Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT00895193
Status:
COMPLETED
Last Update Posted:
2014-06-05
First Post:
2009-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Alternative Options to Minimize Niacin-Induced Flushing
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D005483', 'term': 'Flushing'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jdutton@kumc.edu', 'phone': '(913) 588-4064', 'title': 'Julie-Ann Dutton, MS, RD', 'organization': 'University of Kansas Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Limitations include: pilot design, small sample size, short duration of a one-time niacin dose, utilization of only one niacin formulation.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Apple-pectin 2000mg', 'description': 'Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Regular Non-enteric Coated Aspirin 325mg', 'description': 'Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Apple Pectin + Aspirin', 'description': 'Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo Comparator', 'description': 'Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Flushing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apple-pectin 2000mg', 'description': 'Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}, {'id': 'OG001', 'title': 'Regular Non-enteric Coated Aspirin 325mg', 'description': 'Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}, {'id': 'OG002', 'title': 'Apple Pectin + Aspirin', 'description': 'Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}, {'id': 'OG003', 'title': 'Placebo Comparator', 'description': 'Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Hourly for 6 hours on day of dosing', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This was a single-site, randomized trial, 4-arm parallel design trial. Each arm consisted of 25 randomized participants. All participants completed the study.'}, {'type': 'PRIMARY', 'title': 'Time to Flushing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apple-pectin 2000mg', 'description': 'Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}, {'id': 'OG001', 'title': 'Regular Non-enteric Coated Aspirin 325mg', 'description': 'Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}, {'id': 'OG002', 'title': 'Apple Pectin + Aspirin', 'description': 'Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}, {'id': 'OG003', 'title': 'Placebo Comparator', 'description': 'Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.4', 'spread': '51.7', 'groupId': 'OG000'}, {'value': '48.7', 'spread': '33.8', 'groupId': 'OG001'}, {'value': '58.8', 'spread': '42.5', 'groupId': 'OG002'}, {'value': '58.1', 'spread': '66.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 hours after dosing', 'description': '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.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized to the study completed the study. Each arm had 25 participants.'}, {'type': 'PRIMARY', 'title': 'Duration of Flushing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apple-pectin 2000mg', 'description': 'Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}, {'id': 'OG001', 'title': 'Regular Non-enteric Coated Aspirin 325mg', 'description': 'Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}, {'id': 'OG002', 'title': 'Apple Pectin + Aspirin', 'description': 'Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}, {'id': 'OG003', 'title': 'Placebo Comparator', 'description': 'Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.3', 'spread': '35.7', 'groupId': 'OG000'}, {'value': '52.7', 'spread': '53.5', 'groupId': 'OG001'}, {'value': '58.3', 'spread': '40.2', 'groupId': 'OG002'}, {'value': '88', 'spread': '66', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 hours after dosing', 'description': 'The amount of time, in minutes, that flushing lasted. Duration of individuals without experience flushing within 6 hours was set to 0 minutes.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized to the study completed the study. Each arm had 25 participants.'}, {'type': 'PRIMARY', 'title': 'Maximum Flushing Severity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Apple-pectin 2000mg', 'description': 'Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}, {'id': 'OG001', 'title': 'Regular Non-enteric Coated Aspirin 325mg', 'description': 'Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}, {'id': 'OG002', 'title': 'Apple Pectin + Aspirin', 'description': 'Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}, {'id': 'OG003', 'title': 'Placebo Comparator', 'description': 'Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '2.5', 'groupId': 'OG002'}, {'value': '3.6', 'spread': '2.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 hours after dosing', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized to the study completed the study. Each arm had 25 participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Apple-pectin 2000mg', 'description': 'Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}, {'id': 'FG001', 'title': 'Regular Non-enteric Coated Aspirin 325mg', 'description': 'Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}, {'id': 'FG002', 'title': 'Apple Pectin + Aspirin', 'description': 'Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}, {'id': 'FG003', 'title': 'Placebo Comparator', 'description': 'Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Initial screening occurred over the telephone. Subjects that met preliminary study criteria were scheduled for a screening visit. Recruitment was conducted at the University of Kansas Medical Center.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Apple-pectin 2000mg', 'description': 'Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}, {'id': 'BG001', 'title': 'Regular Non-enteric Coated Aspirin 325mg', 'description': 'Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}, {'id': 'BG002', 'title': 'Apple Pectin + Aspirin', 'description': 'Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}, {'id': 'BG003', 'title': 'Placebo Comparator', 'description': 'Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '40', 'spread': '13.3', 'groupId': 'BG001'}, {'value': '40', 'spread': '12.3', 'groupId': 'BG002'}, {'value': '38', 'spread': '12.7', 'groupId': 'BG003'}, {'value': '38.2', 'spread': '12.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '26', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '27', 'spread': '6.2', 'groupId': 'BG001'}, {'value': '26', 'spread': '5.3', 'groupId': 'BG002'}, {'value': '26', 'spread': '5.0', 'groupId': 'BG003'}, {'value': '26.4', 'spread': '5.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist Circumference', 'classes': [{'categories': [{'measurements': [{'value': '35', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '36', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '34', 'spread': '5.0', 'groupId': 'BG002'}, {'value': '35', 'spread': '5.3', 'groupId': 'BG003'}, {'value': '35', 'spread': '5.65', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'inches', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-22', 'studyFirstSubmitDate': '2009-05-06', 'resultsFirstSubmitDate': '2014-02-03', 'studyFirstSubmitQcDate': '2009-05-07', 'lastUpdatePostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-03', 'studyFirstPostDateStruct': {'date': '2009-05-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Flushing', 'timeFrame': 'Hourly for 6 hours on day of dosing', 'description': '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.'}, {'measure': 'Time to Flushing', 'timeFrame': '6 hours after dosing', 'description': '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.'}, {'measure': 'Duration of Flushing', 'timeFrame': '6 hours after dosing', 'description': 'The amount of time, in minutes, that flushing lasted. Duration of individuals without experience flushing within 6 hours was set to 0 minutes.'}, {'measure': 'Maximum Flushing Severity Score', 'timeFrame': '6 hours after dosing', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Niacin', 'Hypercholesterolemia', 'Flushing'], 'conditions': ['Hypercholesterolemia', 'Flushing']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* An adult between 21 and 70 years of age.\n* Male or female (If female must be postmenopausal for at least 1 year, surgically sterile or using an effective form of contraception).\n* Able to speak and read English.\n* Willing to comply with study specific instructions, and complete all study procedures according to protocol.\n* Able to understand study rationale and sign informed consent.\n\nExclusion Criteria:\n\n* Females of child-bearing potential not using acceptable method of contraception and perimenopausal females.\n* History of gout\n* History of diabetes mellitus\n* History of coronary heart disease\n* History of, or currently experiencing, renal disease including, but not limited to, renal insufficiency, nephrolithiasis or chronic renal failure.\n* History of, or currently experiencing, major chronic gastrointestinal condition including gallbladder disease, liver disease and peptic ulcer disease\n* Known sensitivity to niacin, Aspirin or nonsteroidal anti-inflammatory agents (NSAIDs)\n* History of migraine or cluster headaches\n* Currently using antihistamines, aspirin or NSAIDS on a consistent basis\n* 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.\n* 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.\n* 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).\n* Clinically significant finding from physical exam that would affect the patient's safe participation or completion of the study."}, 'identificationModule': {'nctId': 'NCT00895193', 'briefTitle': 'Alternative Options to Minimize Niacin-Induced Flushing', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Alternative Options to Minimize Niacin-Induced Flushing', 'orgStudyIdInfo': {'id': '11627'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Apple-pectin 2000mg', 'description': 'Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.', 'interventionNames': ['Other: Apple pectin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Regular Non-enteric coated aspirin 325mg', 'description': 'Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.', 'interventionNames': ['Drug: Aspirin 325 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Apple pectin + aspirin', 'description': 'Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.', 'interventionNames': ['Other: Apple pectin', 'Drug: Aspirin 325 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator', 'description': 'Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Apple pectin', 'type': 'OTHER', 'description': 'Apple pectin 2000mg', 'armGroupLabels': ['Apple pectin + aspirin', 'Apple-pectin 2000mg']}, {'name': 'Aspirin 325 mg', 'type': 'DRUG', 'description': 'Aspirin 325 mg', 'armGroupLabels': ['Apple pectin + aspirin', 'Regular Non-enteric coated aspirin 325mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Placebo Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Patrick Moriarty, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Patrick Moriarty, MD, FACP, FACC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, Clinical Pharmacology', 'investigatorFullName': 'Patrick Moriarty, MD, FACP, FACC', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}