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

ArmDescriptionAssigned Intervention
Active Comparator
Placebo 		Oral placebo, 3 grams milk powder sachet, taken once daily
  • Drug: Placebo
    Milk powder placebo
Experimental
Daily L-citrulline 		L-citrulline, 3 grams L-citrulline sachet, taken once daily
  • Drug: L-citrulline
    3 gram sachet, L-citrulline

More Details

Status
Suspended
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

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.