Study Stopped
Recruitment and follow-up has been completed.
L-Arginine and Antioxidant Vitamins During Pregnancy to Reduce Preeclampsia
L-Arg
Supplementation With L-Arginine and Antioxidant Vitamins During Pregnancy in a Medical Food to Reduce the Risk of Preeclampsia in a High Risk Population
1 other identifier
interventional
585
2 countries
2
Brief Summary
This study is intended to assess the efficacy of L-arginine supplementation with antioxidant vitamins delivered in a medical food in reducing the incidence of preeclampsia in a high-risk population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2001
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 4, 2007
CompletedFirst Posted
Study publicly available on registry
May 7, 2007
CompletedMay 8, 2007
April 1, 2007
May 4, 2007
May 7, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Development of preeclampsia
During pregnancy
Secondary Outcomes (4)
Development of eclampsia
During pregnancy
Occurrence of HELP syndrome
During pregnancy
Occurrence of preterm labor, preterm premature rupture of the membranes
During pregnancy
Gestational age at delivery
End of pregnancy
Interventions
Eligibility Criteria
You may qualify if:
- Previous pregnancy complicated with pre-eclampsia/eclampsia
- Singleton pregnancy
- Gestational age \>20 weeks \<34 weeks
- Protein excretion \< 300 mg/day
You may not qualify if:
- Multiple gestation
- Major fetal anomaly
- Pre-existing hypertension
- Pre-existing renal disease
- Diabetes
- Collagen vascular disease
- Cancer or strong family history of cancer in first degree relatives
- Preexisting maternal disease requiring medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Univesity of Pennsylvania
Philadelphia, Pennsylvania, 19104-6142, United States
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Mexico City, D.F., 11000, Mexico
Related Publications (1)
Vadillo-Ortega F, Perichart-Perera O, Espino S, Avila-Vergara MA, Ibarra I, Ahued R, Godines M, Parry S, Macones G, Strauss JF. Effect of supplementation during pregnancy with L-arginine and antioxidant vitamins in medical food on pre-eclampsia in high risk population: randomised controlled trial. BMJ. 2011 May 19;342:d2901. doi: 10.1136/bmj.d2901.
PMID: 21596735DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Felipe Vadillo-Ortega, M.D.,Ph.D.
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
May 4, 2007
First Posted
May 7, 2007
Study Start
January 1, 2001
Study Completion
November 1, 2006
Last Updated
May 8, 2007
Record last verified: 2007-04