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A randomised controlled trial of vitamin C and E supplementation to prevent pre-eclampsia in women at risk

A randomised controlled trial of vitamin C and E supplementation to prevent pre-eclampsia in women at risk

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN62368611
Enrollment
2400
Registered
2003-11-17
Start date
2003-08-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-eclampsia Pregnancy and Childbirth Pre-eclampsia

Interventions

Vitamin C 1000mg and vitamin E 400IU or placebo daily from recruitment (14-22 weeks gestation) until delivery.

Sponsors

King's College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Women with identified additional risk factors for pre-eclampsia in ten geographical areas, and 22 hospitals through England: 1. Pregnant women between 14 and 22 weeks' gestation 2. A history of pre-eclampsia (requiring delivery less than 37 weeks) in preceding pregnancy, eclampsia or Haemolysis, Elevated Liver enzyme levels and Low Platelet count (HELLP) syndrome (at any time) 3. Women with essential hypertension, diabetes (requiring treatment), Systemic Lupus Erythrematosus (SLE)/Anti-Phospholipid antibody Syndrome (APS) with renal imvolvement 4. In the current pregnancy: abnormal uterine artery Dopplers (18 to 22 weeks), multiple pregnancy, diastolic Blood Pressure (BP) more than 90 mmHg (before 20 weeks) 5. Primparous women with Body Mass Index (BMI) more than 30

Exclusion criteria

Exclusion criteria: 1. Inability/unwillingness to give informed consent 2. Women taking warfarin (due to the theoretical potentiation of warfarin by Vitamin E)

Design outcomes

Primary

MeasureTime frame
1. Incidence of pre-eclampsia 2. Birthweight

Secondary

MeasureTime frame
No secondary outcome measures

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026