Effectiveness of Small-Quantity vs Medium-Quantity Lipid-Based Nutrient Supplements for Prevention of Undernutrition in Children 6-12 Months

Официальное название

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

Обзор

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

Вмешательства

• Пищевая добавка Medium-quantity lipid-based nutrient supplement (MQ-LNS)
  50 g/day lipid-based nutrient supplement providing energy and essential micronutrients, administered daily for 6 months.
• Пищевая добавка Small-quantity lipid-based nutrient supplement (SQ-LNS)
  20 g/day lipid-based nutrient supplement providing energy and essential micronutrients, administered daily for 6 months.

Первичные конечные точки

• Stunting [Срок оценки: From enrollment to the end of intervention period at 6 months]

Вторичные конечные точки (4)

• Wasting [Срок оценки: From enrollment to the end of intervention period at 6 months]
• Underweight [Срок оценки: From enrollment to the end of intervention period at 6 months]
• Morbidity [Срок оценки: From enrollment to the end of intervention period at 6 months]
• Prevalence of anemia [Срок оценки: At enrollment and later at the end of intervention period at 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Пакистан · 2 центра

• BNP Facilitation Centers — Peshawar
• BNP Facilitation Centers — Dadu

Публикации

• Dewey KG, Arnold CD, Wessells KR, Stewart CP. Lipid-based nutrient supplements for prevention of child undernutrition: when less may be more. Am J Clin Nutr. 2023 Dec;118(6):1133-1144. doi: 10.1016/j.ajcnut.2023.09.007. Epub 2023 Sep 23. PMID 37742931
• Prado EL, Arnold CD, Wessells KR, Stewart CP, Abbeddou S, Adu-Afarwuah S, Arnold BF, Ashorn U, Ashorn P, Becquey E, Brown KH, Chandna J, Christian P, Dentz HN, Dulience SJL, Fernald LCH, Galasso E, Hallamaa L, Hess SY, Huybregts L, Iannotti LL, Jimenez EY, Kohl P, Lartey A, Le Port A, Luby SP, Maleta K, Matchado A, Matias SL, Mridha MK, Ntozini R, Null C, Ocansey ME, Parvez SM, Phuka J, Pickering PMID 34590116
• Dewey KG, Stewart CP, Wessells KR, Prado EL, Arnold CD. Small-quantity lipid-based nutrient supplements for the prevention of child malnutrition and promotion of healthy development: overview of individual participant data meta-analysis and programmatic implications. Am J Clin Nutr. 2021 Nov 2;114(Suppl 1):3S-14S. doi: 10.1093/ajcn/nqab279. PMID 34590696
• Stewart CP, Dewey KG, Lin A, Pickering AJ, Byrd KA, Jannat K, Ali S, Rao G, Dentz HN, Kiprotich M, Arnold CD, Arnold BF, Allen LH, Shahab-Ferdows S, Ercumen A, Grembi JA, Naser AM, Rahman M, Unicomb L, Colford JM Jr, Luby SP, Null C. Effects of lipid-based nutrient supplements and infant and young child feeding counseling with or without improved water, sanitation, and hygiene (WASH) on anemia and PMID 30624600
• Siega-Riz AM, Estrada Del Campo Y, Kinlaw A, Reinhart GA, Allen LH, Shahab-Ferdows S, Heck J, Suchindran CM, Bentley ME. Effect of supplementation with a lipid-based nutrient supplement on the micronutrient status of children aged 6-18 months living in the rural region of Intibuca, Honduras. Paediatr Perinat Epidemiol. 2014 May;28(3):245-54. doi: 10.1111/ppe.12117. Epub 2014 Mar 13. PMID 24628577
• Abbeddou S, Yakes Jimenez E, Some JW, Ouedraogo JB, Brown KH, Hess SY. Small-quantity lipid-based nutrient supplements containing different amounts of zinc along with diarrhea and malaria treatment increase iron and vitamin A status and reduce anemia prevalence, but do not affect zinc status in young Burkinabe children: a cluster-randomized trial. BMC Pediatr. 2017 Feb 2;17(1):46. doi: 10.1186/s12 PMID 28152989
• Das JK, Salam RA, Hadi YB, Sadiq Sheikh S, Bhutta AZ, Weise Prinzo Z, Bhutta ZA. Preventive lipid-based nutrient supplements given with complementary foods to infants and young children 6 to 23 months of age for health, nutrition, and developmental outcomes. Cochrane Database Syst Rev. 2019 May 2;5(5):CD012611. doi: 10.1002/14651858.CD012611.pub3. PMID 31046132

Идентификаторы

NCT: NCT07451951 · 11806 · 1000001355

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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