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Not Yet RecruitingNCT07451951

Effectiveness of SQLNS vs MQLNS for Prevention of Undernutrition in Children 6-12 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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
706 (estimated)
Sponsor
Aga Khan University · Academic / Other
Sex
All
Age
6 Months – 7 Months
Healthy volunteers
Accepted

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 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 six to twelve 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. Participants will: * Receive either SQ-LNS or MQ-LNS once daily for 6 months * Have their length, weight and mid-upper arm circumference (MUAC) measured monthly * Have their blood tested for anemia at the start and end of supplementation

Conditions

Interventions

TypeNameDescription
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.

Timeline

Start date
2026-02-16
Primary completion
2027-02-16
Completion
2027-02-16
First posted
2026-03-05
Last updated
2026-03-05

Locations

2 sites across 1 country: Pakistan

Source: ClinicalTrials.gov record NCT07451951. Inclusion in this directory is not an endorsement.