This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Preeclampsia is one of the most common complications of pregnancy and remains a major cause of fetal and maternal morbidity and mortality. Recent clinical studies have suggested that daily antioxidant therapy may be of value in preventing preeclampsia and its associated complications. The purpose of this randomized clinical trial is to evaluate the effects of antioxidant therapy in preventing serious complications associated with pregnancy related hypertension in low risk, nulliparous women who begin treatment 9-16 weeks gestation. This study will also evaluate the safety of antioxidant therapy to mother and infant. The study is a randomized, placebo controlled multi-center clinical trial of 10,000 nulliparous women between 9 weeks 0 days and 16 weeks 6 days gestation. Women will be randomized to one of two groups: (1) Vitamin C (1000 mg) and Vitamin E (400 IU) or (2) matching placebo. Each patient will take two capsules daily. If an ultrasound examination has not been performed, one must be arranged prior to randomization for gestational age estimation. Each patient will be given a 7-day supply of placebo capsule in a single-blind manner. The patient must return within 14 days for a compliance check. Each woman will be seen monthly. Blood and urine will be collected at various visits. Blood from the umbilical cord will be collected after delivery. The neonate will have anthropometric obtained prior to discharge from the hospital

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000080-44
Application #
7378003
Study Section
Special Emphasis Panel (ZRR1-CR-1 (01))
Project Start
2006-04-01
Project End
2007-03-31
Budget Start
2006-04-01
Budget End
2007-03-31
Support Year
44
Fiscal Year
2006
Total Cost
$341,919
Indirect Cost
Name
Case Western Reserve University
Department
Type
Schools of Medicine
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
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Clark, Erin A S; Weiner, Steven J; Rouse, Dwight J et al. (2018) Genetic Variation, Magnesium Sulfate Exposure, and Adverse Neurodevelopmental Outcomes Following Preterm Birth. Am J Perinatol 35:1012-1022
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Inker, Lesley A; Grams, Morgan E; Levey, Andrew S et al. (2018) Relationship of Estimated GFR and Albuminuria to Concurrent Laboratory Abnormalities: An Individual Participant Data Meta-analysis in a Global Consortium. Am J Kidney Dis :
Juraschek, Stephen P; Miller 3rd, Edgar R; Appel, Lawrence J (2018) Orthostatic Hypotension and Symptoms in the AASK Trial. Am J Hypertens 31:665-671
Bustos, Martha L; Caritis, Steve N; Jablonski, Kathleen A et al. (2017) The association among cytochrome P450 3A, progesterone receptor polymorphisms, plasma 17-alpha hydroxyprogesterone caproate concentrations, and spontaneous preterm birth. Am J Obstet Gynecol 217:369.e1-369.e9
Chen, Teresa K; Appel, Lawrence J; Grams, Morgan E et al. (2017) APOL1 Risk Variants and Cardiovascular Disease: Results From the AASK (African American Study of Kidney Disease and Hypertension). Arterioscler Thromb Vasc Biol 37:1765-1769
Srinivasan, Lakshmi; Page, Grier; Kirpalani, Haresh et al. (2017) Genome-wide association study of sepsis in extremely premature infants. Arch Dis Child Fetal Neonatal Ed 102:F439-F445
Gibson, Kelly S; Stark, Sydney; Kumar, Deepak et al. (2017) The relationship between gestational age and the severity of neonatal abstinence syndrome. Addiction 112:711-716

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