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

Sponsor

Mekelle University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06103084

Collaborator

Tigray Development Association (Other), Mums for Mums (Other), Tigray Health Research Institute (Other), Tigray Health Bureau (Other), UNICEF Tigray Office (Other)

7,530

Enrollment

Location

Arms

Anticipated Duration (Months)

943.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Malnutrition in Childhood	Dietary Supplement: Bahgina Dietary Supplement: SQLNS	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

7530 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 30, 2023

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bahgina group 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 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.
Experimental: SQLNS group 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 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.
No Intervention: Control The control group will get nothing except the routine nutrition services and products provided by the local government sectors.

Arm

Intervention/Treatment

Experimental: Bahgina group

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

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.

Experimental: SQLNS group

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

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.

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

Acute Malnutrition [six months]
The burden or prevalence of acute malnutrition among 6-23 months old children.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 23 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

All 6-23 months old children

Exclusion Criteria:

6-23 months old children with severe acute malnutrition.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tigray Health Research Institute	Mek'ele	Tigray	Ethiopia	1547

Sponsors and Collaborators

Mekelle University
Tigray Development Association
Mums for Mums
Tigray Health Research Institute
Tigray Health Bureau
UNICEF Tigray Office

Investigators

Study Chair: Hayelom Kahsay, MD, Tigray Health Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Afework Mulugeta, Professor, Mekelle University

ClinicalTrials.gov Identifier:

NCT06103084

Other Study ID Numbers:

MUCHS

First Posted:

Oct 26, 2023

Last Update Posted:

Oct 26, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Malnutrition

Study Results

No Results Posted as of Oct 26, 2023