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NCT00135707 · ClinicalTrials.gov registry record · Phase 3
Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS)
A Phase 3 study, sponsored by The George Washington University Biostatistics Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 10,154
- Enrollment target
NCT00135707 is a Phase 3 study that has completed, run by The George Washington University Biostatistics Center. The registered enrollment target is 10,154 participants.
The verdict
NCT00135707, a Phase 3 study, has completed, sponsored by The George Washington University Biostatistics Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 10,154 participants
- Enrollment target
Study Summary
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 16 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).
Interventions
- DRUG Dietary Supplement/Vitamins
- DRUG Placebo for Vitamin C and Vitamin E
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,154 participants |
| Start Date | 2003-06 |
| Est. Completion | 2009-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00135707
The ClinicalTrials.gov registry entry for NCT00135707 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 10,154 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The George Washington University Biostatistics Center, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dietary Supplement/Vitamins is the first listed.
NCT00135707 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00135707 about?
NCT00135707 is a clinical study titled "Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS)". 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 co...
What is the current status of trial NCT00135707?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 10,154 participants. The study started on 2003-06. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00135707?
The interventions under investigation include: Dietary Supplement/Vitamins (DRUG), Placebo for Vitamin C and Vitamin E (DRUG).
Who is sponsoring clinical trial NCT00135707?
This trial is sponsored by The George Washington University Biostatistics Center, which has 24 total clinical trials registered on ClinicalTrials.gov.
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