Comparing small and medium lipid-based nutrient supplements to prevent undernutrition in babies aged 6 to 12 months
Effectiveness of Small-Quantity vs Medium-Quantity Lipid-Based Nutrient Supplements for Prevention of Undernutrition in Children Aged 6-12 Months: An Individually Randomized, Parallel-Group, Non-Inferiority Trial
NA · Aga Khan University · NCT07451951
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 980 (estimated) |
| Ages | 6 Months to 7 Months |
| Sex | All |
| Sponsor | Aga Khan University (other) |
| Locations | 2 sites (Peshawar, Khyber Pakhtunkhwa and 1 other locations) |
| Trial ID | NCT07451951 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged 6 months to 6 months and 29 days 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 this trial is running
Peshawar, Khyber Pakhtunkhwa and 1 other locations
- BNP Facilitation Centers — Peshawar, Khyber Pakhtunkhwa, Pakistan (NOT_YET_RECRUITING)
- BNP Facilitation Centers — Dadu, Sindh, Pakistan (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Undernutrition, Stunting, Wasting, Anemia, Underweight, Small-quantity lipid-based nutrient supplement, Child nutrition, Medium-quantity lipid-based nutrient supplement