Oral L-Arginine and ADMA in Pregnancy

This study is not yet open for participant recruitment.

Verified by University of Pittsburgh, August 2008

Sponsors and Collaborators:	University of Pittsburgh Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00743210

Purpose

The purpose of this study is to determine if oral of L-arginine (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.

Condition	Intervention	Phase
Blood Pressure	Drug: L-arginine Drug: Placebo	Phase I

MedlinePlus related topics: Obesity Obesity in Children

Drug Information available for: Arginine Arginine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

To evaluate blood pressure changes in response to oral L-arginine or placebo treatment in uncomplicated obese pregnant women during the second trimester of pregnancy. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	June 2009
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Oral L-arginine, 3 grams once per day for 3 weeks.	Drug: L-arginine Oral L-arginine, 3 grams once per day for 3 weeks.
2: Placebo Comparator Placebo, 3 grams once per day for 3 weeks.	Drug: Placebo Placebo, 3 grams once per day for 3 weeks.

Eligibility

Ages Eligible for Study:	14 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 Criteria:

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-arginine as a supplement (1gram/day or more)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743210

Contacts

Contact: Betsy A Shaw, RN

412-641-4874

shawea2@upmc.edu

Locations

United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:

Carl A Hubel, PhD

Department of Obstetrics & Gynecology and Reproductive Sciences, University of Pittsburgh

More Information

Responsible Party:	Department of Obstetrics & Gynecology and Reproductive Biology, School of Medicine, University of Pittsburgh ( CARL A HUBEL, PHD )
Study ID Numbers:	2P01HD030367-ARG
Study First Received:	August 26, 2008
Last Updated:	August 26, 2008
ClinicalTrials.gov Identifier:	NCT00743210
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

pregnancy
obesity
asymmetric dimethylarginine
L-arginine

Study placed in the following topic categories:

Obesity
N,N-dimethylarginine

ClinicalTrials.gov processed this record on January 16, 2009