Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Lucilla Poston
ORCID ID
Contact details
Division of Reproduction
Endocrinolgy & Diabetes
10th Floor North Wing
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
+44 (0)20 7188 3641
lucilla.poston@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised controlled trial of vitamin C and E supplementation to prevent pre-eclampsia in women at risk
Acronym
VIP - The Vitamins In Pre-eclampsia Trial
Study hypothesis
A 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
Not provided at time of registration
Study design
Multicentre double-blind randomised placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Patient information can be found on the website at: http://www.medscinet.com/vip/
Condition
Pre-eclampsia
Intervention
Vitamin C 1000mg and vitamin E 400IU or placebo daily from recruitment (14-22 weeks gestation) until delivery.
Intervention type
Supplement
Phase
Not Specified
Drug names
Vitamin C 1000mg and vitamin E 400IU
Primary outcome measure
1. Incidence of pre-eclampsia
2. Birthweight
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/08/2003
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
2400
Participant exclusion criteria
1. Inability/unwillingness to give informed consent
2. Women taking warfarin (due to the theoretical potentiation of warfarin by Vitamin E)
Recruitment start date
01/08/2003
Recruitment end date
29/04/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Thomas' Hospital
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
The Guy's
King's and St Thomas' Hospitals' Medical and Dental School
James Clerk Maxwell Building
57 Waterloo Road
London
SE1 8WA
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Wellcome Trust (UK) (grant ref: ALPOSTON 069056)
Alternative name(s)
Wellcome
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16616557
Publication citations
-
Results
Poston L, Briley AL, Seed PT, Kelly FJ, Shennan AH, , Vitamin C and vitamin E in pregnant women at risk for pre-eclampsia (VIP trial): randomised placebo-controlled trial., Lancet, 2006, 367, 9517, 1145-1154, doi: 10.1016/S0140-6736(06)68433-X.