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Note: This record shows only 22 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: 29 November 2021
Main ID:  ISRCTN18101157
Date of registration: 06/09/2016
Prospective Registration: No
Primary sponsor: Health Research Centre of Angola
Public title: Efficacy of community educational interventions in nutrition and WASH/Malaria in reducing anemia in children under five, in the municipality of Dande - Angola
Scientific title: Anemia and its preventable etiologic agents in pre-school children from Bengo, Angola
Date of first enrolment: 15/06/2015
Target sample size: 974
Recruitment status: Completed
URL:  https://www.isrctn.com/ISRCTN18101157
Study type:  Interventional
Study design:  Cluster randomized controlled trial (Prevention)  
Phase:  Not Applicable
Countries of recruitment
Angola
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Cláudia    Fançony
Address:  Apartado Central Postal de Luanda Apartado IV - nº 5547 5547 Luanda Angola
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria:
1. All children under 3 years old (and their primary caretakers)
2. Resident in hamlets with functional health posts within the communes of Ucua, Mabubas and Caxito from the Dande municipality (Bengo province, Angola)

Exclusion criteria:
1. Reported adverse reactions to albendazole and praziquantel
2. Failing the assessment and treatment at the baseline


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Anemia and its etiologic agents (malnutrition, micro-nutrient deficiency, malaria, schistosomiasis, STH, food security and socioeconomic conditions, etc).
Haematological Disorders
Anemia and its etiologic agents (malnutrition, micro-nutrient deficiency, malaria, schistosomiasis, STH, food security and socioeconomic conditions, etc).
Intervention(s)

After the baseline evaluation (for which all eligible children will be invited to participate by a mobilization team in a census approach), the names of the hamlets (clusters) will be written on a paper and placed in a bag. The papers will then be successively removed from the bag, where the first pair removed will be allocated to the nutrition arm, the following pair to the WASH/malaria arm and the next to the control group, and so on successively until there is only one hamlet to be removed (which will be allocated to the nutrition group).

Group A: Nutrition educational intervention - Personalized (theoretical), home-based counseling of primary caretakers on infant and young children and community cooking practical classes.

Group B: WASH and malaria prevention educational intervention - Personalized (theoretical), home-based counseling of primary caretakers on adequate WASH and malaria preventive behaviors and community washing-hands practical classes

Group C: Control group - In this group, children will be screened and treated for malaria, schistosomiasis and STH at the baseline and in the follow up evaluations.

Children from all arms will be screened and treated for malaria, schistosomiasis and STH at the baseline and in the follow up evaluations (every six months).
Primary Outcome(s)
Variation of hemoglobin levels during 12 months, measured in blood collected by venipuncture (by immunochromatography using an Hemocue 301+) at baseline, 6 and 12 months
Secondary Outcome(s)

1. Variation of anthropometric indices (weight and height, measured using platform/floor scales and infantometer/stadiometer, respectively) at baseline, 6 and 12 months
2. Micro-nutrient deficiency: ferritin, measured by turbidimetric/colorimetric techniques using an automated autoanalizer (BT1500) and folate, vitamin A and B12, measured by HPLC, in samples collected at baseline, 6 and 12 months
3. Food diversity, measured by questionnaire completed by the mothers/caretakers, at baseline, 6 and 12 months
Secondary ID(s)
N/A
Source(s) of Monetary Support
Calouste Gulbenkian Foundation (Fundação Calouste Gulbenkian), Banco de Fomento Angola (BFA), Special Program for Research and Training in Tropical Diseases (TDR), José Eduardo dos Santos Foundation (Fundação José Eduardo dos Santos)
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available: Yes
Date Posted:
Date Completed: 15/09/2017
URL:
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