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PreventionNCT07540793

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

A study testing 7dp SQ-LNS and 1dp SQ-LNS in people with Prevention and Malnutrition, Child, run by University of California, San Francisco at 3 sites in 3 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 6 months and older
Conditions the study is for
Prevention, Malnutrition, Child, Nutrition
What is being tested?
7dp SQ-LNS and 1dp SQ-LNS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesin 3 countries
Study dates
May 2026to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Catherine Oldenburg, ScD contact

4154761442

catherine.oldenburg@ucsf.edu

Hadley Burroughs contact

hadley.burroughs@ucsf.edu

3 sites in 3 countries

Ethiopia1 site
  • Debre Berhan University

    Debre Berhan

    Awraris Hailu Bilchut, +251911373880, awrarishailu@gmail.com

Other trials in Ethiopia

Germany1 site
  • Heidelberg University

    Heidelberg

Other trials in Germany

Philippines1 site
  • Research Institute of Tropical Medicine

    Manila

Other trials in Philippines

About this study

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).

Read more

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.

Being tested
7dp SQ-LNS, 1dp SQ-LNS
Keywords
Small Quantity Lipid-based Nutrient Supplement, Child nutrition, Malnutrition prevention
Medical subject headings
Child Nutrition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 7dp SQ-LNSDietary supplement

    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).

  • 1dp SQ-LNSDietary supplement

    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).

Study groups in NCT07540793
Study groupRoleWhat they receive
1dp SQ-LNSActive comparatorRandomization 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).
Receives: Dietary Supplement: 1dp SQ-LNS
7dp SQ-LNSExperimentalRandomization 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).
Receives: Dietary Supplement: 7dp SQ-LNS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence

    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.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2026
  2. Study startMay 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07540793
Sponsor's protocol ID
25-44863
Status last verified
May 2026
First submitted
14 Apr 2026
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Seitz CM, Orsini MM. Thirty Years of Implementing the Photovoice Method: Insights From a Review of Reviews. Health Promot Pract. 2022 Mar;23(2):281-288. doi: 10.1177/15248399211053878.

    PubMed 35285331
  • Malterud K, Siersma VD, Guassora AD. Sample Size in Qualitative Interview Studies: Guided by Information Power. Qual Health Res. 2016 Nov;26(13):1753-1760. doi: 10.1177/1049732315617444. Epub 2016 Jul 10.

    PubMed 26613970
  • Kodish SR, Aburto NJ, Nseluke Hambayi M, Dibari F, Gittelsohn J. Patterns and determinants of small-quantity LNS utilization in rural Malawi and Mozambique: considerations for interventions with specialized nutritious foods. Matern Child Nutr. 2017 Jan;13(1):10.1111/mcn.12234. doi: 10.1111/mcn.12234. Epub 2016 Jan 19.

    PubMed 26787342
  • Stewart CP, Wessells KR, Arnold CD, Huybregts L, Ashorn P, Becquey E, Humphrey JH, Dewey KG. Lipid-based nutrient supplements and all-cause mortality in children 6-24 months of age: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2020 Jan 1;111(1):207-218. doi: 10.1093/ajcn/nqz262.

    PubMed 31697329
  • Hess SY, Abbeddou S, Jimenez EY, Some JW, Vosti SA, Ouedraogo ZP, Guissou RM, Ouedraogo JB, Brown KH. Small-quantity lipid-based nutrient supplements, regardless of their zinc content, increase growth and reduce the prevalence of stunting and wasting in young burkinabe children: a cluster-randomized trial. PLoS One. 2015 Mar 27;10(3):e0122242. doi: 10.1371/journal.pone.0122242. eCollection 2015.

    PubMed 25816354
  • Dewey KG, Arnold CD, Wessells KR, Prado EL, Abbeddou S, Adu-Afarwuah S, Ali H, Arnold BF, Ashorn P, Ashorn U, Ashraf S, Becquey E, Brown KH, Christian P, Colford JM Jr, Dulience SJ, Fernald LC, Galasso E, Hallamaa L, Hess SY, Humphrey JH, Huybregts L, Iannotti LL, Jannat K, Lartey A, Le Port A, Leroy JL, Luby SP, Maleta K, Matias SL, Mbuya MN, Mridha MK, Nkhoma M, Null C, Paul RR, Okronipa H, Ouedraogo JB, Pickering AJ, Prendergast AJ, Ruel M, Shaikh S, Weber AM, Wolff P, Zongrone A, Stewart CP. Preventive small-quantity lipid-based nutrient supplements reduce severe wasting and severe stunting among young children: an individual participant data meta-analysis of randomized controlled trials. Am J Clin Nutr. 2022 Nov;116(5):1314-1333. doi: 10.1093/ajcn/nqac232. Epub 2023 Feb 10.

    PubMed 36045000
  • Aguayo VM, Baker SK, Dewey KG, Galasso E, Perry A, Sifri Z, Aburmishan D, de Pee S, Guerrero Oteyza SI, Moloney G, Prado EL, Rawat R, Shaker-Berbari L, Shekar M, Stewart CP, Tumilowicz A, Wessells KR. Benefits of small-quantity lipid-based nutrient supplements for child nutrition and survival warrant moving to scale. Nat Food. 2023 Feb;4(2):130-132. doi: 10.1038/s43016-023-00703-2. No abstract available.

    PubMed 37117857
  • Abbeddou S, Hess SY, Yakes Jimenez E, Some JW, Vosti SA, Guissou RM, Ouedraogo JB, Brown KH. Comparison of methods to assess adherence to small-quantity lipid-based nutrient supplements (SQ-LNS) and dispersible tablets among young Burkinabe children participating in a community-based intervention trial. Matern Child Nutr. 2015 Dec;11 Suppl 4(Suppl 4):90-104. doi: 10.1111/mcn.12162.

    PubMed 25521188
  • Louis TA, Lavori PW, Bailar JC 3rd, Polansky M. Crossover and self-controlled designs in clinical research. N Engl J Med. 1984 Jan 5;310(1):24-31. doi: 10.1056/NEJM198401053100106.

    PubMed 6689736
  • Oldenburg CE, Ouattara M, Bountogo M, Boudo V, Ouedraogo T, Compaore G, Dah C, Zakane A, Coulibaly B, Bagagnan C, Hu H, O'Brien KS, Nyatigo F, Keenan JD, Doan T, Porco TC, Arnold BF, Lebas E, Sie A, Lietman TM. Mass Azithromycin Distribution to Prevent Child Mortality in Burkina Faso: The CHAT Randomized Clinical Trial. JAMA. 2024 Feb 13;331(6):482-490. doi: 10.1001/jama.2023.27393.

    PubMed 38349371

Questions about this trial

What is this clinical trial studying?

A study testing 7dp SQ-LNS and 1dp SQ-LNS in people with Prevention and Malnutrition, Child, run by University of California, San Francisco at 3 sites in 3 countries.

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 8 inclusion and 7 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: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Ethiopia, Germany, Philippines. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Catherine Oldenburg, ScD (4154761442, catherine.oldenburg@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07540793, which also lists 10 linked publications.

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 14 May 2026.

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