Role of L-citrulline in Prevention of Pregnancy Associated Hypertension
Purpose
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.
Conditions
- Pregnancy Induced Hypertension
- Preeclampsia and Eclampsia
- Gestational Hypertension
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Placebo |
Oral placebo, 3 grams milk powder sachet, taken once daily |
|
|
Experimental Daily L-citrulline |
L-citrulline, 3 grams L-citrulline sachet, taken once daily |
|
Recruiting Locations
Galveston, Texas 77555-0156
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Medical Branch, Galveston
Detailed Description
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.