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UndernutritionNCT07451951

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

A study testing Medium-quantity lipid-based nutrient supplement (MQ-LNS) and Small-quantity lipid-based nutrient supplement (SQ-LNS) in people with Undernutrition, run by Aga Khan University at 2 sites in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 26 to 33 weeksHealthy volunteers can take part
Conditions the study is for
Undernutrition
What is being tested?
Medium-quantity lipid-based nutrient supplement (MQ-LNS) and Small-quantity lipid-based nutrient supplement (SQ-LNS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,568 participants
Where
2 sitesPakistan
Study dates
26 Feb 2026to 31 Dec 2028
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 26 to 33 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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 informed consent provided by the child's caregivers.

Who cannot join

  • 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 informed consent, or likely to be unavailable for follow-up.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Pakistan2 sites, 2 recruiting
  • BNP Facilitation Centers

    Dadu, Sindh

    Dr Sajid Soofi, +922134864798, sajid.soofi@aku.edu

    Recruiting
  • BNP Facilitation Centers

    Peshawar, Khyber Pakhtunkhwa

    Dr Sajid Soofi, +922134864798, sajid.soofi@aku.edu

    Recruiting

Other trials in Pakistan

About this study

Official title: Effectiveness of Small-Quantity vs Medium-Quantity Lipid-Based Nutrient Supplements for Prevention of Undernutrition in Young Children: An Individually Randomized, Parallel-Group, Non-Inferiority Trial

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.

Read more

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
Conditions
Undernutrition
Being tested
Medium-quantity lipid-based nutrient supplement (MQ-LNS), Small-quantity lipid-based nutrient supplement (SQ-LNS)
Keywords
Stunting, Wasting, Anemia, Underweight, Small-quantity lipid-based nutrient supplement, Child nutrition, Medium-quantity lipid-based nutrient supplement
Medical subject headings
Malnutrition, Growth Disorders, Cachexia, Anemia, Thinness

What participants receive

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

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

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

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

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

Study groups in NCT07451951
Study groupRoleWhat they receive
Medium-quantity lipid-based nutrient supplement (MQ-LNS)Active comparatorChildren receiving MQ-LNS
Receives: Dietary Supplement: Medium-quantity lipid-based nutrient supplement (MQ-LNS)
Small-quantity lipid-based nutrient supplement (SQ-LNS)ExperimentalChildren receiving SQ-LNS
Receives: Dietary Supplement: Small-quantity lipid-based nutrient supplement (SQ-LNS)

What is being measured

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

  1. Stunting

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

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

Secondary outcomes (4)
  1. Wasting

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

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

  2. Underweight

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

    Measured: 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.

    Measured: 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

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

Timeline

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

  1. First posted5 Mar 2026
  2. Study start26 Feb 2026
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Dec 2028 (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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,568 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07451951
Sponsor's protocol ID
11806
Other IDs
1000001355
Status last verified
Sep 2026
First submitted
2 Mar 2026
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) underlying the results reported in publications will be shared.

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
  • Ariff S, Alam R, Chauhdary IA, Muhammad S, Khan GN, Maznani I, Wali N, Muhammad S, Ghaffar A, Ihtesham Y, Badar A, Raza A, Ijaz A, Rana R, de Pee S, Soofi S, Bhutta ZA. Effectiveness of small-quantity versus medium-quantity lipid-based nutrient supplements for prevention of undernutrition in young children: protocol for an individually randomised, parallel-group, non-inferiority trial. BMJ Open. 2026 Sep 29;16(9):e122865. doi: 10.1136/bmjopen-2026-122865.

    PubMed 42810807

Questions about this trial

What is this clinical trial studying?

A study testing Medium-quantity lipid-based nutrient supplement (MQ-LNS) and Small-quantity lipid-based nutrient supplement (SQ-LNS) in people with Undernutrition, run by Aga Khan University at 2 sites in Pakistan.

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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Pakistan. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stunting (time frame: Monthly from enrollment to the end of intervention period at 6 months). 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 NCT07451951, which also lists 8 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 3 Sep 2026.

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