Condition category
Infections and Infestations
Date applied
09/09/2005
Date assigned
09/09/2005
Last edited
03/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.muhc.ca/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes