Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Role of L-citrulline in Prevention of Pregnancy Associated Hypertension in Nulliparous Women

ID
Name
20-0167
Description
The target population for our study is healthy nulliparous pregnant women (first pregnancy) between the 12-16 week of pregnancy. If 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.
Trial arms
Trial start
2021-07-28
Estimated PCD
2024-07-30
Trial end
2024-07-30
Phase
Early phase I
Treatment
L-citrulline
3 gram sachet, L-citrulline
Arms:
Daily L-citrulline
Placebo
Milk powder placebo
Arms:
Placebo
Size
338
Primary endpoint
Incidence of pregnancy induced hypertension
To be assessed by chart review at time of delivery which generally will occur 8-9 months after randomization.
Eligibility criteria
Inclusion Criteria: * Nulliparous (no previous pregnancy greater than 20 weeks) * Gestational age of pregnancy between 12 and 16 weeks Exclusion Criteria: * Known fetal anomaly or chromosomal abnormality * Early fetal growth restriction * Fetal demise or planned termination * Participation in another study that may influence this study * Known maternal kidney disease * Known maternal electrolyte imbalance * Known allergies to study interventions * Preexisting hypertension (chronic hypertension) * Known gastric ulcer * Incarcerated status * Planned delivery at non-UTMB hospital * Known lactose intolerance
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 338, 'type': 'ESTIMATED'}}
Updated at
2023-08-16

1 organization

1 product

1 drug

3 indications

Organization
University of Texas Medical Branch
Product
L-citrulline
Indication
Hypertensive Disorders of Pregnancy
Indication
Preeclampsia
Indication
Gestational Hypertension
Drug
Varlilumab