Status:
COMPLETED
Oral L-Citrulline and ADMA in Pregnancy
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Blood Pressure
Eligibility:
FEMALE
14-40 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine if oral of L-citrulline (3 grams/day) for 3 weeks provided in mid-pregnancy to obese subjects will decrease the plasma ADMA/L-arginine ratio, lower maternal b...
Detailed Description
The pregnancy-specific syndrome preeclampsia is a leading cause of maternal and fetal morbidity and mortality. The underlying cause of preeclampsia is unknown, however several pre-existing maternal co...
Eligibility Criteria
Inclusion
- Pre-pregnancy body mass index greater than or equal to 30kg/m2
- Primiparity
- Singleton pregnancy
- Gestational age at randomization between 10 and 14 weeks based on clinical information and evaluation of earliest ultrasound
- Maternal age between 14 and 40 years
Exclusion
- chronic hypertension
- pregestational diabetes on medication (insulin, glyburide)
- major fetal anomaly or demise
- planned termination of the pregnancy
- collagen vascular disease (autoimmune disease) on medication
- renal disease
- epilepsy or other seizure disorder
- active or chronic liver disease
- heart disease
- cigarette smoker
- known illicit drug or alcohol abuse during current pregnancy
- already taking L-citrulline as a supplement (1gram/day or more)
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00743210
Start Date
January 1 2010
End Date
June 1 2013
Last Update
July 16 2014
Active Locations (1)
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1
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213