Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-30 @ 1:37 AM
Study NCT ID:
NCT04271735
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2020-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C018613', 'term': 'nicotinamide-beta-riboside'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sackm@nhlbi.nih.gov', 'phone': '301.402.9259', 'title': 'Michael Sack, M.D. Principal Investigator, NIH, NHLBI', 'organization': 'National Heart Lung and Blood Institute (NHLBI)'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to day 35', 'description': 'Grade 2 - 5 adverse events and serious adverse events whether volunteered by the patient, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.', 'eventGroups': [{'id': 'EG000', 'title': 'Participants With Mild to Moderate Psoriasis Receiving Nicotinamide Riboside', 'description': 'Participants with mild to moderate Psoriasis receiving Nicotinamide Riboside Chloride 500mg (2 capsules) twice daily by mouth for 28 days.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 1, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Participants With Mild to Moderate Psoriasis Receiving Placebo', 'description': 'Participants with mild to moderate Psoriasis receiving placebo (2 capsules) twice daily by mouth for 28 days.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 1, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in the TH17 Cell Cytokine IL-17 Secretion in Response to T-cell Differentiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Mild to Moderate Psoriasis Receiving Nicotinamide Riboside', 'description': 'Participants with mild to moderate Psoriasis receiving Nicotinamide Riboside Chloride 500mg (2 capsules) twice daily by mouth for 28 days.'}, {'id': 'OG001', 'title': 'Participants With Mild to Moderate Psoriasis Receiving Placebo', 'description': 'Participants with mild to moderate Psoriasis receiving placebo (2 capsules) twice daily by mouth for 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-176.9', 'spread': '174.7', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '120.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 28', 'description': 'Mean change in the TH17 cell cytokine IL-17 secretion in response to T-cell differentiation comparing the baseline versus NR or placebo.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from placebo group not included in analysis due to insufficient T-cells. One participant from Nicotinamide Riboside group not included in analysis due to abnormal lipids.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants With Mild to Moderate Psoriasis Receiving Nicotinamide Riboside', 'description': 'Participants with mild to moderate Psoriasis receiving Nicotinamide Riboside Chloride 500mg (2 capsules) twice daily by mouth for 28 days.'}, {'id': 'FG001', 'title': 'Participants With Mild to Moderate Psoriasis Receiving Placebo', 'description': 'Participants with mild to moderate Psoriasis receiving placebo (2 capsules) twice daily by mouth for 28 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants With Mild to Moderate Psoriasis Receiving Nicotinamide Riboside', 'description': 'Participants with mild to moderate Psoriasis receiving Nicotinamide Riboside Chloride 500mg (2 capsules) twice daily by mouth for 28 days.'}, {'id': 'BG001', 'title': 'Participants With Mild to Moderate Psoriasis Receiving Placebo', 'description': 'Participants with mild to moderate Psoriasis receiving placebo (2 capsules) twice daily by mouth for 28 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-21', 'size': 1121953, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-09-29T12:49', 'hasProtocol': True}, {'date': '2021-04-16', 'size': 372608, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-07-06T09:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2020-02-14', 'resultsFirstSubmitDate': '2023-12-04', 'studyFirstSubmitQcDate': '2020-02-14', 'lastUpdatePostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-04', 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in the TH17 Cell Cytokine IL-17 Secretion in Response to T-cell Differentiation', 'timeFrame': 'Baseline and Day 28', 'description': 'Mean change in the TH17 cell cytokine IL-17 secretion in response to T-cell differentiation comparing the baseline versus NR or placebo.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Inflammatory Skin Disease', 'Systemic Inflammation-Induced Atherosclerosis', 'TH17 Cell Cytokine IL-17 Secretion in Response to T-cell Differentiation', 'Effect of NR on Neutrophils', 'Effect of NR on HDL'], 'conditions': ['Psoriasis', 'Atherosclerotic Cardiovascular Disease', 'Obesity', 'Dyslipidemia', 'Cardiometabolic Diseases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2020-H-0044.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nPsoriasis causes chronic inflammation in the body. Researchers want to see if a kind of vitamin B3 dietary supplement can help. This might lead to more treatment options.\n\nObjective:\n\nTo test if the dietary supplement nicotinamide riboside can improve immune system function in the blood and skin of people with mild to moderate psoriasis.\n\nEligibility:\n\nPeople ages 18-80 with mild to moderate active psoriasis not currently treated with biological therapy\n\nDesign:\n\nParticipations will be screened with:\n\n* Medical and medication history\n* Physical exam\n* Measure of body mass index\n* Skin exam\n* Blood and urine tests\n\nParticipants will have visit 1. They will have repeats of the screening tests. They may also have 2 skin biopsies, which are optional. These will be from both lesions and unaffected areas. The areas will be injected with a numbing medicine. A round cutting device will remove small pieces of skin from each area.\n\nParticipants will take the study supplement or a placebo starting at the first visit. Neither participants nor the study team will know which they receive. Participants will take capsules twice daily for a total of 4 weeks.\n\nParticipants will then have visit 2. This will include the tests performed at visit 1.\n\nParticipants may by contacted by phone or email between visits to see how they are doing.\n\nIf participants develop any side effects in the 7 days after they stop taking the capsules, they may have another visit.', 'detailedDescription': 'Study Description:\n\nPsoriasis is a Th17 linked inflammatory disease and we find that the vitamin B3 analogue nicotinamide riboside (NR) blunts Th1 and Th17 activation in ex-vivo na(SqrRoot) ve and differentiated T cells from control and psoriasis subjects. These findings supported the proposal of the following hypothesis. Supplementation with NR will blunt systemic immune activation in mild/moderate psoriasis.\n\nObjectives:\n\n1\\) Evaluate the effect of NR on Th17 biology\n\nEndpoints:\n\nThe primary outcome will be the change in the TH17 cell cytokine IL-17 secretion in response to T-cell differentiation comparing the baseline versus NR or placebo. The comparisons will be performed using paired two-tailed Student t-tests. Significance will be tested at the 0.05 alpha level in this pilot study.\n\nExploratory outcomes are:\n\n1. Evaluate the effect of NR on the T cell transcriptome\n2. Explore the effect of NR on low-density granulocytes and neutrophils\n\nStudy Population:\n\nUp to 40 male and female subjects of all races between the ages of 18-80 years with mild-moderate psoriasis who live locally will be screened.\n\nEnrollment and study visits will take place at the NIH Clinical Center or via telehealth visits.\n\nEnrolling Participants:\n\nPsoriatic Subjects\n\nDescription of Study Intervention:\n\nNicotinamide Riboside Chloride 500mg or placebo twice daily by mouth for 28 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nIndividuals must meet all inclusion criteria listed below in order to be eligible to participate in the study.\n\n* Males and females between the ages of 18 and 80 with mild to moderate active psoriasis.\n* Female subjects of child-bearing ability willing to commit to reliable contraception while participating in the study.\n* Ability to provide informed consent\n* Willingness and ability to participate in required study procedures\n\nEXCLUSION CRITERIA:\n\n* Severe psoriasis by PASI (Psoriasis Area and Severity Index) score \\> 12\n* Currently being treated with biologic immune modifying agents.\n* Currently on treatment for allergies or other inflammatory diseases.\n* Currently taking a multivitamin, Vitamin B or tryptophan supplementation and unwilling to stop within 2 weeks of baseline visit.\n* Unwillingness/inability to provide informed consent\n* ALT \\> x3 upper limit of normal, hepatic insufficiency or active liver disease\n* Recent history of acute gout\n* Chronic renal insufficiency with creatinine \\> 2.5mg/dl\n* Pregnant (or attempting to become pregnant) women\n* Current participation in another drug study\n* History of intolerance to NR precursor compounds, including niacin or nicotinamide\n* Study adherence concerns\n* Individuals with diabetes type 1 and 2 who use insulin\n* Women of child-bearing potential unwilling to use contraception or unwilling to practice abstinence\n* Breastfeeding women unwilling to stop breastfeeding\n* Immunization administered within 30 days of participation and no plans for immunization while participating in the study'}, 'identificationModule': {'nctId': 'NCT04271735', 'briefTitle': 'Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis', 'orgStudyIdInfo': {'id': '200044'}, 'secondaryIdInfos': [{'id': '20-H-0044'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Participants with mild to moderate Psoriasis receiving Placebo', 'description': 'Participants with mild to moderate Psoriasis receiving placebo (2 capsules) twice daily by mouth for 28 days.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Participants with mild to moderate Psoriasis receiving Nicotinamide Riboside', 'description': 'Participants with mild to moderate Psoriasis receiving Nicotinamide Riboside Chloride 500mg (2 capsules) twice daily by mouth for 28 days.', 'interventionNames': ['Dietary Supplement: Niagen']}], 'interventions': [{'name': 'Niagen', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Nicotinamide Riboside Chloride', 'Nicotinamide Riboside'], 'description': 'Participants will take two capsules of nicotinamide riboside (NR) by mouth (250mg NR or placebo) twice daily for a total of 4 weeks.', 'armGroupLabels': ['Participants with mild to moderate Psoriasis receiving Nicotinamide Riboside']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo capsule to match the active supplement. Participants will take two capsules, twice daily for a total of 4 weeks.', 'armGroupLabels': ['Participants with mild to moderate Psoriasis receiving Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Michael N Sack, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Heart, Lung, and Blood Institute (NHLBI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}