Oral L-Citrulline and ADMA in Pregnancy
Phase 1 Study of Oral L-citrulline on ADMA/L-arginine and Endothelial-dependent Vascular Function in Pregnancy.
2 other identifiers
interventional
41
1 country
1
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 blood pressure, improve endothelial-dependent vascular function and peripheral vascular stiffness, and improve uterine artery Doppler resistance and flow.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2010
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2008
CompletedFirst Posted
Study publicly available on registry
August 28, 2008
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJuly 16, 2014
July 1, 2014
3.4 years
August 26, 2008
July 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate blood pressure changes in response to oral L-citrulline or placebo treatment in uncomplicated obese pregnant women during the second trimester of pregnancy.
3 weeks
Secondary Outcomes (1)
To evaluate the changes in plasma ADMA/L-arginine ratio, endothelial-dependent vascular function and peripheral vascular stiffness, and uterine artery Doppler resistance and flow.
3 weeks
Study Arms (2)
1
EXPERIMENTALOral L-citrulline, 3 grams once per day for 3 weeks.
2
PLACEBO COMPARATORPlacebo, 3 grams once per day for 3 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carl A Hubel, PhD
Department of Obstetrics & Gynecology and Reproductive Sciences, University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 26, 2008
First Posted
August 28, 2008
Study Start
January 1, 2010
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
July 16, 2014
Record last verified: 2014-07