Biosynthesis of PGD2 in Vivo
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| ClinicalTrials.gov Identifier: NCT01275300 |
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Recruitment Status :
Completed
First Posted : January 12, 2011
Results First Posted : July 9, 2020
Last Update Posted : June 23, 2021
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hyperlipidemia | Drug: Aspirin Drug: Placebo Drug: Niacin | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 9 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Basic Science |
| Official Title: | A Pilot Study to Measure Plasma and Urinary Prostaglandin D2 Metabolites Evoked by Niacin |
| Study Start Date : | July 2007 |
| Actual Primary Completion Date : | January 2012 |
| Actual Study Completion Date : | January 2012 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: 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.
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Drug: Placebo Drug: Niacin Other Name: Niacin 600 mg |
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Active Comparator: 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.
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Drug: Aspirin
Other Name: Aspirin 81 mg Drug: Niacin Other Name: Niacin 600 mg |
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Active Comparator: 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
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Drug: Aspirin
Other Name: Aspirin 81 mg Drug: Niacin Other Name: Niacin 600 mg |
- Percentage Change of Area Under Curve for the Urinary Prostaglandins Concentration Versus Time Curve (AUC) in Response to Aspirin or Placebo [ Time Frame: -2-0, 0-2, 2-4, 4-6, 6-12 and 12-24 hours pre or post niacin ]Percentage change of area under the urinary prostaglandins concentration versus time curve (AUC) in response to niacin with or without pretreatment of aspirin was studied. This outcome measures whether aspirin instead of placebo will impact the subjects' response to niacin. The area was normalized by percentile.
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01275300
| United States, Pennsylvania | |
| University of Pennsylvania Hospital | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Wenliang Song, MD | University of Pennsylvania | |
| Study Chair: | Garret FitzGerald, MD | University of Pennsylvania |
Publications of Results:
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01275300 |
| Other Study ID Numbers: |
806115 - FitzGerald, MD |
| First Posted: | January 12, 2011 Key Record Dates |
| Results First Posted: | July 9, 2020 |
| Last Update Posted: | June 23, 2021 |
| Last Verified: | June 2021 |
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Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Aspirin Niacin Niacinamide Nicotinic Acids Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents |
Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Hypolipidemic Agents Antimetabolites Lipid Regulating Agents Vasodilator Agents Vitamin B Complex Vitamins Micronutrients |