Comparing small and medium lipid-based nutrient supplements to prevent undernutrition in babies aged 6 to 12 months
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
Run by Aga Khan University · NCT07451951 · Data updated 2026-11-12
This project will try giving small versus medium doses of lipid-based nutrient supplements to babies aged 6 to 12 months to see which dose better prevents undernutrition.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 26 Weeks to 33 Weeks |
| Sex | All |
| Enrollment | 1568 (estimated) |
| Sponsor | Aga Khan University Academic / other |
| Locations | 2 sites (Peshawar, Khyber Pakhtunkhwa and 1 other locations) |
| Status | Recruiting |
| Started | February 26, 2026 |
| Main results expected | July 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | September 3, 2026 |
| Trial ID | NCT07451951 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are infants aged 6 months who are registered beneficiaries of the Benazir Income Support Programme, are permanent residents of the selected districts, and meet the trial's nutritional and health criteria.
✕Probably not a fit
Children with moderate or severe acute malnutrition, significant chronic illnesses or congenital conditions affecting growth or feeding, or those planning to relocate are unlikely to benefit from this preventive supplementation approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Infants who are 6 months old and enrolled in the Benazir Nashonuma programme are recruited at selected BNP facilitation centers. Enrolled children receive either a small-quantity or a medium-quantity lipid-based nutrient supplement and are followed through early infancy to measure growth and nutrition outcomes. Outcomes include measures of stunting, wasting, underweight, and anemia. The supplements are delivered through existing government program channels and outcomes in the two groups are compared to determine relative effectiveness.
Why it matters
Potential benefit: If a smaller-quantity supplement works as well as a medium-quantity one, programs could reach more children at lower cost and simplify delivery while protecting growth and health.
How similar studies have gone: Lipid-based nutrient supplements have shown benefits for child growth and nutrition in multiple countries, though direct head-to-head comparisons of small versus medium quantities are less frequently reported.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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BNP Facilitation Centers
Peshawar, Khyber Pakhtunkhwa, Pakistan Recruiting -
BNP Facilitation Centers
Dadu, Sindh, Pakistan Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.