A randomised controlled trial of vitamins C and E to prevent pre-eclampsia in type one diabetic pregnancy

ISRCTN	ISRCTN27214045
DOI	https://doi.org/10.1186/ISRCTN27214045
Secondary identifying numbers	067028

Submission date: 25/11/2003
Registration date: 31/03/2004
Last edited: 19/06/2015

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

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 the 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 (UK).

Who is the main contact?
Professor David McCance
david.mccance@belfasttrust.hscni.net

Study website

Contact information

Dr David McCance
Scientific

Regional Centre for Endocrinology and Diabetes
Royal Victoria Hospital
The Royal Group of Hospitals and Dental Hospital Health and Social Services Trust
Grosvenor Road
Belfast
BT12 6BA
United Kingdom

Phone	+44 (0)28 9063 3430
Email	david.mccance@royalhospitals.n-i.nhs.uk

Study information

Study design	Double-blind randomised multicentre placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title	A randomised controlled trial of vitamins C and E to prevent pre-eclampsia in type one diabetic pregnancy
Study acronym	DAPIT- the Diabetes And Pre-eclampsia Intervention Trial
Study objectives	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. On 11/06/2008 the overall trial end date was changed from 30/09/2007 to 31/01/2009.
Ethics approval(s)	West Midlands Multi-centre Research Ethics Committee, 09/09/2002, ref: MREC/02/7/16
Health condition(s) or problem(s) studied	Pre-eclampsia
Intervention	Vitamin C 1000 mg and vitamin E 400 IU or placebo daily from recruitment (eight to 22 weeks gestation) until delivery.
Intervention type	Supplement
Primary outcome measure	Incidence of pre-eclampsia, measured after delivery
Secondary outcome measures	1. Endothelial activation, measured at baseline, 26 weeks gestation and 34 weeks gestation 2. Birthweight centile, measured after delivery
Overall study start date	01/06/2003
Completion date	31/01/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	756
Key inclusion criteria	Women with type one diabetes preceding pregnancy presenting before 22 weeks gestation
Key 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)
Date of first enrolment	01/06/2003
Date of final enrolment	31/05/2008

Locations

Countries of recruitment

Northern Ireland
United Kingdom

Study participating centre

Regional Centre for Endocrinology and Diabetes

Belfast
BT12 6BA
United Kingdom

Sponsor information

The Royal Group of Hospitals and Dental Hospital Health and Social Services Trust (UK)
Hospital/treatment centre

Royal Research Office
First Floor, Education Centre
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
Northern Ireland
United Kingdom

Website	http://www.royalhospitals.org/
"ROR"	https://ror.org/02tdmfk69

Funders

Funder type

Charity

Wellcome Trust
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	Peer reviewed?	Patient-facing?
Protocol article	protocol at:	01/10/2004	Yes	No
Results article	results	24/07/2010	Yes	No
Results article	results	01/01/2015	Yes	No