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
Contact information
Prof Lucilla Poston
Scientific
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 |
|---|---|
| lucilla.poston@kcl.ac.uk |
Study information
| Study design | Multicentre double-blind randomised placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Patient information can be found on the website at: http://www.medscinet.com/vip/ |
| Scientific title | A randomised controlled trial of vitamin C and E supplementation to prevent pre-eclampsia in women at risk |
| Study acronym | VIP - The Vitamins In Pre-eclampsia Trial |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pre-eclampsia |
| Intervention | Vitamin C 1000mg and vitamin E 400IU or placebo daily from recruitment (14-22 weeks gestation) until delivery. |
| Intervention type | Supplement |
| Primary outcome measure | 1. Incidence of pre-eclampsia 2. Birthweight |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/08/2003 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 2400 |
| Key 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 |
| Key exclusion criteria | 1. Inability/unwillingness to give informed consent 2. Women taking warfarin (due to the theoretical potentiation of warfarin by Vitamin E) |
| Date of first enrolment | 01/08/2003 |
| Date of final enrolment | 29/04/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Thomas' Hospital
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
King's College London (UK)
Hospital/treatment centre
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" |
https://ror.org/0220mzb33 |
Funders
Funder type
Charity
Wellcome Trust (UK) (grant ref: ALPOSTON 069056)
Private sector organisation / International organizations
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
