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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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.