ClinicalTrials.gg
RecruitingNCT07451951Updated Sep 3, 2026

Effectiveness of Small-Quantity vs Medium-Quantity Lipid-Based Nutrient Supplements for Prevention of Undernutrition in Young Children

An interventional study of Medium-quantity lipid-based nutrient supplement (MQ-LNS) and Small-quantity lipid-based nutrient supplement (SQ-LNS) in Undernutrition, sponsored by Aga Khan University. Recruiting at 2 sites in Pakistan. Open to participants aged 26 Weeks to 33 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by Aga Khan University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Feb 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,568
Allocation
Randomized
Ages
26 Weeks to 33 Weeks
Sex
All
01

Study summary

Nutrition is essential for a child's growth, brain development, and protection from disease. While breastmilk provides the best nutrition for young infants, children older than six months may not get all the nutrients they need from breastmilk and regular foods alone. For this reason, some children receive special nutrient supplements to support healthy growth.

Lipid-based nutrient supplements (LNS) are one type of supplement that provides important vitamins and minerals. These supplements are used in many countries to help prevent undernutrition in young children. In Pakistan, the government-led multisectoral nutrition program under the social safety net program currently provides medium-quantity LNS to children starting at six months of age. However, it is not known whether a smaller-quantity LNS could provide similar benefits for children in this age group from under-resourced communities that have limited access to nutritious foods.

The goal of this trial is to learn whether small-quantity lipid-based nutrient supplements (SQ-LNS) work as well as medium-quantity lipid-based nutrient supplements (MQ-LNS) in preventing undernutrition in children aged 6 to 12 months.

The main questions this study aims to answer are:

  • Does SQ-LNS work as well as MQ-LNS in supporting healthy growth, including reducing stunting, wasting, and underweight?
  • Does SQ-LNS work as well as MQ-LNS in reducing anemia?

Researchers will compare SQ-LNS and MQ-LNS to see if SQ-LNS is as good as MQ-LNS in preventing undernutrition.

The study is being conducted in Dadu and Peshawar, Pakistan. Participants will be followed until 12 months of age.

Participants will:

  • Receive either SQ-LNS or MQ-LNS once daily until 12 months of age
  • Have their length, weight and mid-upper arm circumference (MUAC) measured monthly
  • Have their blood screened for anemia at enrollment and at 12 months of age
02

Conditions studied

  • Undernutrition

Keywords

  • Stunting
  • Wasting
  • Anemia
  • Underweight
  • Small-quantity lipid-based nutrient supplement
  • Child nutrition
  • Medium-quantity lipid-based nutrient supplement
03

In context

Malnutrition

1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.

This study's planned enrollment of 1,568 is above the median of 118 across 843 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Aga Khan University is the lead sponsor of 294 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
26 Weeks to 33 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children aged 6 months (26 weeks) to 7 months and 15 days (33 weeks) with weight-for-length z-score (WLZ) ≥ -2 standard deviation (SD) and mid-upper arm circumference (MUAC) ≥125 mm, born to mothers who are beneficiaries of the Benazir Income Support Programme and registered with the Benazir Nashonuma Programme (BNP) at any point during their pregnancy.
  • Permanent residents of the selected districts, with no plan to relocate or migrate within the next 6 months.
  • Written provided by the child's caregivers.

Exclusion criteria

Exclusion Criteria:

  • Children with moderate acute malnutrition (MAM), defined as WLZ ≥ -3 to \< -2 SD, or MUAC ≥115 mm to \<125 mm.
  • Children with severe acute malnutrition (SAM), defined as WLZ \< -3 SD or MUAC \<115 mm or presence of bilateral pitting edema, who require therapeutic feeding.
  • Children with known congenital anomalies, chronic illness, or conditions affecting growth or feeding (for example, cerebral palsy or congenital heart disease).
  • Children already enrolled in any nutritional supplementation other than BNP or another clinical trial.
  • Children whose families will be unwilling to provide , or likely to be unavailable for follow-up.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,568 participants (estimated)

Study arms

  • Active comparator
    Medium-quantity lipid-based nutrient supplement (MQ-LNS)

    Children receiving MQ-LNS

    Dietary Supplement: Medium-quantity lipid-based nutrient supplement (MQ-LNS)

  • Experimental
    Small-quantity lipid-based nutrient supplement (SQ-LNS)

    Children receiving SQ-LNS

    Dietary Supplement: Small-quantity lipid-based nutrient supplement (SQ-LNS)

Interventions

  • Dietary supplementMedium-quantity lipid-based nutrient supplement (MQ-LNS)

    50 g/day lipid-based nutrient supplement providing energy and essential micronutrients, administered daily for 6 months.

  • Dietary supplementSmall-quantity lipid-based nutrient supplement (SQ-LNS)

    20 g/day lipid-based nutrient supplement providing energy and essential micronutrients, administered daily for 6 months.

06

What researchers measure

Primary outcomes

  1. Stunting

    length-for-age z-score (LAZ) \< -2 SD

    Time frame: Monthly from enrollment to the end of intervention period at 6 months

Secondary outcomes

  1. Wasting

    weight-for-length z-score (WLZ) \< -2 SD

    Time frame: Monthly from enrollment to the end of intervention period at 6 months

  2. Underweight

    weight-for-age z-score (WAZ) \< -2 SD

    Time frame: Monthly from enrollment to the end of intervention period at 6 months

  3. Morbidity

    Includes diarrhea (liquid stools defined as ≥3 loose or watery stools within 24 hour), respiratory infection (cough plus rapid, difficult breathing), vomiting, fever, rash/sores, coughing, wheezing and pneumonia.

    Time frame: Monthly from enrollment to the end of intervention period at 6 months

  4. Prevalence of anemia

    hemoglobin \<10.5 g/dL. For mild anemia: hemoglobin 9.5 - 10.4 g/dL For moderate anemia: 7.0 - 9.4 g/dL For severe anemia: \<7.0 g/dL

    Time frame: At enrollment and later at the end of intervention period at 6 months

07

Study locations

2 of 2 sites recruiting
  • BNP Facilitation Centers
    Peshawar, Khyber Pakhtunkhwa, Pakistan
    Recruiting
  • BNP Facilitation Centers
    Dadu, Sindh, Pakistan
    Recruiting
08

References and documents

Publications

  • Dewey KG, Arnold CD, Wessells KR, Stewart CP. Lipid-based nutrient supplements for prevention of child undernutrition: when less may be more. Am J Clin Nutr. 2023 Dec;118(6):1133-1144. doi: 10.1016/j.ajcnut.2023.09.007. Epub 2023 Sep 23. PubMed 37742931 ↗
  • Prado EL, Arnold CD, Wessells KR, Stewart CP, Abbeddou S, Adu-Afarwuah S, Arnold BF, Ashorn U, Ashorn P, Becquey E, Brown KH, Chandna J, Christian P, Dentz HN, Dulience SJL, Fernald LCH, Galasso E, Hallamaa L, Hess SY, Huybregts L, Iannotti LL, Jimenez EY, Kohl P, Lartey A, Le Port A, Luby SP, Maleta K, Matchado A, Matias SL, Mridha MK, Ntozini R, Null C, Ocansey ME, Parvez SM, Phuka J, Pickering AJ, Prendergast AJ, Shamim AA, Siddiqui Z, Tofail F, Weber AM, Wu LSF, Dewey KG. Small-quantity lipid-based nutrient supplements for children age 6-24 months: a systematic review and individual participant data meta-analysis of effects on developmental outcomes and effect modifiers. Am J Clin Nutr. 2021 Nov 2;114(Suppl 1):43S-67S. doi: 10.1093/ajcn/nqab277. PubMed 34590116 ↗
  • Dewey KG, Stewart CP, Wessells KR, Prado EL, Arnold CD. Small-quantity lipid-based nutrient supplements for the prevention of child malnutrition and promotion of healthy development: overview of individual participant data meta-analysis and programmatic implications. Am J Clin Nutr. 2021 Nov 2;114(Suppl 1):3S-14S. doi: 10.1093/ajcn/nqab279. PubMed 34590696 ↗
  • Stewart CP, Dewey KG, Lin A, Pickering AJ, Byrd KA, Jannat K, Ali S, Rao G, Dentz HN, Kiprotich M, Arnold CD, Arnold BF, Allen LH, Shahab-Ferdows S, Ercumen A, Grembi JA, Naser AM, Rahman M, Unicomb L, Colford JM Jr, Luby SP, Null C. Effects of lipid-based nutrient supplements and infant and young child feeding counseling with or without improved water, sanitation, and hygiene (WASH) on anemia and micronutrient status: results from 2 cluster-randomized trials in Kenya and Bangladesh. Am J Clin Nutr. 2019 Jan 1;109(1):148-164. doi: 10.1093/ajcn/nqy239. PubMed 30624600 ↗
  • Siega-Riz AM, Estrada Del Campo Y, Kinlaw A, Reinhart GA, Allen LH, Shahab-Ferdows S, Heck J, Suchindran CM, Bentley ME. Effect of supplementation with a lipid-based nutrient supplement on the micronutrient status of children aged 6-18 months living in the rural region of Intibuca, Honduras. Paediatr Perinat Epidemiol. 2014 May;28(3):245-54. doi: 10.1111/ppe.12117. Epub 2014 Mar 13. PubMed 24628577 ↗
  • Abbeddou S, Yakes Jimenez E, Some JW, Ouedraogo JB, Brown KH, Hess SY. Small-quantity lipid-based nutrient supplements containing different amounts of zinc along with diarrhea and malaria treatment increase iron and vitamin A status and reduce anemia prevalence, but do not affect zinc status in young Burkinabe children: a cluster-randomized trial. BMC Pediatr. 2017 Feb 2;17(1):46. doi: 10.1186/s12887-016-0765-9. PubMed 28152989 ↗
  • Das JK, Salam RA, Hadi YB, Sadiq Sheikh S, Bhutta AZ, Weise Prinzo Z, Bhutta ZA. Preventive lipid-based nutrient supplements given with complementary foods to infants and young children 6 to 23 months of age for health, nutrition, and developmental outcomes. Cochrane Database Syst Rev. 2019 May 2;5(5):CD012611. doi: 10.1002/14651858.CD012611.pub3. PubMed 31046132 ↗

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD) underlying the results reported in publications will be shared.

Supporting information: Study protocol, Analytic code

Time frame: January 2028 - January 2035

Access criteria: Access to de-identified IPD will be provided to researchers upon reasonable request. Data access will be subject to approval by the Principal Investigator and the ethical review committee of Aga Khan University. Data will be shared through a secure data transfer mechanism.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Jul 2027, 17 months after the start.

Of 392 non-industry interventional studies with no phase under Malnutrition, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's planned 17 months is below that.

Counting every sponsor, half of 418 studies reached it within 22 months; a quarter within 11 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 2, 2026
First posted
Mar 5, 2026
StartActual
Feb 26, 2026
Primary completionEst.
Jul 31, 2027
CompletionEst.
Dec 31, 2028
Last update
Sep 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07451951
Collaborators
United Nations World Food Programme (WFP), Benazir Income Support Programme (BISP)
Responsible party
Dr Shabina Ariff (Professor Shabina Ariff, Aga Khan University) — Principal investigator
First posted
Mar 5, 2026
Start date
Feb 26, 2026
Primary completion
Jul 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 3, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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