Acute Malnutrition in ChildhoodELOFSAMNCT06103084
Effectiveness of Local Food Solutions for the Prevention of Acute Malnutrition in Tigray, Northern Ethiopia (ELOFSAM)
A study testing Bahgina and SQLNS in people with Acute Malnutrition in Childhood, run by Mekelle University at 1 site in Ethiopia.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Acute Malnutrition in Childhood
- What is being tested?
- Bahgina and SQLNS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,530 participants
- Where
- 1 siteEthiopia
- Study dates
- 30 Jun 2023to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All 6-23 months old children
Who cannot join
- 6-23 months old children with severe acute malnutrition.
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site, 1 recruiting
- Recruiting
Tigray Health Research Institute
Mek'ele, Tigray, 1547
Hayelom Kahsay, MD, +251937404971, hayelomk21@gmail.com
Afework Mulugeta, PhD
About this study
Official title: Acceptability and Effectiveness of Local Food Solutions for the Prevention of Acute Malnutrition in Tigray, Northern Ethiopia (ELOFSAM)
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
- Being tested
- Bahgina, SQLNS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BahginaDietary 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.
SQLNSDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Malnutrition
The burden or prevalence of acute malnutrition among 6-23 months old children.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start30 Jun 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Malnutrition in ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mekelle University
- Sponsor type
- University, hospital or other
- Collaborators
- Tigray Development Association, Mums for Mums, Tigray Health Research Institute, Tigray Health Bureau, UNICEF Tigray Office
- Responsible party
- Principal investigator, Afework Mulugeta, Mekelle University
- Investigators
- Hayelom Kahsay, MD, Study chair, Tigray Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103084
- Sponsor's protocol ID
- MUCHS
- Acronym
- ELOFSAM
- Status last verified
- Oct 2023
- First submitted
- 22 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Effectiveness of Local Food Solutions for the Prevention of Acute Malnutrition in Tigray, Northern Ethiopia (ELOFSAM)
- ClinicalTrials.gov ID
- NCT06103084
- Acronym / sponsor ID
- ELOFSAM / MUCHS
- Conditions
- Acute Malnutrition in Childhood
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7,530 participants (estimated)
- Lead sponsor
- Mekelle UniversityUniversity, hospital or other
- Collaborators
- Tigray Development Association, Mums for Mums, Tigray Health Research Institute, Tigray Health Bureau, UNICEF Tigray Office
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bahgina group | Experimental | Dietary Supplement: BahginaThe Bahgina treatment group will be supplemented with Bahgina, a locally produced cereal based product for a maximum of six months at 200g/day. |
| SQLNS group | Experimental | Dietary Supplement: SQLNSThe small quantity lipid based nutrient supplements (SQLNS) group will be provided with 20g of SQLNS/day for a maximum of six months. |
| Control | No intervention | –The control group will get nothing except the routine nutrition services and products provided by the local government sectors. |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All 6-23 months old children
Key exclusion criteria (1 listed)
- 6-23 months old children with severe acute malnutrition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BahginaBahgina, 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. | Dietary supplement | Bahgina group |
| SQLNSSmall 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. | Dietary supplement | SQLNS group |
Primary outcome
Acute Malnutrition
Time frame: six months
The burden or prevalence of acute malnutrition among 6-23 months old children.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hayelom Kahsay, MD study chair
Tigray Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bahgina and SQLNS in people with Acute Malnutrition in Childhood, run by Mekelle University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Afework Mulugeta, PhD (+251 914 382045, afework.mulugeta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Malnutrition (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.