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Sponsors and Collaborators: |
University of Pittsburgh Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00743210 |
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 |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
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.
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Drug: L-arginine
Oral L-arginine, 3 grams once per day for 3 weeks.
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2: Placebo Comparator
Placebo, 3 grams once per day for 3 weeks.
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Drug: Placebo
Placebo, 3 grams once per day for 3 weeks.
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Ages Eligible for Study: | 14 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Betsy A Shaw, RN | 412-641-4874 | shawea2@upmc.edu |
United States, Pennsylvania | |
Magee-Womens Hospital of UPMC | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Carl A Hubel, PhD | Department of Obstetrics & Gynecology and Reproductive Sciences, University of Pittsburgh |
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 |
pregnancy obesity asymmetric dimethylarginine L-arginine |
Obesity N,N-dimethylarginine |