Main
|
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: |
|
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
|
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)
|
Ethics review
|
Status:
Approval date:
Contact:
|
Results
|
Results available:
|
Yes |
Date Posted:
|
|
Date Completed:
|
15/09/2017 |
URL:
|
|
|
|