RecruitingNot Applicable

Effectiveness of Small-Quantity vs Medium-Quantity Lipid-Based Nutrient Supplements for Prevention of Undernutrition in Children 6-24 Months

Pakistan1,508 participantsStarted 2026-02-26

Plain-language 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 24 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 in Dadu will be followed until 24 months of age, while participants in Peshawar will be followed until 12 months of age. Participants will: * Receive either SQ-LNS or MQ-LNS once daily until 24 months of age (Dadu) or 12 months of age (Peshawar) * Have their length, weight and mid-upper arm circumference (MUAC) measured monthly * Have their blood screened for anemia at enrollment and at 12 and 24 months of age (Dadu) or at enrollment and 12 months of age (Peshawar)

Who can participate

Age range

26 Weeks – 33 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 informed consent provided by the child's caregivers. 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 informed consent, or likely to be unavailable for follow-up.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Stunting

Timeframe: Dadu: monthly from enrollment to 24 months of participant's age Peshawar: monthly from enrollment to 12 months of participant's age

Trial details

NCT IDNCT07451951

SponsorAga Khan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-30

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