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| ID | Type | Description | Link |
|---|---|---|---|
| 1000001355 | Other Grant/Funding Number | United Nations World Food Programme (WFP) |
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| Name | Class |
|---|---|
| United Nations World Food Programme (WFP) | OTHER |
| Benazir Income Support Programme (BISP) | OTHER |
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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:
Researchers will compare SQ-LNS and MQ-LNS to see if SQ-LNS is as good as MQ-LNS in preventing undernutrition.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medium-quantity lipid-based nutrient supplement (MQ-LNS) | Active Comparator | Children receiving MQ-LNS |
|
| Small-quantity lipid-based nutrient supplement (SQ-LNS) | Active Comparator | Children receiving SQ-LNS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medium-quantity lipid-based nutrient supplement (MQ-LNS) | Dietary Supplement | 50 g/day lipid-based nutrient supplement providing energy and essential micronutrients, administered daily for 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Stunting | length-for-age z-score (LAZ) < -2 SD | From enrollment to the end of intervention period at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Wasting | weight-for-length z-score (WLZ) < -2 SD | From enrollment to the end of intervention period at 6 months |
| Underweight | weight-for-age z-score (WAZ) < -2 SD |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BNP Facilitation Centers | Not yet recruiting | Peshawar | Khyber Pakhtunkhwa | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37742931 | Background | 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. | |
| 34590116 | Background | 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 AJ, Prendergast AJ, Shamim AA, Siddiqui Z, Tofail F, Weber AM, Wu LSF, Dewey KG. Small-quantity lipid-based nutrient supplements for children age 6-24 months: a systematic review and individual participant data meta-analysis of effects on developmental outcomes and effect modifiers. Am J Clin Nutr. 2021 Nov 2;114(Suppl 1):43S-67S. doi: 10.1093/ajcn/nqab277. |
| Label | URL |
|---|---|
| Strategies for ensuring adequate nutrientintake for infants and young children duringthe period of complementary feeding | View source |
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De-identified individual participant data (IPD) underlying the results reported in publications will be shared.
May 2027 - May 2034
Access to de-identified IPD will be provided to researchers upon reasonable request. Data access will be subject to approval by the Principal Investigator and the ethical review committee of Aga Khan University. Data will be shared through a secure data transfer mechanism.
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The statistical analysis team will remain blinded to the intervention allocation to minimize the risk of bias.
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| Small-quantity lipid-based nutrient supplement (SQ-LNS) | Dietary Supplement | 20 g/day lipid-based nutrient supplement providing energy and essential micronutrients, administered daily for 6 months. |
|
| From enrollment to the end of intervention period at 6 months |
| Morbidity | Includes diarrhea (liquid stools defined as ≥3 loose or watery stools within 24 hour), respiratory infection (cough plus rapid, difficult breathing), vomiting, fever, rash/sores, coughing, wheezing and pneumonia. | From enrollment to the end of intervention period at 6 months |
| Prevalence of anemia | hemoglobin <11 g/dL. For mild anemia: hemoglobin 10.0 - 10.9 g/dL For moderate anemia: 7.0 - 9.9 g/dL For severe anemia: <7.0 g/dL | At enrollment and later at the end of intervention period at 6 months |
| BNP Facilitation Centers | Recruiting | Dadu | Sindh | Pakistan |
|
| 34590696 | Background | 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. |
| 30624600 | Background | 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 micronutrient status: results from 2 cluster-randomized trials in Kenya and Bangladesh. Am J Clin Nutr. 2019 Jan 1;109(1):148-164. doi: 10.1093/ajcn/nqy239. |
| 24628577 | Background | 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. |
| 28152989 | Background | 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/s12887-016-0765-9. |
| 31046132 | Background | 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. |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D006130 | Growth Disorders |
| D002100 | Cachexia |
| D000740 | Anemia |
| D013851 | Thinness |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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