Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-04-10 @ 12:39 AM
Study NCT ID:
NCT02213094
Status:
COMPLETED
Last Update Posted:
2018-11-02
First Post:
2014-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase I Study of Nicotinamide for Early Onset Preeclampsia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009536', 'term': 'Niacinamide'}], 'ancestors': [{'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kboggess@med.unc.edu', 'phone': '919-966-1601', 'title': 'Kim Boggess MD Principal Investigator', 'organization': 'UNC at Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During study agent administration (up to 14 days)', 'eventGroups': [{'id': 'EG000', 'title': 'Nicotinamide 500 mg', 'description': 'Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Nicotinamide 1000 mg', 'description': 'Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Renal failure', 'notes': 'Subject #5 required dialysis following delivery of her infant. Her serum creatinine was normal at enrollment and throughout study agent administration. She developed renal failure following delivery, which required 2 dialysis treatments.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated LFTs', 'notes': 'Subject #4 had elevated LFTs \\< 24 hours after first dose of study agent. This was believed to be due to the disease process and thus the primary clinical provider opted to proceed with infant delivery, therefore study agent was discontinued.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nicotinamide 500 mg', 'description': 'Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first.'}, {'id': 'OG001', 'title': 'Nicotinamide 1000 mg', 'description': 'Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 48 hours of dosing', 'description': 'Specific adverse events were Maternal liver toxicity, defined as \\> 3x ULN of ALT(Alanine amniotransferase) or AST (Aspartate amniotransferase), maternal report of side effects, and fetal adverse effects.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nicotinamide 500 mg', 'description': 'Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first.'}, {'id': 'FG001', 'title': 'Nicotinamide 1000 mg', 'description': 'Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'One subject stopped study agent early because of elevation in LFTs \\> 3x ULN', 'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nicotinamide 500 mg', 'description': 'Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first.'}, {'id': 'BG001', 'title': 'Nicotinamide 1000 mg', 'description': 'Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first.'}, {'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': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Phase 1 dose escalation study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2015-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-15', 'studyFirstSubmitDate': '2014-08-07', 'resultsFirstSubmitDate': '2018-01-22', 'studyFirstSubmitQcDate': '2014-08-08', 'lastUpdatePostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-15', 'studyFirstPostDateStruct': {'date': '2014-08-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Within 48 hours of dosing', 'description': 'Specific adverse events were Maternal liver toxicity, defined as \\> 3x ULN of ALT(Alanine amniotransferase) or AST (Aspartate amniotransferase), maternal report of side effects, and fetal adverse effects.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['preeclampsia', 'pregnancy-induced hypertension', 'nicotinamide'], 'conditions': ['Pregnancy Induced Hypertension', 'Superimposed Preeclampsia', 'Hypertension']}, 'descriptionModule': {'briefSummary': "This is a Phase I study of vitamin B3-amide (nicotinamide) dietary supplementation in pregnant women with early onset preeclampsia. The investigators will enroll 10 pregnant women at 24-32 weeks' gestation with the diagnosis of preeclampsia. If the woman is anticipated to remain undelivered for 48 hours after diagnosis she will receive vitamin B3-amide, 500 mg/day given in the morning (n=5) or 1000 mg given in the morning (n=5), continuing until delivery or for 14 days, whichever occurs first. Maternal blood will be collected at baseline and twice a day on days 1, 3, and 7 of nicotinamide administration to measure nicotinamide metabolites, The objectives of this Phase I study are to to test safety of nicotinamide."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Maternal age 18-45 years\n2. Informed written consent\n3. Preeclampsia or new onset hypertension between 24-32 completed weeks' gestation\n\n 1. Hypertensive complications of pregnancy defined as new onset systolic BP \\> 140 mm Hg and/or diastolic BP \\> 90 mm Hg on two occasions 6 hours apart; OR \\> 300 mg proteinuria on 24 hour urine collection OR urine P/C ratio \\>0.3;\n 2. Dating criteria based on menstrual dating confirmed by first or second trimester ultrasound OR second trimester ultrasound if menstrual dating unavailable;\n 3. Deemed clinically stable by primary clinician and candidate for expectant management (delayed delivery);\n4. Maternal liver function tests \\< 3x ULN\n5. Maternal platelet count \\> 100,000 mm3\n6. Fetal well-being established by estimated fetal weight \\> 5th %tile; normal amniotic fluid volume (MVP \\> 2 cm); normal Umbilical Artery Dopplers; AND reactive NST(non-stress test) or BPP (biophysical profile) \\> 6\n7. Plan for expectant management until delivery\n8. Delivery not anticipated within first 48 hours\n\nExclusion Criteria:\n\n1. Preeclampsia \\< 24 or \\> 33 weeks' gestation;\n2. Suspected fetal structural or chromosomal abnormality;\n3. Pre-existing renal disease (creatinine \\> 1.5 mg/dL)\n4. Pre-existing vascular disease (systemic lupus; cardiac disease;)\n5. Plan for delivery within 48 hours\n6. Any pre-existing medical condition that would increase risk for liver toxicity (e.g. hepatitis B or C; HIV)\n7. Evidence of cerebral dysfunction (seizures; cerebral edema on CT/MRI; headache unresolved with oral analgesics)\n8. Pulmonary edema\n9. HELLP (hemolysis, elevated liver enzymes, low platelets syndrome)\n10. Evidence of liver dysfunction (LFTs \\> 3x ULN)\n11. Thrombocytopenia (platelets \\< 100,000 mm3)\n12. Evidence of fetal compromise: EFW(estimated fetal weight) \\< 5th percentile; BPP \\< 6; absent or reverse diastolic UA blood flow; oligohydramnios (MVP \\< 2 cm)\n13. Placental abruption defined as unexplained vaginal bleeding\n14. Preterm labor defined as regular contractions and cervical change\n15. Any condition deemed by the investigator to be a risk to mother or fetus in completion of the study\n16. Any condition deemed by the investigator to require delivery within 48 hours"}, 'identificationModule': {'nctId': 'NCT02213094', 'briefTitle': 'Phase I Study of Nicotinamide for Early Onset Preeclampsia', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Phase I Study of Nicotinamide for Early Onset Preeclampsia', 'orgStudyIdInfo': {'id': '13-2203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nicotinamide 500 mg', 'description': 'Nicotinamide 500 mg by mouth each morning until delivery or 14 days, whichever occurs first.', 'interventionNames': ['Drug: Nicotinamide 500 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Nicotinamide 1000 mg', 'description': 'Nicotinamide 1000 mg by mouth each morning until delivery or 14 days, whichever occurs first.', 'interventionNames': ['Drug: Nicotinamide 1000 mg']}], 'interventions': [{'name': 'Nicotinamide 500 mg', 'type': 'DRUG', 'otherNames': ['Vitamin B3 amide'], 'description': 'Nicotinamide 500 mg taken by mouth each morning', 'armGroupLabels': ['Nicotinamide 500 mg']}, {'name': 'Nicotinamide 1000 mg', 'type': 'DRUG', 'otherNames': ['Vitamin B3 amide'], 'description': 'Nicotinamide 1000 mg taken by mouth each morning', 'armGroupLabels': ['Nicotinamide 1000 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599-7516', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': "University of North Carolina Women's Hospital", 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Kim A Boggess, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'North Carolina Translational and Clinical Sciences Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}