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

ISRCTN ISRCTN62368611
DOI https://doi.org/10.1186/ISRCTN62368611
Secondary identifying numbers N/A
Submission date
08/10/2003
Registration date
17/11/2003
Last edited
12/06/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Lucilla Poston
Scientific

Division of Reproduction, Endocrinolgy & Diabetes
10th Floor North Wing
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Phone +44 (0)20 7188 3641
Email lucilla.poston@kcl.ac.uk

Study information

Study designMulticentre double-blind randomised placebo-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Patient information can be found on the website at: http://www.medscinet.com/vip/
Scientific titleA randomised controlled trial of vitamin C and E supplementation to prevent pre-eclampsia in women at risk
Study acronymVIP - The Vitamins In Pre-eclampsia Trial
Study objectivesA small study undertaken by the research team at St Thomas' Hospital in London, suggested that vitamins may help prevent pre-eclampsia. We asked a group of pregnant women, known to be at high risk of developing pre-eclampsia, to take vitamin C and vitamin E, or placebos (dummy tablets) from about 16 weeks of pregnancy until they had their babies. Neither the women nor the researchers knew who had the vitamins and who had the look alike tablets. We found that the women who had the vitamins were less likely to develop pre-eclampsia. However this was a very small project, and it is important that we know for certain whether these vitamins help protect women from pre-eclampsia, without causing any harm to the baby.

The hypothesis of this trial is:
Does antioxidant supplementation prevent the incidence of pre-eclampsia in women with identified risk factors?

Please note that the anticipated end date of this trial was brought forward to 01/12/2005.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPre-eclampsia
InterventionVitamin C 1000mg and vitamin E 400IU or placebo daily from recruitment (14-22 weeks gestation) until delivery.
Intervention typeSupplement
Primary outcome measure1. Incidence of pre-eclampsia
2. Birthweight
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/08/2003
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants2400
Key inclusion criteriaWomen 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
Key exclusion criteria1. Inability/unwillingness to give informed consent
2. Women taking warfarin (due to the theoretical potentiation of warfarin by Vitamin E)
Date of first enrolment01/08/2003
Date of final enrolment29/04/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

St Thomas' Hospital
London
SE1 7EH
United Kingdom

Sponsor information

King's College London (UK)
Hospital/treatment centre

The Guy's, King's and St Thomas' Hospitals' Medical and Dental School
James Clerk Maxwell Building
57 Waterloo Road
London
SE1 8WA
England
United Kingdom

Website http://www.kcl.ac.uk
ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

Charity

Wellcome Trust (UK) (grant ref: ALPOSTON 069056)
Private sector organisation / International organizations
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 08/04/2006 Yes No