Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr William D. Fraser
ORCID ID
Contact details
Hôpital Sainte-Justine
Département d'Obstétrique-Gynécologie
3175
Chemin de la Côte-Ste-Catherine
4e Étage
Bloc 9
Local 4986-B
Montréal
H3T 1C5
Canada
+1 514 345 4931 ext. 4155
william.fraser@umontreal.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-62005
Study information
Scientific title
Antioxidants for the prevention of preeclampsia: a randomised controlled trial
Acronym
INTAPP
Study hypothesis
To determine whether daily supplementation of vitamin C and vitamin E reduce the incidence of gestational hypertension (with or without proteinuria) and its adverse conditions.
Ethics approval
Centre De Recherche De L'Hopital Sainte-Justine, Comité d'éthique de la recherche gave approval on the 1st December 2003.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Gestational hypertension with or without proteinuria (preeclampsia)
Intervention
Group One (Experimental): Daily supplementation with 1 g Vitamin C, 400 IU Vitamin E
Group Two (Control): Matching placebo
The duration of the follow-up varies for each participant. The woman is randomised between 12^0/7 to 18^6/7 weeks of pregnancy and she takes the medication daily until the date of delivery.
Trial details received: 12 Sept 2005
Intervention type
Supplement
Phase
Not Applicable
Drug names
Vitamin C, vitamin E
Primary outcome measures
Gestational hypertension, with or without proteinuria and adverse conditions. The data is recorded from the medical chart after post-partum hospital discharge. The period covered is: pregnancy, from randomisation to post-partum hospital discharge.
Secondary outcome measures
Outcome indicators are assessed from randomisation until post-partum hospital discharge. The following sources are used: prenatal record from treating MD, data recorded in CRF by study nurse at the three follow-up visits, postpartum and newborn hospital chart of mother and baby.
The period covered is: pregnancy, from randomisation to postpartum hospital discharge.
1. Preeclampsia
2. Maternal death
3. Severe preeclampsia
4. Preterm delivery less than 32 and less than 37 weeks gestation (gestational age corrected by early ultrasound scan)
5. Intrauterine growth restriction (less than third centile)
6. Perinatal mortality
7. Spontaneous abortion
8. Premature rupture of membranes
9. Antenatal inpatient days
10. Neonatal mortality indicators
Overall trial start date
15/01/2004
Overall trial end date
30/06/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. The woman is pregnant between 12^0/7 and 18^6/7 completed weeks
2. At least 18 years of age
3. Speaks a language known by the medical staff
4. Plans to deliver in a participating hospital
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
10000 low risk; 2500 high risk
Participant exclusion criteria
1. Daily Vitamin C intake equal or more than 200 mg
2. Daily Vitamin E intake equal or more than 50 IU
3. Uses warfarin (coumadin)
4. Known major foetal abnormalities, including chromosomal anomalies in the current pregnancy
5. Has one of the following conditions:
5.1. Untreated hypo/hyperthyroidism
5.2. Renal disease with altered renal function (creatinine more than two times the upper limit of the normal range value)
5.3. Any collagen vascular disease (including lupus erythromatosus, scleroderma)
5.4. Active or chronic hepatitis
5.5. Epilepsy
5.6. Cancer
5.7. Threatened abortion (the woman had two or more miscarriages)
5.8. Illicit drug use or alcohol abuse (more than or equal to two drinks a day during current pregnancy)
Recruitment start date
15/01/2004
Recruitment end date
30/06/2008
Locations
Countries of recruitment
Argentina, Belgium, Canada, China, Mexico
Trial participating centre
Hôpital Sainte-Justine
Montréal
H3T 1C5
Canada
Sponsor information
Organisation
Hospital Sainte-Justine (Montréal) (Canada)
Sponsor details
3175 Chemin Côte Ste-Catherine
Montréal
H3T 1C5
Canada
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-62005)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2005 interim results in http://www.ncbi.nlm.nih.gov/pubmed/15924519
Publication citations
-
Interim results
Fraser WD, Audibert F, Bujold E, Leduc L, Xu H, Boulvain M, Julien P, The vitamin E debate: implications for ongoing trials of pre-eclampsia prevention., BJOG, 2005, 112, 6, 684-688, doi: 10.1111/j.1471-0528.2005.00675.x.