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Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00135707 |
Preeclampsia is one of the most common complications of pregnancy and is characterized by high blood pressure and protein in the urine. This can cause problems in the second half of pregnancy for both the mother and fetus. This study of preeclampsia consists of two parts: 1) a randomized, placebo controlled, multicenter clinical trial of 10,000 low-risk nulliparous women between 9 and 17 weeks gestation and 2) an observational, cohort study of 4,000 patients between 9 and 12 weeks gestation who are also enrolled in the trial.
Subjects in both parts will receive either 1000 mg of vitamin C and 400 IU of vitamin E or matching placebo daily. The purpose of the randomized, clinical trial is to find out if high doses of vitamin C and E will reduce the risk of preeclampsia and other problems associated with the disease. The study will also evaluate the safety of antioxidant therapy for mother and infant. Patients will be seen monthly to receive their supply of study drug, to have weight and blood pressure recorded, to have urine protein measured, and to assess any side effects. At two visits, blood and urine will be collected.
The observational, cohort study will prospectively measure potential biochemical and biophysical markers that might predict preeclampsia. These patients will have additional procedures including uterine artery Doppler and blood drawn for a complete blood count (CBC).
Condition | Intervention | Phase |
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Preeclampsia |
Dietary Supplement: Vitamins C and E |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Clinical Trial of Antioxidants to Prevent Preeclampsia and An Observational Cohort Study to Predict Preeclampsia |
Enrollment: | 10154 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Dietary Supplement: Vitamins C and E
Vit C (500 mg) and Vit E (200 IU), two capsules daily between 9 - 17 weeks gestation. Placebo - two capsules daily between 9 - 17 weeks gestation. |
2: Placebo Comparator
Hydrogenated Vegetable Oil, Yellow wax, Lecithin, Mineral Oil, Soft Gelatin Shell
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Dietary Supplement: Vitamins C and E
Vit C (500 mg) and Vit E (200 IU), two capsules daily between 9 - 17 weeks gestation. Placebo - two capsules daily between 9 - 17 weeks gestation. |
A Randomized, Clinical Trial of Antioxidants to Prevent Preeclampsia:
Preeclampsia is the leading cause of maternal morbidity, as well as perinatal morbidity and mortality. Once the diagnosis has been established, therapy other than delivery has not been successful except to prolong pregnancy minimally (at some risk to mother and infant). Prevention efforts to reduce or eliminate preeclampsia are directed at the pathophysiology of the disorder prior to clinically evident preeclampsia and before irreversible changes have occurred.
This double-masked, placebo-controlled trial of 10,000 subjects is designed to evaluate the effects of antioxidant therapy in preventing serious complications associated with pregnancy-related hypertension in low risk, nulliparous women who begin treatment at 9-16 weeks gestation. The hypothesis being tested is that antioxidant therapy initiated prior to 16 weeks gestation will reduce the frequency of serious maternal and infant complications associated with pregnancy-related hypertension.
After randomization, subjects will receive either 1000 mg of vitamin C and 400 IU of vitamin E or matching placebo daily. They will be seen for monthly pill counts and to assess side effects, weight, blood pressure, and urine for protein. Blood and urine are collected at 24 and 32 weeks' gestation.
An Observational Cohort Study to Predict Preeclampsia:
A prospective, cohort study has been designed to complement the randomized, controlled, trial (RCT) and will test various biochemical and biophysical markers for ability to predict preeclampsia in 4,000 of the women who are enrolled in the RCT and are between 9 and 12 weeks gestation. These subjects will have additional procedures including a CBC and uterine artery Doppler.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
RCT Inclusion Criteria:
Observational Inclusion Criteria:
Exclusion Criteria RCT and Observational:
United States, Alabama | |
University of Alabama - Birmingham | |
Birmingham, Alabama, United States, 35233 | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 | |
United States, Michigan | |
Wayne State University | |
Detroit, Michigan, United States, 48201 | |
United States, New York | |
Columbia University | |
New York, New York, United States, 10032 | |
United States, North Carolina | |
University of North Carolina - Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Ohio | |
Ohio State University | |
Columbus, Ohio, United States, 43210 | |
Case Western University | |
Cleveland, Ohio, United States, 44109 | |
United States, Oregon | |
Oregon Health and Sciences University | |
Portland, Oregon, United States, 97239 | |
Oregon Health and Science University | |
Portland, Oregon, United States | |
United States, Pennsylvania | |
University of Pittsburgh Magee Womens Hospital | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Rhode Island | |
Brown University | |
Providence, Rhode Island, United States, 02905 | |
United States, Texas | |
University of Texas - Southwest | |
Dallas, Texas, United States, 75235 | |
University of Texas - Houston | |
Houston, Texas, United States, 77030 | |
The University of Texas Medical Branch | |
Galveston, Texas, United States, 77555 | |
University of Texas Medical Branch | |
Galveston, Texas, United States | |
United States, Utah | |
University of Utah Medical Center | |
Salt Lake City, Utah, United States, 84132 |
Study Director: | Catherine Spong, MD | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Principal Investigator: | Elizabeth A Thom, Ph.D. | George Washington University Biostatistics Center |
Responsible Party: | Pregnancy and Perinatology Branch, NICHD, NIH ( Catherine Y Spong, MD, Chief ) |
Study ID Numbers: | HD36801-CAPPS, HD21410, HD27869, HD27917, HD27860, HD27915, HD34116, HD34208, HD34136, HD40500, HD40485, HD40544, HD40545, HD40560, HD40512, HD36801 |
Study First Received: | August 24, 2005 |
Last Updated: | June 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00135707 |
Health Authority: | United States: Food and Drug Administration |
Antioxidants Preeclampsia Pregnancy Hypertension Pregnancy |
Tocopherols Tocopherol acetate Vitamin E Hypertension, Pregnancy-Induced Pregnancy Complications Eclampsia |
Pregnancy toxemia /hypertension Pre-Eclampsia Preeclampsia Ascorbic Acid Alpha-Tocopherol Hypertension |
Antioxidants Molecular Mechanisms of Pharmacological Action Growth Substances Vitamins |
Physiological Effects of Drugs Micronutrients Protective Agents Pharmacologic Actions |