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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 30 June 2014
Main ID:  ISRCTN47196031
Date of registration: 07/09/2012
Primary sponsor: London School of Hygiene & Tropical Medicine (UK)
Public title: Lake Victoria Island Intervention Study on Worms and Allergy-related diseases LaVIISWA
Scientific title: Lake Victoria Island Intervention Study on Worms and Allergy-related diseases
Date of first enrolment: Sep 10 2012
Target sample size: The study will have two main surveys, a baseline survey and an outcome survey. At each main survey we aim to recruit a total of 3250 people from approximately 910 households.
Recruitment status: Ongoing/Recruiting
URL:  http://isrctn.org/ISRCTN47196031
Study type:  Interventional
Study design:  Cluster-randomised intervention trial  
Countries of recruitment
Uganda
Contacts
Name: Alison  Elliott
Address:  Medical Research Council/UVRI Uganda Research Unit on AIDS Nakiwogo Road - Entebbe Uganda
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Fishing camp villages in Koome sub-county, Mukono District, Uganda, will be eligible for inclusion. All households in participating villages will be eligible for inclusion in the surveys. In selected and participating households, all household members, of all ages, will be eligible for inclusion in the survey.
Exclusion criteria: 1. Villages will be excluded if their Local Council leaders refuse permission for them to participate
2. Households where all members refuse to participate, or where all members are absent during the survey period
3. Does not meet inclusion criteria


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Worm infections and their effects on general health and on allergy-related conditions
Intervention(s)
Standard intervention against helminths (as recommended by the Vector Control Division at the Ministry of Health) comprises single-dose albendazole (400 mg) given twice-yearly to all community members aged one year or above, and annual praziquantel treatment (at a dose of approximately 40 mg/kg, but estimated by a height pole) to all individuals whose height falls within the range on the height pole. This height range excludes pre-school children. This standard intervention will be compared with an intensive intervention comprising home-delivered, quarterly albendazole and praziquantel to all household members in the whole community, including preschool children.
Primary Outcome(s)
1. Wheeze
2. Atopy (assessed by allergen-specific serum IgE)
3. Atopy (assessed by skin prick test responses)
Secondary Outcome(s)
1. Eczema (visible flexural dermatitis)
2. Helminth infection prevalence
3. Haemoglobin
4. Height and weight z-scores
5. Hepatosplenomegaly
6. Vaccine responses
7. Cognitive function in children
Secondary ID(s)
N/A
Source(s) of Monetary Support
Wellcome Trust (UK) ref: 095778
Secondary Sponsor(s)
N/A
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