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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later across 2 updates Aug 31, 2026 → Jul 31, 2027
See other at-risk trials from Aga Khan University

Record History

  1. Primary completion moved earlier from Jun 30, 2028 to Jul 31, 2027 Enrollment target: 1508 to 1568 · Secondary endpoints: details revised at 4 of 4 entries · Site contacts updated at 2 of 2 sites · 1 morev5 Show 4 more changesShow less
    • Enrollment target: 1508 to 1568
    • Secondary endpoints: details revised at 4 of 4 entries
    • Site contacts updated at 2 of 2 sites
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion pushed from Aug 31, 2026 to Jun 30, 2028 Enrollment increased: 980 → 1508 participants · Completion pushed from Mar 31, 2027 to Dec 31, 2028 · Secondary endpoints: details revised at 4 of 4 entries · 2 morev4 Show 5 more changesShow less
    • Enrollment increased: 980 → 1508 participants
    • Completion pushed from Mar 31, 2027 to Dec 31, 2028
    • Secondary endpoints: details revised at 4 of 4 entries
    • Site details revised at 2 of 2 sites
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  3. Eligibility criteria expanded, about 4 wordsv3 See this version in full on ClinicalTrials.gov ↗
  4. Primary endpoint(s) modified Recruitment opened · Enrollment increased: 706 → 980 participants · Primary completion moved earlier from Feb 16, 2027 to Aug 31, 2026 · 6 morev2 Show 9 more changesShow less
    • Recruitment opened
    • Enrollment increased: 706 → 980 participants
    • Primary completion moved earlier from Feb 16, 2027 to Aug 31, 2026
    • Completion pushed from Feb 16, 2027 to Mar 31, 2027
    • Start date changed from estimate of Feb 16, 2026 to Feb 26, 2026
    • Secondary endpoints: 1 to 4
    • Site details revised at 2 of 2 sites
    • Eligibility criteria expanded, about 4 words
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 12 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 will be followed until 12 months of age. Participants will: * Receive either SQ-LNS or MQ-LNS once daily until 12 months of age * Have their length, weight and mid-upper arm circumference (MUAC) measured monthly * Have their blood screened for anemia at enrollment and at 12 months of age
Trial Details
NCT Number NCT07451951
Lead Sponsor Aga Khan University
Collaborators: United Nations World Food Programme (WFP), Benazir Income Support Programme (BISP)
Conditions Undernutrition
Enrollment 1,568 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov