Effectiveness of Local Food Solutions for the Prevention of Acute Malnutrition in Tigray, Northern Ethiopia (ELOFSAM)

NCT06103084 | Unknown

• 1 other identifier: MUCHS
• Study Type: interventional
• Target: 7,530
• Locations: 1 country
• Sites: 1

Brief Summary

The lack of diversified and enriched complementary foods is one of the key causes of the high burden of acute malnutrition among 6-23 months old children in Ethiopia. Thus, a new innovative way of diversifying and enriching complementary foods is essential in communities where vulnerable populations are likely to have nutrient gaps in their typical diets and multiple micronutrient deficiencies. The purpose of this project is to investigate the acceptability and effectiveness of locally produced cereal based foods (LP-CBFs) and small quantity lipid based nutrient supplements (SQ-LNS) as preventive interventions to effectively reduce the burden of acute malnutrition among 6-23 months old children in the post conflict settings of Tigray, Northern Ethiopia.

Conditions

Acute Malnutrition in Childhood

Outcome Measures

Primary Outcomes (1)

• Acute Malnutrition

  The burden or prevalence of acute malnutrition among 6-23 months old children.

  six months

Study Arms (3)

Bahgina group

EXPERIMENTAL

The Bahgina treatment group will be supplemented with Bahgina, a locally produced cereal based product for a maximum of six months at 200g/day.

Dietary Supplement: Bahgina

SQLNS group

EXPERIMENTAL

The small quantity lipid based nutrient supplements (SQLNS) group will be provided with 20g of SQLNS/day for a maximum of six months.

Dietary Supplement: SQLNS

Control

NO INTERVENTION

The control group will get nothing except the routine nutrition services and products provided by the local government sectors.

Interventions

Bahgina DIETARY_SUPPLEMENT

Bahgina, a locally produced cereal based food, will be provided at 200g/day/child for a duration of six months on top of the routine nutrition services provided by the local government and nutrition partners.

Bahgina group

SQLNS DIETARY_SUPPLEMENT

Small quantity lipid based nutrient supplement (SQ-LNS) will be provided at 20g/day/child for a duration of six months on top of the routine nutrition services provided by the local government and nutrition partners.

SQLNS group

Eligibility Criteria

• Age: 6 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All 6-23 months old children

You may not qualify if:

• months old children with severe acute malnutrition.

Sponsors & Collaborators

• Mekelle University: lead
• Tigray Development Association: collaborator
• Mums for Mums: collaborator
• Tigray Health Research Institute: collaborator
• Tigray Health Bureau: collaborator
• UNICEF Tigray Office: collaborator

Study Sites (1)

Tigray Health Research Institute

Mek'ele, Tigray, 1547, Ethiopia

RECRUITING

Study Officials

• Hayelom Kahsay, MD

  Tigray Health Research Institute

  STUDY CHAIR

Central Study Contacts

Afework Mulugeta, PhD

CONTACT

+251 914 382045; afework.mulugeta@gmail.com

Kidanemariam Alem, MSc

CONTACT

+251921645753; kidanemariam2012@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 26, 2023
• Study Start: June 30, 2023
• Primary Completion: December 30, 2023
• Study Completion: February 28, 2024
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

ET (1)