A cluster-randomised study of the effect of albendazole treatment on the prevalence of childhood atopy among children with geohelminth infections
| ISRCTN | ISRCTN61195515 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61195515 |
| Secondary identifying numbers | 060120 |
- Submission date
- 17/12/2005
- Registration date
- 21/12/2005
- Last edited
- 21/03/2013
- 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
Dr Philip Cooper
Scientific
Scientific
Hospital Pedro Vicente Maldonado
Casilla 17-14-30
Carcelen
Quito
-
Ecuador
| Phone | +593 (0)2 2470181 |
|---|---|
| pcooper@ecnet.ec |
Study information
| Study design | Cluster-randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Geohelminth infections suppress atopy in children and this suppression is reversible by anthelmintic treatment. |
| Ethics approval(s) | Approval received from: 1. St George's Hospital London (UK) 2002 2. Hospital Pedro Vicente Maldonado (Ecuador) 2002 |
| Health condition(s) or problem(s) studied | Geohelminth infections |
| Intervention | Bimonthly albendazole (400 mg) for 12 months (total of seven treatments) versus no intervention. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Albendazole |
| Primary outcome measure | Atopy (measured by allergen skin test reactivity) |
| Secondary outcome measures | 1. Allergic symptoms 2. Exercise-induced bronchospasm 3. Flexural dermatitis |
| Overall study start date | 15/06/2002 |
| Completion date | 01/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 68 schools; ~2,730 children |
| Key inclusion criteria | Schools: 1. Access during rainy season 2. Total size less than 150 children 3. Preliminary meetings attended by a majority of parents Individuals: 1. Healthy children in second to seventh year of primary education (i.e. aged eight to 14 years) 2. Informed written consent by a parent |
| Key exclusion criteria | Schools: 1. Limited access during rainy season 2. Total size more than 150 children 3. Preliminary meetings attended by minority of parents Individuals: 1. Children not in second to seventh year of primary education 2. No informed written consent by a parent |
| Date of first enrolment | 15/06/2002 |
| Date of final enrolment | 01/09/2004 |
Locations
Countries of recruitment
- Ecuador
Study participating centre
Hospital Pedro Vicente Maldonado
Quito
-
Ecuador
-
Ecuador
Sponsor information
St George's Hospital Medical School (UK)
Hospital/treatment centre
Hospital/treatment centre
Cranmer Terrace
London
SW17 ORE
United Kingdom
| Website | http://www.sgul.ac.uk |
|---|---|
"ROR" |
https://ror.org/040f08y74 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 060120)
No information available
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 | Results | 13/05/2006 | Yes | No |
