Academic Journal
Effectiveness of small-quantity versus medium-quantity lipid-based nutrient supplements for prevention of undernutrition in young children: protocol for an individually randomised, parallel-group, non-inferiority trial.
| Title: | Effectiveness of small-quantity versus medium-quantity lipid-based nutrient supplements for prevention of undernutrition in young children: protocol for an individually randomised, parallel-group, non-inferiority trial. |
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| Authors: | Ariff S; Department of Paediatrics and Child Health, The Aga Khan University, Karachi, Sindh, Pakistan., Alam R; Centre of Excellence in Women and Child Health, The Aga Khan University, Karachi, Sindh, Pakistan., Chauhdary IA; Paediatircs, Aga Khan University, Karachi, Pakistan., Muhammad S; Centre of Excellence in Women & Child Health, Aga Khan University, Karachi, Pakistan., Khan GN; Centre of Excellence in Women and Child Health, The Aga Khan University, Karachi, Sindh, Pakistan., Maznani I; Centre of Excellence in Women & Child Health, Aga Khan University, Karachi, Pakistan., Wali N; Centre of Excellence in Women and Child Health, The Aga Khan University, Karachi, Sindh, Pakistan., Muhammad S; Centre of Excellence in Women and Child Health, The Aga Khan University, Karachi, Sindh, Pakistan., Ghaffar A; Center of Excellence in Women and Child Health, The Aga Khan University, Karachi, Pakistan., Ihtesham Y; World Food Programme, Islamabad, Pakistan., Badar A; World Food Programme, Islamabad, Pakistan., Raza A; Benazir Income Support Programme, Islamabad, Pakistan., Ijaz A; Benazir Income Support Programme, Islamabad, Pakistan., Rana R; World Food Programme, Rome, Lazio, Italy., de Pee S; World Food Programme, Rome, Lazio, Italy., Soofi S; Department of Paediatrics and Child Health, The Aga Khan University, Karachi, Sindh, Pakistan sajid.soofi@aku.edu.; Centre of Excellence in Women and Child Health, The Aga Khan University, Karachi, Sindh, Pakistan., Bhutta ZA; Division of Women and Child Health, The Aga Khan University, Karachi, Pakistan.; Global Child Health, Hospital for Sick Children Research Institute, Toronto, Ontario, Canada. |
| Source: | BMJ open [BMJ Open] 2026 Sep 29; Vol. 16 (9), pp. e122865. Date of Electronic Publication: 2026 Sep 29. |
| Publication Type: | Journal Article; Clinical Trial Protocol |
| Language: | English |
| Journal Info: | Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [London] : BMJ Publishing Group Ltd, 2011- |
| MeSH Terms: | Malnutrition*/prevention & control , Lipids*/administration & dosage , Infant Nutrition Disorders*/prevention & control , Dietary Supplements*, Growth Disorders/prevention & control ; Humans ; Infant ; Pakistan ; Equivalence Trials as Topic ; Randomized Controlled Trials as Topic ; Female |
| Abstract: | Introduction: Undernutrition during the first 2 years of life remains a major public health challenge in Pakistan. Lipid-based nutrient supplements (LNS) are widely used to prevent growth faltering in nutritionally at-risk populations. Evidence shows that small-quantity LNS (SQ-LNS, 20 g/day) is effective in preventing undernutrition; however, evidence comparing SQ-LNS with medium-quantity LNS (MQ-LNS, 50 g/day) under programmatic conditions (especially in food-insecure poor households) remains limited. Given that the MQ-LNS daily dose may be too large for older infants to consume fully, comparative effectiveness evidence is needed to inform the national stunting prevention programme. This study compares the effectiveness of SQ-LNS versus MQ-LNS in reducing undernutrition (stunting, wasting and underweight) and anaemia among children aged 6-12 months enrolled in the Benazir Nashonuma Programme (BNP), a government-led nutrition-sensitive social protection programme. Methods and Analysis: This will be an individually randomised, parallel-group, non-inferiority trial conducted within BNP facilitation centres in Dadu and Peshawar districts. Eligible children aged 6-7.5 months will be randomised 1:1 to receive either 20 g/day SQ-LNS or 50 g/day MQ-LNS for 6 months. The primary outcome is stunting assessed using the WHO's Child Growth Standards. Secondary outcomes are wasting, underweight, anthropometric z-scores, morbidity and anaemia. The required sample size is estimated at 1060 (530 per arm) for Dadu and 508 (254 per arm) for Peshawar. Analyses will follow a non-inferiority framework using a mixed-effects logistic regression model adjusted for relevant covariates. Additionally, we will assess utilisation and acceptability of the intervention among beneficiaries. Ethics and Dissemination: Ethical approval has been obtained from the Aga Khan University Ethical Review Committee (2025-11806-38699) and the National Bioethics Committee of Pakistan (NBCR-1380). We will obtain written informed consent from mothers of eligible children. Findings will be disseminated through engagement with government stakeholders and implementing partners, as well as through peer-reviewed publications and scientific forums. Trial Registration Number: NCT07451951. (© Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.) |
| Competing Interests: | Competing interests: None declared. |
| Contributed Indexing: | Keywords: Child; NUTRITION & DIETETICS; PUBLIC HEALTH; Pakistan; Randomized Controlled Trial |
| Molecular Sequence: | ClinicalTrials.gov NCT07451951 |
| Substance Nomenclature: | 0 (Lipids) |
| Entry Date(s): | Date Created: 20260929 Date Completed: 20260929 Latest Revision: 20260930 |
| Update Code: | 20261001 |
| DOI: | 10.1136/bmjopen-2026-122865 |
| PMID: | 42810807 |
| Database: | MEDLINE |
| ISSN: | 2044-6055 |
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| DOI: | 10.1136/bmjopen-2026-122865 |