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 |
| Protocol serial number | MCT-53575 |
| Sponsor | Montreal General Hospital (Canada) |
| Funder | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-53575) |
- Submission date
- 09/09/2005
- Registration date
- 09/09/2005
- Last edited
- 03/03/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Theresa W Gyorkos
Scientific
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 |
|---|---|
| theresa.gyorkos@mcgill.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Mean infant birth weight |
| Key secondary outcome measure(s) |
Change in maternal haemoglobin between baseline and delivery |
| Completion date | 01/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Canada
- Peru
Study participating centre
Division of Clinical Epidemiology
Montreal
H3A 1A4
Canada
H3A 1A4
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| 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 |
