Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS)
Public ClinicalTrials.gov record NCT00135707. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Clinical Trial of Antioxidants to Prevent Preeclampsia and An Observational Cohort Study to Predict Preeclampsia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT00135707
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 10,154 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2003
- Primary completion
- Sep 30, 2008
- Completion
- Dec 31, 2008
- Last update posted
- Feb 20, 2019
2003 – 2009
United States locations
- U.S. sites
- 16
- U.S. states
- 11
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama - Birmingham | Birmingham | Alabama | 35233 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Wayne State University | Detroit | Michigan | 48201 | — |
| Columbia University | New York | New York | 10032 | — |
| University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | — |
| Case Western University | Cleveland | Ohio | 44109 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Oregon Health and Sciences University | Portland | Oregon | 97239 | — |
| Drexel University | Philadelphia | Pennsylvania | 19107 | — |
| University of Pittsburgh Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | — |
| Brown University | Providence | Rhode Island | 02905 | — |
| University of Texas - Southwest | Dallas | Texas | 75235 | — |
| University of Texas Medical Branch | Galveston | Texas | 77555 | — |
| University of Texas - Houston | Houston | Texas | 77030 | — |
| University of Utah Medical Center | Salt Lake City | Utah | 84132 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00135707, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 20, 2019 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00135707 live on ClinicalTrials.gov.