Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT03579693
Status:
COMPLETED
Last Update Posted:
2023-01-10
First Post:
2018-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Trial of Nicotinamide Riboside and Co-enzyme Q10 in Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024989', 'term': 'coenzyme Q10'}, {'id': 'C018613', 'term': 'nicotinamide-beta-riboside'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'brk@uw.edu', 'phone': '206-685-7343', 'title': 'Bryan Kestenbaum, MD', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'For each treatment arm, adverse events are reported from the start of the treatment until the next visit (approximately 6 weeks total for each treatment).', 'description': 'Definitions used were consistent with clinicaltrials.gov. At each visit potential adverse events were assessed by participant interview.', 'eventGroups': [{'id': 'EG000', 'title': 'CoQ10', 'description': 'Coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nicotinamide Riboside', 'description': 'Nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 1, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo, inactive sugar pill for 6 weeks', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 2, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upper respiratory illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximal Aerobic Capacity- CoQ10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CoQ10', 'description': 'Coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks\n\nCoQ10: CoQ10 tablet'}, {'id': 'OG001', 'title': 'Nicotinamide Riboside', 'description': 'Nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo, inactive sugar pill for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '21.4', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '20.7', 'spread': '4.7', 'groupId': 'OG001'}, {'value': '20.7', 'spread': '4.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.44', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '1.31', 'estimateComment': 'Interpretation of mean difference is for a typical participant, i.e. random effect of 0.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.93', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '0.82', 'estimateComment': 'Interpretation of mean difference is for a typical participant, i.e. random effect of 0.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'The maximal aerobic capacity (oxygen uptake mL/min/kg body weight) during cycle ergometry at the end of each treatment period.', 'unitOfMeasure': 'mL/min/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants that completed cycle ergometry following each treatment period.'}, {'type': 'PRIMARY', 'title': 'Work Efficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CoQ10', 'description': 'Coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks'}, {'id': 'OG001', 'title': 'Nicotinamide Riboside', 'description': 'Nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo, inactive sugar pill for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '32.5', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '33.1', 'spread': '5.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.050', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.76', 'ciLowerLimit': '-3.47', 'ciUpperLimit': '0.00', 'estimateComment': 'Interpretation of mean difference is for a typical participant, i.e. random effect of 0.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.47', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.62', 'ciLowerLimit': '-2.28', 'ciUpperLimit': '1.05', 'estimateComment': 'Interpretation of mean difference is for a typical participant, i.e. random effect of 0.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'The work efficiency (oxygen uptake mL/min/kg body weight at a specified constant of 60 watts work rate for 3 minutes) during cycle ergometry at the end of each treatment period. This is reported as the work performed at 60 watts divided by the energy expended at 0 watts times 100, and reported on the percent scale..', 'unitOfMeasure': 'Percent difference', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants randomized and treated who complete cycle ergometry at the end of the corresponding treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo, Then Nicotinamide Riboside, Then CoQ10', 'description': 'Placebo, inactive sugar pill for 6 weeks; then washout for 1 week; then nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks; then washout for 1 week; then coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks.'}, {'id': 'FG001', 'title': 'Placebo, Then CoQ10, Then Nicotinamide Riboside', 'description': 'Placebo, inactive sugar pill for 6 weeks; then washout for 1 week; then coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks; then washout for 1 week; then nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks.'}, {'id': 'FG002', 'title': 'Nicotinamide Riboside, Then Placebo, Then CoQ10', 'description': 'Nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks; then washout for 1 week; placebo, inactive sugar pill for 6 weeks; then washout for 1 week; then coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks.'}, {'id': 'FG003', 'title': 'Nicotinamide Riboside, Then CoQ10, Then Placebo', 'description': 'Nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks; then washout for 1 week; then coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks; then washout for 1 week; placebo, inactive sugar pill for 6 weeks.'}, {'id': 'FG004', 'title': 'CoQ10, Then Placebo, Then Nicotinamide Riboside', 'description': 'Coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks; then washout for 1 week; then placebo, inactive sugar pill for 6 weeks; then washout for 1 week; then nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks.'}, {'id': 'FG005', 'title': 'CoQ10, Then Nicotinamide Riboside, Then Placebo', 'description': 'Coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks; then washout for 1 week; then nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks; then washout for 1 week; then placebo, inactive sugar pill for 6 weeks.'}], 'periods': [{'title': 'First Intervention (6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}, {'title': 'Washout (1 Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Second Washout (1 Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention (6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo, Then Nicotinamide Riboside, Then CoQ10', 'description': 'Placebo, inactive sugar pill for 6 weeks; then washout for 1 week; then nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks; then washout for 1 week; then coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks.'}, {'id': 'BG001', 'title': 'Placebo, Then CoQ10, Then Nicotinamide Riboside', 'description': 'Placebo, inactive sugar pill for 6 weeks; then washout for 1 week; then coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks; then washout for 1 week; then nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks.'}, {'id': 'BG002', 'title': 'Nicotinamide Riboside, Then Placebo, Then CoQ10', 'description': 'Nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks; then washout for 1 week; placebo, inactive sugar pill for 6 weeks; then washout for 1 week; then coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks.'}, {'id': 'BG003', 'title': 'Nicotinamide Riboside, Then CoQ10, Then Placebo', 'description': 'Nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks; then washout for 1 week; then coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks; then washout for 1 week; placebo, inactive sugar pill for 6 weeks.'}, {'id': 'BG004', 'title': 'CoQ10, Then Placebo, Then Nicotinamide Riboside', 'description': 'Coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks; then washout for 1 week; then placebo, inactive sugar pill for 6 weeks; then washout for 1 week; then nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks.'}, {'id': 'BG005', 'title': 'CoQ10, Then Nicotinamide Riboside, Then Placebo', 'description': 'Coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks; then washout for 1 week; then nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks; then washout for 1 week; then placebo, inactive sugar pill for 6 weeks.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'spread': '3.0', 'groupId': 'BG000'}, {'value': '63.4', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '63.6', 'spread': '4.8', 'groupId': 'BG002'}, {'value': '56.2', 'spread': '16.3', 'groupId': 'BG003'}, {'value': '64.0', 'spread': '7.5', 'groupId': 'BG004'}, {'value': '58.2', 'spread': '22.6', 'groupId': 'BG005'}, {'value': '61.5', 'spread': '11.7', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '25', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], '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'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'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': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'eGFR per 2021 CKD-EPI', 'classes': [{'categories': [{'measurements': [{'value': '33.6', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '39.3', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '32.6', 'spread': '7.8', 'groupId': 'BG002'}, {'value': '34.6', 'spread': '10.5', 'groupId': 'BG003'}, {'value': '45.2', 'spread': '8.0', 'groupId': 'BG004'}, {'value': '36.0', 'spread': '4.5', 'groupId': 'BG005'}, {'value': '37.0', 'spread': '9.0', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '27.9', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '27.9', 'spread': '4.8', 'groupId': 'BG001'}, {'value': '29.6', 'spread': '4.0', 'groupId': 'BG002'}, {'value': '25.3', 'spread': '4.6', 'groupId': 'BG003'}, {'value': '25.8', 'spread': '2.7', 'groupId': 'BG004'}, {'value': '29.9', 'spread': '8.4', 'groupId': 'BG005'}, {'value': '27.7', 'spread': '5.2', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-08', 'size': 727246, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-11-15T16:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, placebo-controlled, cross-over trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-13', 'studyFirstSubmitDate': '2018-06-25', 'resultsFirstSubmitDate': '2022-10-12', 'studyFirstSubmitQcDate': '2018-07-05', 'lastUpdatePostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-13', 'studyFirstPostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal Aerobic Capacity- CoQ10', 'timeFrame': '6 weeks', 'description': 'The maximal aerobic capacity (oxygen uptake mL/min/kg body weight) during cycle ergometry at the end of each treatment period.'}, {'measure': 'Work Efficiency', 'timeFrame': '6 weeks', 'description': 'The work efficiency (oxygen uptake mL/min/kg body weight at a specified constant of 60 watts work rate for 3 minutes) during cycle ergometry at the end of each treatment period. This is reported as the work performed at 60 watts divided by the energy expended at 0 watts times 100, and reported on the percent scale..'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mitochondria', 'Antioxidants', 'CoQ10', 'Nicotinamide riboside', 'Ergometry', 'Fatigue', 'Aerobic capacity'], 'conditions': ['Chronic Kidney Disease', 'Sarcopenia', 'Frailty']}, 'referencesModule': {'references': [{'pmid': '39847432', 'type': 'DERIVED', 'citation': 'Ahmadi A, Valencia AP, Begue G, Norman JE, Fan S, Durbin-Johnson BP, Jenner BN, Campbell MD, Reyes G, Kapahi P, Himmelfarb J, de Boer IH, Marcinek DJ, Kestenbaum BR, Gamboa JL, Roshanravan B. A Pilot Trial of Nicotinamide Riboside and Coenzyme Q10 on Inflammation and Oxidative Stress in CKD. Clin J Am Soc Nephrol. 2025 Mar 1;20(3):346-357. doi: 10.2215/CJN.0000000624. Epub 2025 Jan 23.'}, {'pmid': '37159264', 'type': 'DERIVED', 'citation': 'Ahmadi A, Begue G, Valencia AP, Norman JE, Lidgard B, Bennett BJ, Van Doren MP, Marcinek DJ, Fan S, Prince DK, Gamboa J, Himmelfarb J, de Boer IH, Kestenbaum BR, Roshanravan B. Randomized crossover clinical trial of coenzyme Q10 and nicotinamide riboside in chronic kidney disease. JCI Insight. 2023 Jun 8;8(11):e167274. doi: 10.1172/jci.insight.167274.'}], 'seeAlsoLinks': [{'url': 'https://kri.washington.edu', 'label': 'Website for the Kidney Research Institute at the University of Washington'}]}, 'descriptionModule': {'briefSummary': 'Chronic kidney disease is associated with the loss of skeletal muscle mass and function. This process detrimentally impacts mobility, functional independence, and quality of life. Mounting evidence suggests that chronic kidney disease impairs skeletal muscle functioning by injuring mitochondria, the central energy producing units of cells.\n\nPotential treatment options to restore mitochondrial function include aerobic and weight bearing exercise and medications that directly improve mitochondrial energetics. Unfortunately, exercise programs may be difficult to implement in people who have chronic diseases, such as kidney disease.. Coenzyme Q10 (coQ10) and nicotinamide riboside (NR) are naturally occurring supplements that can directly improve mitochondrial efficiency. Both compounds help mitochondria produce more energy while generating less waste.\n\nThe primary purpose of this study is to test whether coQ10 and NR can improve muscle function among people with chronic kidney disease. What we learn in this study may help us better understand the mechanisms of skeletal muscle impairment among people with kidney disease and ultimately improve their ability to be active and independent.', 'detailedDescription': "Sarcopenia (decreased muscle mass or function) is common in patients with chronic kidney disease (CKD) patients with direct impacts on their metabolic and clinical outcomes. Existing evidence and the investigator's preliminary data suggest that mitochondrial dysfunction is a key underlying mechanism of sarcopenia in CKD. However, the ability of treatments to modify mitochondrial functioning in CKD patients is unknown. Coenzyme Q10 (coQ10) and nicotinamide riboside (NR) are naturally occurring supplements that reduce oxidative stress and restore substrate delivery to mitochondria, respectively.\n\nBoth processes have the potential to increase mitochondrial energy production with direct consequences for many metabolic and physical processes, including:\n\n* aerobic capacity\n* work efficiency\n* mitochondrial energetics\n* fatigue\n* physical function\n* inflammation\n* oxidative stress\n* heart failure symptoms\n* metabolomics\n\nThese outcomes will assessed in all study participants who enroll in the trial. Addressing these knowledge gaps is necessary to shed new light on the pathophysiology of sarcopenia in CKD and suggest future interventions that reduce morbidity and mortality.\n\nThis is a randomized, placebo-controlled, double-blind crossover trial of coQ10 and NR treatments. Participants will receive coQ10 (1000 mg daily), NR (1200 mg daily), or placebo each for six-weeks in random order with a 7-day washout between treatment periods. The primary outcomes are aerobic capacity and muscle work efficiency, measured during cycle ergometry."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic kidney disease, defined in this study as an estimated glomerular filtration rate (eGFR) of \\<50ml/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration equation\n\nExclusion Criteria:\n\n* 6-minute walking distance \\>500meters\n* Pregnancy\n* Receiving renal replacement therapy (dialysis or kidney transplantation)\n* Expectation to start dialysis within 6 months\n* Insulin dependent diabetes mellitus\n* Severe anemia: hemoglobin \\<8 g/dL\n* Hyperkalemia: K \\>5.7 mEq/L\n* Weight \\>300 lbs\n* HIV\n* End stage liver disease with cirrhosis\n* Oxygen-dependent Chronic Obstructive Pulmonary Disease (COPD)\n* Unable to walk unassisted from room to room in own house\n* Institutionalization, or inability to consent\n* Use of immunosuppressive medications (i.e. steroids, calcineurin inhibitors)\n* Malignancy requiring active treatment or currently under surveillance (at the discretion of the investigator)\n* Cardiac pacemaker\n* Current participation in another interventional trial\n* Non-English speaking\n* Hospitalization for heart attack, stroke, or unstable cardiac chest pain within the previous 3 months (e.g. myocardial infarction, unstable angina, cerebrovascular accident)\n* Any medical condition that the investigator feels would prevent the participant from safely completing the exercise-based outcome measurements.\n* Baseline systolic blood pressure \\>170 or diastolic blood pressure \\>100\n* Persistent or permanent uncontrolled arrhythmia (at the discretion of the investigator)'}, 'identificationModule': {'nctId': 'NCT03579693', 'acronym': 'CoNR', 'briefTitle': 'Trial of Nicotinamide Riboside and Co-enzyme Q10 in Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Cross-over Randomized Controlled Trial of Coenzyme Q10 or Nicotinamide Riboside in Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'STUDY00004998'}, 'secondaryIdInfos': [{'id': 'R01DK101509', 'link': 'https://reporter.nih.gov/quickSearch/R01DK101509', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CoQ10', 'description': 'Coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks', 'interventionNames': ['Dietary Supplement: CoQ10']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nicotinamide riboside', 'description': 'Nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks', 'interventionNames': ['Dietary Supplement: Nicotinamide riboside']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo, inactive sugar pill for 6 weeks', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'CoQ10', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['coenzyme Q10'], 'description': 'CoQ10 tablet', 'armGroupLabels': ['CoQ10']}, {'name': 'Nicotinamide riboside', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['NR'], 'description': 'NR tablet', 'armGroupLabels': ['Nicotinamide riboside']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Sugar pill designed to mimic coQ10 and NR', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Bryan Kestenbaum, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}, {'name': 'Baback Roshanravan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, School of Medicine: Department of Medicine: Nephrology', 'investigatorFullName': 'Bryan Kestenbaum', 'investigatorAffiliation': 'University of Washington'}}}}