Contact information
Type
Scientific
Primary contact
Prof Theresa W Gyorkos
ORCID ID
Contact details
Division of Clinical Epidemiology
V Building
Royal Victoria Hospital Campus
687 Pine Ave. West
Montreal
H3A 1A4
Canada
+1 514 934 1934 ext. 44721
theresa.gyorkos@mcgill.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-53575
Study information
Scientific title
Reducing low birthweight in hookworm-endemic areas: a randomised controlled trial (RCT) of prenatal iron versus iron plus mebendazole
Acronym
Study hypothesis
To determine the effectiveness of mebendazole plus iron supplements versus placebo plus iron supplements on infant birthweight and maternal anaemia, in pregnant women living in a hookworm-endemic area.
Please note that as of 03/03/2009 the anticipated start and end dates in this record were amended. The previous dates are as follows:
Initial anticipated start date: 01/01/2005
Initial anticipated end date: 31/12/2005
Ethics approval
1. MUHC-Montreal General Hospital Research Ethics Committee approved on the 8th March 2004
2. The Comite Institucional de Etica de la Universidad Peruana Cayetano Heredia (Peru)
3. The Comite Etica de la Direccion General de Salud de las Personas del MInisterio de Salud de Peru (Peru)
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
Anaemia, hookworm infection
Intervention
One dose of mebendazole (500 mg) or placebo similar to the mebendazole. Daily iron supplements (60 mg iron) to both groups.
Intervention type
Supplement
Phase
Not Applicable
Drug names
Mebendazole, iron supplementation
Primary outcome measures
Mean infant birth weight
Secondary outcome measures
Change in maternal haemoglobin between baseline and delivery
Overall trial start date
01/04/2003
Overall trial end date
01/06/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Second trimester pregnant women aged 18 to 44 years old
2. Not having received anthelmintic treatment for six months prior to randomisation
3. Consents to participate
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1042
Participant exclusion criteria
1. Women with severe anaemia (haemoglobin levels less than 80 g/I)
2. Women who have medical conditions for which follow-up is required
Recruitment start date
01/04/2003
Recruitment end date
01/06/2004
Locations
Countries of recruitment
Peru
Trial participating centre
Division of Clinical Epidemiology
Montreal
H3A 1A4
Canada
Sponsor information
Organisation
Montreal General Hospital (Canada)
Sponsor details
1650 Cedar Ave
Montreal
H3G 1A4
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-53575)
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
1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16222026
2. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17002722
Publication citations
-
Results
Larocque R, Casapia M, Gotuzzo E, Gyorkos TW, Relationship between intensity of soil-transmitted helminth infections and anemia during pregnancy., Am. J. Trop. Med. Hyg., 2005, 73, 4, 783-789.
-
Results
Larocque R, Casapia M, Gotuzzo E, MacLean JD, Soto JC, Rahme E, Gyorkos TW, A double-blind randomized controlled trial of antenatal mebendazole to reduce low birthweight in a hookworm-endemic area of Peru., Trop. Med. Int. Health, 2006, 11, 10, 1485-1495, doi: 10.1111/j.1365-3156.2006.01706.x.