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L-Arginine and Antioxidant Vitamins During Pregnancy to Reduce Preeclampsia (L-Arg)

This study has been terminated.
(Recruitment and follow-up has been completed.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00469846
First Posted: May 7, 2007
Last Update Posted: May 8, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Pennsylvania
Bill and Melinda Gates Foundation
Information provided by:
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
  Purpose
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.

Condition Intervention Phase
Pre-Eclampsia Procedure: L-arginine supplementation in a medical food Procedure: Vitamin C and E supplementation in a medical food Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Supplementation With L-Arginine and Antioxidant Vitamins During Pregnancy in a Medical Food to Reduce the Risk of Preeclampsia in a High Risk Population

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes:

Primary Outcome Measures:
  • Development of preeclampsia [ Time Frame: During pregnancy ]

Secondary Outcome Measures:
  • Development of eclampsia [ Time Frame: During pregnancy ]
  • Occurrence of HELP syndrome [ Time Frame: During pregnancy ]
  • Occurrence of preterm labor, preterm premature rupture of the membranes [ Time Frame: During pregnancy ]
  • Gestational age at delivery [ Time Frame: End of pregnancy ]

Enrollment: 585
Study Start Date: January 2001
Study Completion Date: November 2006
Detailed Description:

Preeclampsia is a syndrome of unknown origin characterized by hypertension, edema and proteinuria. It usually appears in the third trimester and occurs most frequently in primigravidas. Preeclampsia may be complicated by life-threatening conditions including seizures, severe hepatic dysfunction, renal failure and coagulopathy; it is one of the leading causes of maternal morbidity and mortality worldwide. Preeclampsia is cited as the leading cause of maternal death in surveys of maternal mortality in Mexico (25% of maternal deaths).

Specific Aim 1. 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. Two other groups will receive the food (bars) either with antioxidant vitamins alone or without vitamins in order to test the impact of vitamin supplements on prevention of preeclampsia. The primary hypothesis to be tested is that supplemental L-arginine in combination with antioxidant vitamins will significantly reduce preeclampsia (hypertension and proteinuria) and its complications in a high-risk population (women whose blood pressure is > 140/90 after 20 weeks gestation without proteinuria). Secondary hypotheses to be tested include that antioxidant vitamin supplementation contributes to the reduction in preeclampsia; that supplemental L-arginine and antioxidant vitamins will improve neonatal outcomes (reduced incidence of prematurity and intrauterine growth retardation); that preeclampsia is correlated inversely with plasma L-arginine levels, directly with the plasma levels of the endogenous NO synthase inhibitor, asymmetric dimethyl arginine (ADMA), and inversely with urinary NO metabolites, a marker of endogenous NO production; and that preeclampsia is inversely correlated with maternal plasma levels of antioxidant vitamins.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 32 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previous pregnancy complicated with pre-eclampsia/eclampsia
  • Singleton pregnancy
  • Gestational age >20 weeks <34 weeks
  • Protein excretion < 300 mg/day

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00469846


Locations
United States, Pennsylvania
Univesity of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-6142
Mexico
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Mexico City, D.f., Mexico, 11000
Sponsors and Collaborators
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
University of Pennsylvania
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Felipe Vadillo-Ortega, M.D.,Ph.D. Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00469846     History of Changes
Other Study ID Numbers: 212250-02071
First Submitted: May 4, 2007
First Posted: May 7, 2007
Last Update Posted: May 8, 2007
Last Verified: April 2007

Keywords provided by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes:
Pre-Eclampsia
Hypertension,pregnancy-induced
Preterm labor

Additional relevant MeSH terms:
Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Vitamins
Antioxidants
Micronutrients
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents


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