Condition category
Pregnancy and Childbirth
Date applied
08/10/2003
Date assigned
17/11/2003
Last edited
12/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.medscinet.com/vip/

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 measures

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

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

http://www.kcl.ac.uk

Funders

Funder type

Charity

Funder name

Wellcome Trust (UK) (grant ref: ALPOSTON 069056)

Alternative name(s)

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

Results - basic reporting

Publication summary

2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16616557

Publication citations

  1. 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.

Additional files

Editorial Notes