Plain English 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 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
Trial website
Contact information
Type
Scientific
Primary contact
Dr David McCance
ORCID ID
Contact details
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
+44 (0)28 9063 3430
david.mccance@royalhospitals.n-i.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
067028
Study information
Scientific title
A randomised controlled trial of vitamins C and E to prevent pre-eclampsia in type one diabetic pregnancy
Acronym
DAPIT- the Diabetes And Pre-eclampsia Intervention Trial
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.
On 11/06/2008 the overall trial end date was changed from 30/09/2007 to 31/01/2009.
Ethics approval
West Midlands Multi-centre Research Ethics Committee, 09/09/2002, ref: MREC/02/7/16
Study design
Double-blind randomised multicentre placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Vitamin C 1000 mg and Vitamin E 400 IU
Primary outcome measures
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 trial start date
01/06/2003
Overall trial end date
31/01/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Women with type one diabetes preceding pregnancy presenting before 22 weeks gestation
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
756
Participant 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)
Recruitment start date
01/06/2003
Recruitment end date
31/05/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Regional Centre for Endocrinology and Diabetes
Belfast
BT12 6BA
United Kingdom
Sponsor information
Organisation
The Royal Group of Hospitals and Dental Hospital Health and Social Services Trust (UK)
Sponsor details
Royal Research Office
First Floor
Education Centre
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Wellcome Trust
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
1. 2004 protocol at: http://www.ncbi.nlm.nih.gov/pubmed/15464786
2. 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20580423
3. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25368104
Publication citations
-
Protocol at
Holmes VA, Young IS, Maresh MJ, Pearson DW, Walker JD, McCance DR, , The Diabetes and Pre-eclampsia Intervention Trial., Int J Gynaecol Obstet, 2004, 87, 1, 66-71, doi: 10.1016/j.ijgo.2004.06.015.
-
Results
McCance DR, Holmes VA, Maresh MJ, Patterson CC, Walker JD, Pearson DW, Young IS, , Vitamins C and E for prevention of pre-eclampsia in women with type 1 diabetes (DAPIT): a randomised placebo-controlled trial., Lancet, 2010, 376, 9737, 259-266, doi: 10.1016/S0140-6736(10)60630-7.
-
Results
Maresh MJ, Holmes VA, Patterson CC, Young IS, Pearson DW, Walker JD, McCance DR; Diabetes and Pre-eclampsia Intervention Trial Study Group, Glycemic targets in the second and third trimester of pregnancy for women with type 1 diabetes, Diabetes Care, 2015 , 38, 1, 34-42, doi: 10.2337/dc14-1755.