Evaluation of 7-day vs 1-day Packaging of Small Quantity Lipid-based Nutrition Supplementation (SQ-LNS)

May 11, 2026 updated by: University of California, San Francisco

Small Quantity Lipid-based Nutrient Supplements (SQ-LNS), are fortified, lipid-based nutritional supplements that were specifically designed for children 6-24 months to prevent malnutrition. Recent research has shown reductions in mortality, severe wasting, severe stunting, iron deficiency anemia, and developmental delays.

SQ-LNS is currently available in individual daily dose packets of 20g. Healthy children age 6-24 months receive 1 packet per day (1dp), and are typically given a 1- or 2- month supply at a time (30-60 packets).

Recently, Nutriset Développement has developed a new packaging design for SQ-LNS that reduces the cost by over 15% overall, through production efficiency with 40% less packaging, and improved transportation efficiency by 20%. This new packaging is a 140g packet that will allow 20g to be dispensed daily for 7 days (7dp). The packaging has a chamber that will allow for accurate 10g dosing (either twice daily, or twice at once). Users of the packaging will also be able to close the spout to minimize risk of microbiological contamination.

Edesia Nutrition is working with Nutriset to conduct field testing of this new packaging for SQ-LNS, and this mixed-methods study in North Shoa Zone, Amhara Region, Ethiopia, will help inform recommendations for the future use of the package. The study seeks to determine (1) the acceptability of integrating SQ-LNS distribution into the malnutrition program; (2) whether adherence to the 2 different package types differs, and if there are differences in usage; (3) and how the packages perform over time, their perceived safety and functionality, and how they are stored.

Educational and communication tools will be developed and pre-tested as part of this study, and will become part of the final deliverable package to Edesia Nutrition, in addition to final recommendations on the product packaging, findings about how the packages are used, and behavior change and nutrition education strategies.

The primary outcome of the quantitative evaluation will be adherence, calculated as the number of delivered doses of SQ-LNS divided by the number of expected doses per week (7).

Adherence will be measured via weekly self-report via caregiver interview and counts of return of used and unused packages during weekly home visits. The percentage of children who receive a dose during structured observation periods will be calculated. Each adherence outcome will be analyzed separately.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Ethiopia
      • Debre Berhan, Ethiopia
        • Debre Berhan University
        • Contact:
  • Germany
      • Heidelberg, Germany
        • Heidelberg University
  • Philippines
      • Manila, Philippines
        • Research Institute of Tropical Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria (must meet all):

  • Written informed consent from head of household
  • Household within the study area
  • Available for the full 8-week study period
  • 1 child aged 6-22 months in the household at time of enrollment
  • Child has MUAC ≥ 12.5cm
  • Child does not have any clinical complications requiring inpatient treatment or referral to the health post, according to Ethiopian malnutrition treatment guidelines**
  • Child is not allergic to peanuts, milk, or soy
  • Household does not have multiple children within the eligible age range

Exclusion Criteria (any excludes):

  • Head of household declines to sign written informed consent
  • Household is outside of the study area
  • Not available for the full 8-week study period
  • House has either multiple children aged 6-22 months in the household at time of enrollment, or 0 children aged 6-22 months at time of enrollment
  • Child has MUAC < 12.5cm
  • Child has any clinical complications requiring inpatient treatment or referral to the health post, according to Ethiopian malnutrition treatment guidelines
  • Child is allergic to peanuts, milk, or soy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1dp SQ-LNS

Randomization will occur after the baseline assessment. UCSF investigators will generate the randomization sequence. Households will be randomized in a 1:1 fashion to either a 1-month supply of 7DP or 1DP and then crossed over to the other packaging after one month.

Households will receive 2 months of SQ-LNS in total. 7DP will be provided as 4 packages per eligible child (28 days' worth of product) and 1DP will be provided as 28 packages per eligible child (28 days' worth of product).
Dietary supplement: 1dp SQ-LNS
Small Quantity Lipid-based Nutrient Supplements (SQ-LNS) are currently available in individual daily dose packets of 20g. Healthy children age 6-24 months receive 1 packet per day (1dp), and are typically given a 1- or 2- month supply at a time (30-60 packets).
Experimental: 7dp SQ-LNS

Randomization will occur after the baseline assessment. UCSF investigators will generate the randomization sequence. Households will be randomized in a 1:1 fashion to either a 1-month supply of 7DP or 1DP and then crossed over to the other packaging after one month.

Households will receive 2 months of SQ-LNS in total. 7DP will be provided as 4 packages per eligible child (28 days' worth of product) and 1DP will be provided as 28 packages per eligible child (28 days' worth of product).
Dietary supplement: 7dp SQ-LNS

Small Quantity Lipid-based Nutrient Supplements (SQ-LNS) are currently available in individual daily dose packets of 20g. Healthy children age 6-24 months receive 1 packet per day (1dp), and are typically given a 1- or 2- month supply at a time (30-60 packets).

The 7-day package of SQ-LNS has been developed by Nutriset Développement to improve costs and production and transportation efficiency. The new packaging allows 20g to be dispensed daily for 7 days (7dp).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: 8 weeks
Adherence will be calculated as the number of delivered doses of SQ-LNS divided by the number of expected doses per week (7). Adherence will be measured via (1) weekly self-report via caregiver interview and (2) weighing (7dp) and counting (1dp) of used and unused sachets during weekly home visits.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Heidelberg University
Debre Berhan University
Research Institute for Tropical Medicine, Philippines

Investigators

  • Principal Investigator: Catherine Oldenburg, ScD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-44863

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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