Effect of repeated four-monthly albendazole treatments on malaria in pre-school children living in communities endemic for Ascaris lumbricoides: a double-blind placebo-controlled randomised trial
| ISRCTN | ISRCTN44215995 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44215995 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/07/2008
- Registration date
- 25/09/2008
- Last edited
- 16/04/2010
- 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 Celia Holland
Scientific
Scientific
Department of Zoology
The University of Dublin
Trinity College
Dublin
02
Ireland
Study information
| Study design | Double-blind placebo-controlled randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Deworming does not increase the incidence of malaria or the frequency of malaria attacks in pre-school children. |
| Ethics approval(s) | The Ethics and Research Committee of Obafemi Awolowo University Teaching Hospitals' Complex (Nigeria) gave approval on the 13th April 2006 (ref: ERC/2006/03/16) |
| Health condition(s) or problem(s) studied | Malaria, helminth parasitisation |
| Intervention | There were two groups: the treatment (albendazole) group and the placebo group. A dose of 200 mg (one tablet) of albendazole was given to children aged 1 year. A dose of 400 mg (two tablets) of albendazole was given to children aged 2, 3 and 4 years. Children who were in the placebo group and aged 1 year were given one placebo tablet and children aged 2, 3 and 4 years were given two placebo tablets. Children were given treatment or placebo at baseline, 4, 8 and 12 months and then followed up for the last time at 14 months. Children in the placebo group were treated with albendazole at 14 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Albendazole |
| Primary outcome measure | 1. Incidence of malaria, measured at baseline and 4, 8, 12 and 14 months 2. Malaria attacks, measured at baseline and 4, 8, 12 and 14 months 3. Infection with soil-transmitted helminths, measured at baseline and 4, 8, 12 and 14 months |
| Secondary outcome measures | 1. Nutritional status, measured at baseline and 14 months 2. Haemoglobin, measured at baseline and 4, 8, 12 and 14 months |
| Overall study start date | 16/05/2006 |
| Completion date | 22/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Months |
| Upper age limit | 59 Months |
| Sex | Both |
| Target number of participants | 1055 |
| Key inclusion criteria | Pre-school children aged 12 - 59 months, either sex |
| Key exclusion criteria | 1. Severe anaemia less than 5 g/dl 2. Severe malaria |
| Date of first enrolment | 16/05/2006 |
| Date of final enrolment | 22/08/2007 |
Locations
Countries of recruitment
- Ireland
- Nigeria
Study participating centre
Department of Zoology
Dublin
02
Ireland
02
Ireland
Sponsor information
The University of Dublin (Ireland)
University/education
University/education
Trinity College
Dublin
02
Ireland
| Website | http://www.tcd.ie/ |
|---|---|
"ROR" |
https://ror.org/05m7pjf47 |
Funders
Funder type
Government
Health Research Board (HRB) (Ireland)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- HRB
- Location
- Ireland
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | anthelmintic results | 19/02/2009 | Yes | No |
