Condition category
Haematological Disorders
Date applied
11/04/2016
Date assigned
06/09/2016
Last edited
06/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The infant death rate in Angola is one of the highest in the world, and anemia is thought to be a major cause. Anemia is a condition in which there are not enough red blood cells or not enough of the component of blood that binds to oxygen (hemoglobin). It is thought that a major cause of anemia is insufficient iron intake from the diet (an essential part of hemoglobin). Eating a diet lacking in vitamins and minerals can lead to nutritional anaemia, however infectious diseases such as malaria (an infectious disease caused by a microscopic parasite which is spread from person to person by mosquitos) or schistosomiasis (an infection caused by a parasitic worm that lives in tropical and subtropical countries). The aim of this study is to find out whether consuming a more nutrient-rich diet by eating a more varied diet can help reduce rates of malaria better than reducing parasitic infections through the use of infection preventive practices.

Who can participate?
All children under 3 years old and the person who looks after them, who live in hamlets within Ucua, Mabubas and Caxito from the Dande municipality (Bengo province, Angola)

What does the study involve?
Hamlets are randomly allocated into one of three groups. Those in the first group take part in an education program about eating a more varied diet so that they have more vitamins and minerals in their diet. Those in the second group take part in an education program about good hygiene practices and how to prevent infections. Those in the third group are tested and treated for infectious diseases (including malaria and schistosomiasis). Participants in all groups receive bednets, soap and lye (used for cleaning). At the start of the study and then after 6 and 12 months, participants in all groups have blood tests to check whether they are suffering from anaemia.

What are the possible benefits and risks of participating?
Participating children benefit from health monitoring and treatment for infectious diseases. Participants found to have sickle cell disease (a type of anaemia involving unusual shaped red blood cells which do not function properly) receive free-of-charge medication. Travel expenses can be provided. Bednets, bleach and soap will be distributed to all children. Additionally, counseling will improve household health. There is a small risk that families may find the tests to be time consuming. In addition, there is a small risk of pain, bruising and infection during blood testing.

Where is the study run from?
The study is run from the Health Research Center of Angola and takes place in Ucua, Mabubas and Caxito from the Dande municipality (Bengo province, Angola)

When is the study starting and how long is it expected to run for?
November 2014 to September 2017

Who is funding the study?
1. Calouste Gulbenkian Foundation (Angola)
2. Banco de Fomento Angola (Angola)
3. Special Program for Research and Training in Tropical Diseases (Angola)
4. José Eduardo dos Santos Foundation (Angola)

Who is the main contact?
1. Miss Cláudia Fançony (public)
2. Professor Miguel Brito (scientific)
miguel.brito@cisacaxito.org

Trial website

Contact information

Type

Scientific

Primary contact

Miss Cláudia Fançony

ORCID ID

http://orcid.org/0000-0003-4421-1769

Contact details

Apartado Central Postal de Luanda
Apartado IV - nº 5547
Luanda
5547
Angola

Type

Scientific

Additional contact

Prof Miguel Brito

ORCID ID

http://orcid.org/0000-0001-6394-658X

Contact details

Apartado Central Postal de Luanda
Apartado IV - nº 5547
Luanda
5547
Angola
+244 9427622
miguel.brito@cisacaxito.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Anemia and its preventable etiologic agents in pre-school children from Bengo, Angola

Acronym

Study hypothesis

Hypotheses
1. Educating mothers for adequate nutritional practices reduce anemia better than only deworming the children
2. Educating mothers for adequate Water, Sanitation and Hygiene practices reduce anemia better than only deworming the children
3. Educating mothers for adequate nutritional practices reduce anemia in children, better than educating mothers for adequate Water, Sanitation and Hygiene

Ethics approval

Ethics Committee of the Ministry of Health of the Republic of Angola, 10/06/2015

Study design

Cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Anemia and its etiologic agents (malnutrition, micro-nutrient deficiency, malaria, schistosomiasis, STH, food security and socioeconomic conditions, etc).

Intervention

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).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

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 measures

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

Overall trial start date

10/11/2014

Overall trial end date

15/09/2017

Reason abandoned

Eligibility

Participant 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)

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

There are 13 hamlets (clusters) with functional health posts registered within the area. Randomization may result in two arms with 4 clusters and one with 5 clusters. A density of 974 children in total are expected, however clusters are not expected to have the same density of eligible children.

Participant exclusion criteria

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

Recruitment start date

15/06/2015

Recruitment end date

15/09/2016

Locations

Countries of recruitment

Angola

Trial participating centre

Health Research Center of Angola
Estação Central Postal de Luanda. Apartado IV - nº 5547. Luanda - Angola
Caxito
5547
Angola

Sponsor information

Organisation

Health Research Centre of Angola

Sponsor details

Rua Direita
Caxito
9999
Angola
+244 9427622
info@cisacaxito.org

Sponsor type

Research organisation

Website

www.cisacaxito.org/

Funders

Funder type

Charity

Funder name

Calouste Gulbenkian Foundation (Fundação Calouste Gulbenkian)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Banco de Fomento Angola (BFA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Special Program for Research and Training in Tropical Diseases (TDR)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

José Eduardo dos Santos Foundation (Fundação José Eduardo dos Santos)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Planned publication of the study protocol, a paper on the etiologic agents of anemia and another comparing the effect of nutritional and WASH educational interventions on the occurrence of anemia, compared to the control group
2. Planned presentation in international congresses of public health or tropical medicine, within 2016 and 2017

Intention to publish date

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes