Prenatal iron supplementation versus iron supplementation plus deworming in reducing low birthweight in hookworm-endemic areas

ISRCTN	ISRCTN08446014
DOI	https://doi.org/10.1186/ISRCTN08446014
Secondary identifying numbers	MCT-53575

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Theresa W Gyorkos
Scientific

Division of Clinical Epidemiology
V Building, Royal Victoria Hospital Campus
687 Pine Ave. West
Montreal
H3A 1A4
Canada

Phone	+1 514 934 1934 ext. 44721
Email	theresa.gyorkos@mcgill.ca

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Reducing low birthweight in hookworm-endemic areas: a randomised controlled trial (RCT) of prenatal iron versus iron plus mebendazole
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure	Mean infant birth weight
Secondary outcome measures	Change in maternal haemoglobin between baseline and delivery
Overall study start date	01/04/2003
Completion date	01/06/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	1042
Key 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
Key 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
Date of first enrolment	01/04/2003
Date of final enrolment	01/06/2004

Division of Clinical Epidemiology

Montreal
H3A 1A4
Canada

Montreal General Hospital (Canada)
Hospital/treatment centre

1650 Cedar Ave
Montreal
H3G 1A4
Canada

Website	http://www.muhc.ca/
"ROR"	https://ror.org/04gbhgc79

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-53575)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2005		Yes	No
Results article	results	01/10/2006		Yes	No