assigned to a different group. There was a 2-week washout period between each treatment. Urine was collected sequentially for analysis

Phase II: The same study subjects come back for an open label one week study. They were given 5 days of taking 81 mg Aspirin, taken once daily, followed by a single dose of 600 mg Niacin on day 6. Urine was collected sequentially for analysis

Detailed Description

The purpose of this study is to look at the roles of various blood cells and their contributions of different prostaglandins. The intention is that by better understanding these prostaglandins and various metabolites, it will provide insights into their roles in the cardiovascular system.

Prostaglandins and metabolites are naturally occurring substances found in the blood and urine which can act as markers which can be quantified and studied as we will be doing in this study. Flushing response to niacin will also be assessed by laser doppler measuring blood flow of the facial skin.

Untransformed and transformed data will be subjected to exploratory analysis of variance appropriated for a three factor design with one two period crossover factor and two non-repeated factors. Additionally, volunteer's test(s) for paired observations will characterize the magnitude of the niacin effect on the response variables within selected time points.

Conditions

Hyperlipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo phase I

Subjects were given 5 days of placebo. On day 5, they were given a single dose of niacin (600 mg) administered 30 minutes after the last dose of placebo. Urine was collected sequentially for analysis. The same subjects came back for cross-over study and were assigned to Aspirin group. There was a 2-week washout period between each treatment.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Niacin

Intervention Type: DRUG

Aspirin phase I

Subjects were given 5 days of 81 mg aspirin. On day 5, they were given a single dose of niacin (600 mg) administered 30 minutes after the last dose of aspirin or placebo. Urine was collected sequentially for analysis.

Group Type: ACTIVE_COMPARATOR

Aspirin

Intervention Type: DRUG

Niacin

Intervention Type: DRUG

Aspirin phase II

In phase II study, subjects were given 5 days of 81 mg aspirin. On day 6, they were given a single dose of niacin (600 mg) administered 24 hours after the last dose of aspirin. Urine was collected sequentially for analysis

Group Type: ACTIVE_COMPARATOR

Aspirin

Intervention Type: DRUG

Niacin

Intervention Type: DRUG

Interventions

Aspirin

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Niacin

Intervention Type: DRUG

Other Intervention Names

Aspirin 81 mg; Niacin 600 mg

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wenliang Song, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Garret FitzGerald, MD

Role: STUDY_CHAIR

University of Pennsylvania

Locations

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

References

Song WL, Stubbe J, Ricciotti E, Alamuddin N, Ibrahim S, Crichton I, Prempeh M, Lawson JA, Wilensky RL, Rasmussen LM, Pure E, FitzGerald GA. Niacin and biosynthesis of PGD(2)by platelet COX-1 in mice and humans. J Clin Invest. 2012 Apr;122(4):1459-68. doi: 10.1172/JCI59262. Epub 2012 Mar 12.

Reference Type: RESULT

PMID: 22406532 (View on PubMed)

Related Links

http://www.jci.org/articles/view/59262/cite

Niacin and biosynthesis of PGD2 by platelet COX-1 in mice and humans

Other Identifiers

806115 - FitzGerald, MD

Identifier Type: -

Identifier Source: org_study_id