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Clinical Trials/NCT06103084
NCT06103084RecruitingNot Applicable

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

Mekelle University1 site in 1 country7,530 target enrollmentStarted: June 30, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
7,530
Locations
1
Primary Endpoint
Acute Malnutrition

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
6 Months to 23 Months (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •All 6-23 months old children

Exclusion Criteria

  • •6-23 months old children with severe acute malnutrition.

Arms & Interventions

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.

Intervention: Bahgina (Dietary Supplement)

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.

Intervention: SQLNS (Dietary Supplement)

Control

No Intervention

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

Outcomes

Primary Outcomes

Acute Malnutrition

Time Frame: six months

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Afework Mulugeta

Professor

Mekelle University

Study Sites (1)

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