Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 5:31 AM
Study NCT ID:
NCT04979793
Status:
SUSPENDED
Last Update Posted:
2025-09-19
First Post:
2021-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of L-citrulline in Prevention of Pregnancy Associated Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D004461', 'term': 'Eclampsia'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002956', 'term': 'Citrulline'}], 'ancestors': [{'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 338}}, 'statusModule': {'whyStopped': 'At the request of the PI', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2021-06-16', 'studyFirstSubmitQcDate': '2021-07-16', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of pregnancy induced hypertension', 'timeFrame': 'To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization.', 'description': 'Incidence of pregnancy induced hypertension conditions (gestational hypertension, preeclampsia, or eclampsia) between treatment and placebo groups will be assessed by chart review after end of pregnancy'}], 'secondaryOutcomes': [{'measure': 'Change in bioavailability of L-citrulline and asymmetric dimethyl arginine (ADMA) with oral L-citrulline administration', 'timeFrame': 'Baseline at start of study and again after 8 weeks treatment', 'description': 'Assessment of change in serum L-citrulline and asymmetric dimethyl arginine (ADMA ) levels with L-citrulline administration between treatment and placebo groups. Serum samples will be collected at the beginning of study and after 8 weeks and assayed for ADMA and L-citrulline'}, {'measure': 'Change in maternal nitric oxide levels with L-citrulline supplementation', 'timeFrame': 'Baseline at start of study and again after 8 weeks treatment', 'description': 'Assessment of change in nitric oxide levels between treatment and placebo groups by measurement of baseline and 8 week post treatment urine nitrate and nitrite concentrations'}, {'measure': 'Maternal blood pressure', 'timeFrame': 'Baseline at start of study, and approximately every 1-4 weeks after randomization at prenatal appointments throughout pregnancy. Also at time of delivery approximately 8-9 months after randomization..', 'description': 'Assessment of maternal blood pressure throughout study'}, {'measure': 'Maternal Morbidity', 'timeFrame': 'To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization.', 'description': 'Composite assessment of incidence of maternal outcomes to include development of preeclampsia; Hemolysis, Elevated liver enzymes, Low Platelets (HELLP) syndrome; eclampsia; indicated preterm birth less than 32 weeks due to hypertension related disorders'}, {'measure': 'Birth weight', 'timeFrame': 'To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization.', 'description': 'To assess the actual birthweight of neonate by chart review at time of delivery. This outcome is different than fetal growth restriction noted in outcome 5.'}, {'measure': 'Neonatal Outcomes', 'timeFrame': 'To be assessed by chart review 8-9 months after enrollment at time of delivery', 'description': 'To determine the incidence of neonatal outcomes by chart review after delivery that include respiratory distress syndrome, necrotising enterocolitis, bronchopulmonary dysplasia (BPD), and BPD related pulmonary hypertension, retinopathy of prematurity, age at full feed, and length of hospital stay, fetal growth restriction defined as less than 10% of predicted gestational age, fetal death after 20 weeks gestation, and neonatal death'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregnancy Induced Hypertension'], 'conditions': ['Pregnancy Induced Hypertension', 'Preeclampsia and Eclampsia', 'Gestational Hypertension']}, 'descriptionModule': {'briefSummary': 'The target population for our study is healthy nulliparous pregnant women (first pregnancy) between the 12-16 week of pregnancy.\n\nIf a subject is eligible, written consent will be obtained by person to person contact. Eligible participants will be randomized to receive either daily L-citrulline supplementation or placebo.', 'detailedDescription': 'Healthy nulliparous pregnant women (first pregnancy) between the 12-16 week of pregnancy will be eligible for this study. The purpose of this study will be to determine if daily supplementation of oral L-citrulline can reduce the incidence of pregnancy induced hypertension. This will be a double blind study, subjects will be randomized to receive either L-citrulline (3 gram sachet) or a placebo for a total of 8 weeks. Participants will be asked to provide urine and blood samples at time of enrollment, be asked to respond to a phone survey to assess for side effects, and again be asked to provide urine and blood samples at the end of 8 weeks. Participants will continue with routine prenatal care throughout the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nulliparous (no previous pregnancy greater than 20 weeks)\n* Gestational age of pregnancy between 12 and 16 weeks\n\nExclusion Criteria:\n\n* Known fetal anomaly or chromosomal abnormality\n* Early fetal growth restriction\n* Fetal demise or planned termination\n* Participation in another study that may influence this study\n* Known maternal kidney disease\n* Known maternal electrolyte imbalance\n* Known allergies to study interventions\n* Preexisting hypertension (chronic hypertension)\n* Known gastric ulcer\n* Incarcerated status\n* Planned delivery at non-UTMB hospital\n* Known lactose intolerance'}, 'identificationModule': {'nctId': 'NCT04979793', 'briefTitle': 'Role of L-citrulline in Prevention of Pregnancy Associated Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'Role of L-citrulline in Prevention of Pregnancy Associated Hypertension in Nulliparous Women', 'orgStudyIdInfo': {'id': '20-0167'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo', 'description': 'Oral placebo, 3 grams milk powder sachet, taken once daily', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Daily L-citrulline', 'description': 'L-citrulline, 3 grams L-citrulline sachet, taken once daily', 'interventionNames': ['Drug: L-citrulline']}], 'interventions': [{'name': 'L-citrulline', 'type': 'DRUG', 'description': '3 gram sachet, L-citrulline', 'armGroupLabels': ['Daily L-citrulline']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Milk powder placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555-0156', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}