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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: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 7 months
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Pakistan
BNP Facilitation Centers
RECRUITING
Dadu
BNP Facilitation Centers
NOT_YET_RECRUITING
Peshawar
Time Frame
Start Date: 2026-02-26
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 980
Treatments
Active_comparator: Medium-quantity lipid-based nutrient supplement (MQ-LNS)
Children receiving MQ-LNS
Active_comparator: Small-quantity lipid-based nutrient supplement (SQ-LNS)
Children receiving SQ-LNS
Related Therapeutic Areas
Sponsors
Leads: Aga Khan University
Collaborators: United Nations World Food Programme (WFP), Benazir Income Support Programme (BISP)

This content was sourced from clinicaltrials.gov

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