The contribution of health services in reducing chronic malnutrition in children infected by intestinal parasites in Bengo Province, Angola

• Register: ISRCTN
• Last refreshed on: 20 June 2023
• Main ID: ISRCTN72928001
• Date of registration: 07/04/2017
• Prospective Registration: No
• Primary sponsor: Centro de Investigação em Saúde de Angola - CISA (Health Research Centre of Angola)
• Public title: The contribution of health services in reducing chronic malnutrition in children infected by intestinal parasites in Bengo Province, Angola
• Scientific title: The contribution of health services in reducing chronic malnutrition in children between two and five years of age: a community case study of infection by intestinal parasites in the province of Bengo, Angola
• Date of first enrolment: 17/12/2013
• Target sample size: 450
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN72928001
• Study type: Interventional
• Study design: Single-centre prospective four-arm randomised parallel trial (Treatment)
• Phase: Not Specified

Countries of recruitment

Angola

Contacts

• Name: Miguel Brito

• Name: Carolina Gasparinho

Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion criteria of children:
1. Age between 20-36 months at the recruitment period
2. Residents in the Dande Health and Demographic Surveillance System study area
3. No history of antibiotherapy in the previous 10 days
4. Children infected with at least one pathogenic intestinal parasite
5. Informed consent signed by parents or primary caregivers

Inclusion criteria of household members (arm 2 and 4):
After permission of the caregiver for child to participate in the study, arms 2 and 4 preview the inclusion of all the members of the household. Written Informed consent is required.

Exclusion criteria:
Exclusion criteria of children:
1. Age under 20 months or above 36 months
2. Children whom parents or primary caregivers do not reside in the Dande Health – and Demographic Surveillance System study area
3. Children with history of antibiotherapy or antiparasitic drug in the previous 10 days that can lead to false negatives in microscopic identification of pathogenic intestinal parasites
4. Children who are not infected with pathogenic intestinal parasites (protozoa and/or helminths)
5. Children whom parent or primary caregivers do not intend to participate in the study

Exclusion criteria for household members (arm 2 and 4):
1. Any person who does not live in the same household of the child included in the study
2. Household member who do not intend to participate in the study


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

1. Chronic malnutrition 2. Infection by pathogenic intestinal parasites
Infections and Infestations
1. Chronic malnutrition 2. Infection by pathogenic intestinal parasites

Intervention(s)

After being included in the study, caregivers will be asked about registration name, house name and age of all members of the household, as well as the neighbor of residence and contacts information. A study card of the child will be provided to caregivers with the schedule of all community follow-up (FU1-FU6) and information concerning assessment parameters of each follow-up, according to the arm of the study that the child was included, and the telephone contact of the coordinator of the study. As many streets do not have a name, to find the house of each participant a geographic coordinate provided by the HDSS will be used along with a point request near the house provided by caregivers. Each follow-up will be carried out by a team composed by a nurse, a clinical analysis technician and a motorist that moves by car to the house where the child lives and assessment will be done in the presence of the caregivers.

Arm 1:
Child: A single dose of albendazole 400mg will be provided to each child in the follow-up 1 and follow-up 4. Besides, nutritional assessment, anemia and malaria diagnosis will be performed during all follow-up visits.

Arm 2:
Child: A single dose of albendazole 400mg will be provided to each child included in the study in the follow-up 1 and follow-up 4. Besides, nutritional assessment, anemia and malaria diagnosis will be performed during all follow-up visits.
Member of the household: A dose of albendazol will be provided to members of the household: 200mg single dose for those between 12 and 24 months and 400mg single dose for those above 24 months of age. Albendazol will not be provided to pregnant women and those that breastfeed their babies.

Primary Outcome(s)

1. Linear growth of children is assessed by mean change in height-for-age Zscores from baseline to 4, 8, 12, 16, 20 and 24 months of follow-up period
2. Improvement of weight for height is assessed by mean change in weight-for-height Zscores from baseline to 4, 8, 12, 16, 20 and 24 months of follow-up period
3. Improvement of weight for age of children is assessed by mean change in weight-for-age Zscores from baseline to 4, 8, 12, 16, 20 and 24 months of follow-up period

Secondary Outcome(s)

1. Occurrence of infection by intestinal protozoa and helminths measured using stool sample analysis (direct examination with saline and iodine, a concentration method using Parasite Recovery System, kato-katz and kinyoun staining for coccidea diagnosis) from the baseline to 4, 8, 12, 16, 20 and 24 months of follow-up period
2. Occurrence of malaria measured using blood sample analysis from the baseline to 4, 8, 12, 16, 20 and 24 months of follow-up period
3. Improvement of anemia is assessed by mean change in haemoglobin (g/dl) from 4, 8, 12, 16, 20 and 24 months of follow-up period

Secondary ID(s)

N/A

Source(s) of Monetary Support

Fundação para a Ciência e Tecnologia, Portugal (Foundation for Science and Technology Portugal), Fundação Calouste Gulbenkian (Calouste Gulbenkian Foundation), Programa de Controlo da Malária do Ministério da Saúde de Angola - MINSA (National Malaria Control Program, Ministry of Health, Angola)

Secondary Sponsor(s)

Instituto de Higiene e Medicina Tropical

Ethics review

Status:
Approval date:
Contact:

1. Ethics Committee of the Angolan Ministry of Health, 01/11/2013 2. Ethics Committee of the Instituto de Higiene e Medicina Tropical, Portugal 28/10/2014, ref: 13-2013-TD

Results

• Results available: Yes
• Date Completed: 27/01/2017