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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: Completed Phase 3 study, sponsored by The George Washington University Biostatistics Center.
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, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1217% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Severe hypertension (blood pressure \[BP\]\>= 160/110) or mild hypertension (BP\>= 140/90) \>= 20 weeks gestation in conjunction with one of the following: elevated liver enzymes, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, an indicated preterm birth before 32 weeks of gestation owing to hypertension-related disorders, a fetus that was small for gestational age (below 3rd percentile) adjusted for sex and race or ethnic group, fetal death after 20 weeks of gestation, or
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 |
What the finished NCT00135707 record still lists
NCT00135707 is an interventional study that assigns participants to a tested intervention. Its 10,154 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1217% higher).
The record links to 0 conditions, and to 2 interventions - of which Dietary Supplement/Vitamins is the first listed.
NCT00135707 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00135707's enrollment target sits among peer trials
10,154 27th of 2000 higher than 1,974 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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