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A randomised controlled trial of vitamins C and E to prevent pre-eclampsia in type one diabetic pregnancy
ISRCTN ISRCTN27214045
DOI 10.1186/ISRCTN27214045
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised controlled trial of vitamins C and E to prevent pre-eclampsia in type one diabetic pregnancy
Scientific title
Acronym DAPIT- the Diabetes And Pre-eclampsia Intervention Trial
Serial number at source 067028
Study hypothesis Double-blind randomised multicentre placebo-controlled trial of Vitamin C 1000 mg and Vitamin E 400 IU or placebo tablets daily from eight to 22 weeks gestation until delivery to determine whether supplementation with vitamin C and vitamin E from early pregnancy will reduce the risk of developing pre-eclampsia in pregnant women with type one diabetes.

Please note that as of 11/06/2008, recruitment has closed on the 31/05/2008 and the end of follow-up will be on 31/01/2009. The previous end dates of this trial were 31/10/2007 (end of recruitment) and 30/09/2007 (end of follow-up).
Lay summary Background and study aims
Women with type 1 diabetes are up to four times more likely to develop high blood pressure during pregnancy (pre-eclampsia) when compared to a woman without diabetes. A recent study suggested that taking vitamin C and Vitamin E supplements may prevent women from developing pre-eclampsia, but this needs to be confirmed in larger studies. This is a study to find out if taking vitamin E and vitamin C supplements during pregnancy can prevent pre-eclampsia in women who have type 1 diabetes.

Who can participate?
The DAPIT study aims to recruit about 756 women with type 1 diabetes, over 16 years of age, from NHS antenatal-metabolic clinics across Northern Ireland, North West England and Scotland.

What does the study involve?
Women who take part in the study will be given 2 capsules to take each day throughout pregnancy. These may contain vitamin C and vitamin E or may be dummy (placebo) capsules. Neither the woman nor the doctor looking after her will know whether she is receiving vitamins or dummy tablets. Half of the patients in the study will receive vitamins, and the other half will receive placebo. Women will attend antenatal clinic every 2 weeks throughout pregnancy as normal, will be asked to complete a short (15 minutes) questionnaire about their diet after 26 weeks of pregnancy, and an extra blood sample will be taken at the first visit and after 26 and 34 weeks of pregnancy to measure levels of vitamins and biochemical markers which may be linked to pre-eclampsia. After pregnancy, we would like to assess the health of the baby at a routine post-natal visit which will occur approximately 6 weeks after delivery. This assessment will include measurement of height, weight and head circumference and assessment of development as well as a normal clinical examination.

What are the possible benefits and risks of participating?
For women who receive vitamin C and vitamin E during the study, it is possible that their risk of developing pre-eclampsia may be reduced. However, we do not know if this is the case. The information we get from this study may help us to treat pregnant patients with diabetes better. In particular, it will allow us to decide in the future whether all pregnant women with diabetes should be recommended to take vitamin supplements or whether this is a waste of time. The main disadvantage of taking part in the study is the need to take two capsules once per day. In addition, women will be asked to complete an additional dietary questionnaire as described above and to provide three blood samples during the course of your pregnancy.

Where is the study run from?
Queen’s University Belfast and Belfast Health and Social Care Trust.

When is study starting and how long is it expected to run for?
Recruitment started in 2003 and ended in 2008.

Who is funding the study?
The Wellcome Trust.

Who is the main contact?
Professor David McCance, david.mccance@belfasttrust.hscni.net
Ethics approval Ethics approval received from the West Midlands Multi-centre Research Ethics Committee on the 9th September 2002 (ref: MREC/02/7/16).
Study design Double-blind randomised multicentre placebo-controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Pre-eclampsia
Participants - inclusion criteria Women with type one diabetes preceding pregnancy presenting before 22 weeks gestation
Participants - exclusion criteria 1. Warfarin treatment
2. Multiple pregnancy
3. Gestational diabetes
4. Current or previous (within the last six weeks) ingestion of preparations containing vitamin C (more than 500 mg/day) or vitamin E (200 IU/day)
Anticipated start date 01/06/2003
Anticipated end date 31/01/2009
Status of trial Completed
Patient information material
Target number of participants 756 - recruitment will close on 31/05/2008.
Interventions Vitamin C 1000 mg and vitamin E 400 IU or placebo daily from recruitment (eight to 22 weeks gestation) until delivery.
Primary outcome measure(s) Incidence of pre-eclampsia, measured after delivery
Secondary outcome measure(s) 1. Endothelial activation, measured at baseline, 26 weeks gestation and 34 weeks gestation
2. Birthweight centile, measured after delivery
Sources of funding The Wellcome Trust (UK) (grant ref: 067028)
Trial website http://www.qub.ac.uk/cm/med/DAPITfrontpage.htm
Publications 1. 2004 protocol at: http://www.ncbi.nlm.nih.gov/pubmed/15464786
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20580423
Contact name Dr  David  McCance
  Address Regional Centre for Endocrinology and Diabetes
Royal Victoria Hospital
The Royal Group of Hospitals and Dental Hospital Health and Social Services Trust
Grosvenor Road
  City/town Belfast
  Zip/Postcode BT12 6BA
  Country United Kingdom
  Tel +44 (0)28 9063 3430
  Fax +44 (0)28 9031 0111
  Email david.mccance@royalhospitals.n-i.nhs.uk
Sponsor The Royal Group of Hospitals and Dental Hospital Health and Social Services Trust (UK)
  Address Royal Research Office
First Floor, Education Centre
Royal Victoria Hospital
Grosvenor Road
  City/town Belfast
  Zip/Postcode BT12 6BA
  Country United Kingdom
  Sponsor website: http://www.royalhospitals.org/
Date applied 25/11/2003
Last edited 29/11/2012
Date ISRCTN assigned 31/03/2004
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