L-Arginine and Antioxidant Vitamins During Pregnancy to Reduce Preeclampsia

This study has been terminated.
(Recruitment and follow-up has been completed.)
Sponsor:
Collaborators:
University of Pennsylvania
Bill and Melinda Gates Foundation
Information provided by:
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
ClinicalTrials.gov Identifier:
NCT00469846
First received: May 4, 2007
Last updated: May 7, 2007
Last verified: April 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   19 Years to 32 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Additional 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
Study First Received: May 4, 2007
Last Updated: May 7, 2007
Health Authority: United States: Federal Government
Mexico: Ministry of Health

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

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

ClinicalTrials.gov processed this record on April 16, 2014