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| Name | Class |
|---|---|
| Kamuzu University of Health Sciences | OTHER |
| University of California, Davis | OTHER |
| Bill and Melinda Gates Foundation | OTHER |
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The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. Modified versions of such supplements have been developed to improve their nutrient density and quality and to lower their costs. Such modified products have proven acceptable to infants and their guardians in Malawi and Ghana. In the present trial, the investigator aim to identify the lowest growth-promoting daily dose of modified LNS. Additionally, the investigators will test a hypothesis that LNS that does not contain milk promotes growth as well as milk-containing LNS when given for 12 months at a 10-40 g daily dose to 6-18 month old infants in rural Malawi.
Six-month old healthy infants are identified through community surveys in the study area. 1920 infants meeting set criteria are randomised into receiving the following intervention between 6 and 18 months of age: 1) standard treatment from 6-18 months (i.e.no supplements, with delayed intervention between 18-30 months of age (ST-DI), 2) 10 g / day milk-containing LNS (LNS-10gM), 3) 20 g / day milk-containing LNS (LNS-20gM), 4) 20 g / day milk-free LNS (LNS-20gNoM), 5) 40 g / day milk-containing LNS, (LNS-40gM) 6) 40 g / day milk-free LNS (LNS-40gNoM). The families receive the food supplements at 2-weekly intervals and the participants undergo a morbidity evaluation weekly, a limited development assessment at 4-weekly intervals and anthropometric evaluation at 26-week intervals and laboratory analyses at enrollment and at 18 months. Growth outcome analyses are done at 18 and at 42 months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ST-DI (Delayed intervention) | Other |
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| LNS-10gM | Experimental |
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| LNS-20gM | Experimental |
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| LNS-20gNoM | Experimental |
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| LNS-40gM |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipid-based nutrient supplement, 10gM | Dietary Supplement |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in length-for-age Z-score (LAZ, based on WHO 2005 MGRS) between enrollment and 18 months of age | Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months) | |
| Incidence of serious adverse events during the study period | 12 months after enrollment (age 18 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight-for-age (WAZ) and weight-for-length (WLZ) Z-scores | Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months) | |
| Incidence of stunting, underweight, and wasting | Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Ashorn, MD, PhD | University of Tampere Medical School | Principal Investigator |
| Kenneth Maleta, MBBS, PhD | Kamuzu University of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Malawi, College of Medicine | Mangochi | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18400716 | Background | Adu-Afarwuah S, Lartey A, Brown KH, Zlotkin S, Briend A, Dewey KG. Home fortification of complementary foods with micronutrient supplements is well accepted and has positive effects on infant iron status in Ghana. Am J Clin Nutr. 2008 Apr;87(4):929-38. doi: 10.1093/ajcn/87.4.929. | |
| 18606932 | Background | Phuka JC, Maleta K, Thakwalakwa C, Cheung YB, Briend A, Manary MJ, Ashorn P. Complementary feeding with fortified spread and incidence of severe stunting in 6- to 18-month-old rural Malawians. Arch Pediatr Adolesc Med. 2008 Jul;162(7):619-26. doi: 10.1001/archpedi.162.7.619. |
| Label | URL |
|---|---|
| College of Medicine homepage | View source |
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| LNS-40gNoM | Experimental |
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| Lipid-based nutrient supplement, 20gM | Dietary Supplement |
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| Lipid-based Nutrient Supplement, 20gNoM | Dietary Supplement |
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| Lipid-based nutrient supplement, 40gM | Dietary Supplement |
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| Lipid-based Nutrient Supplement, 40gNoM | Dietary Supplement |
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| Maize-soy flour | Dietary Supplement |
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| Prevalence of reduced appetite | Daily assessment during 12 month supplementation |
| Energy intake from complementary foods | 3 and 9 months after enrollment (age 9 and 15 months) |
| Incidence of laboratory-confirmed malaria infection | 12 months after enrollment (age 18 months) |
| Incidence of caregiver-reported morbidity | Daily assessment during 12 month supplementation |
| Immune function (measured by humoral immunity towards measles vaccination) | 12 months after enrollment (age 18 months) |
| Change in hemoglobin and micronutrient status (iron status, measured by zinc protoporphyrin (ZPP); plasma zinc; plasma vitamin A; B-vitamins and related metabolites; urine iodine | 12 months after enrollment (age 18 months) |
| Proportion with anaemia at 18 months of age | 12 months after enrollment (age 18 months) |
| Change in erythrocyte essential fatty acid (EFA) concentration (measured from a subsample of 400 participants) | 12 months after enrollment (age 18 months) |
| Neuro-behavioral development (timing of acquisition of the certain skills and more comprehensive analysis at the age of 18 months) | Limited assessment every 4 weeks during the 12 months supplementation, more comprehensive at age 18 months |
| Incidence of all adverse events during the study period | 12 months after enrollment (age 18 months) |
| 19056572 | Background | Phuka JC, Maleta K, Thakwalakwa C, Cheung YB, Briend A, Manary MJ, Ashorn P. Postintervention growth of Malawian children who received 12-mo dietary complementation with a lipid-based nutrient supplement or maize-soy flour. Am J Clin Nutr. 2009 Jan;89(1):382-90. doi: 10.3945/ajcn.2008.26483. Epub 2008 Dec 3. |
| 31010435 | Derived | Bendabenda J, Patson N, Hallamaa L, Ashorn U, Dewey KG, Ashorn P, Maleta K. Does anthropometric status at 6 months predict the over-dispersion of malaria infections in children aged 6-18 months? A prospective cohort study. Malar J. 2019 Apr 22;18(1):143. doi: 10.1186/s12936-019-2778-y. |
| 30593271 | Derived | Bendabenda J, Patson N, Hallamaa L, Mbotwa J, Mangani C, Phuka J, Prado EL, Cheung YB, Ashorn U, Dewey KG, Ashorn P, Maleta K. The association of malaria morbidity with linear growth, hemoglobin, iron status, and development in young Malawian children: a prospective cohort study. BMC Pediatr. 2018 Dec 28;18(1):396. doi: 10.1186/s12887-018-1378-2. |
| 29349922 | Derived | Kumwenda C, Hemsworth J, Phuka J, Ashorn U, Arimond M, Maleta K, Prado EL, Haskell MJ, Dewey KG, Ashorn P. Association between breast milk intake at 9-10 months of age and growth and development among Malawian young children. Matern Child Nutr. 2018 Jul;14(3):e12582. doi: 10.1111/mcn.12582. Epub 2018 Jan 19. |
| 28978680 | Derived | Adams KP, Ayifah E, Phiri TE, Mridha MK, Adu-Afarwuah S, Arimond M, Arnold CD, Cummins J, Hussain S, Kumwenda C, Matias SL, Ashorn U, Lartey A, Maleta KM, Vosti SA, Dewey KG. Maternal and Child Supplementation with Lipid-Based Nutrient Supplements, but Not Child Supplementation Alone, Decreases Self-Reported Household Food Insecurity in Some Settings. J Nutr. 2017 Dec;147(12):2309-2318. doi: 10.3945/jn.117.257386. Epub 2017 Oct 4. |
| 27474016 | Derived | Prado EL, Abbeddou S, Adu-Afarwuah S, Arimond M, Ashorn P, Ashorn U, Brown KH, Hess SY, Lartey A, Maleta K, Ocansey E, Ouedraogo JB, Phuka J, Some JW, Vosti SA, Yakes Jimenez E, Dewey KG. Linear Growth and Child Development in Burkina Faso, Ghana, and Malawi. Pediatrics. 2016 Aug;138(2):e20154698. doi: 10.1542/peds.2015-4698. |
| 26956611 | Derived | Bendabenda J, Alho L, Ashorn U, Cheung YB, Dewey KG, Vosti SA, Phuka J, Maleta K, Ashorn P. The effect of providing lipid-based nutrient supplements on morbidity in rural Malawian infants and young children: a randomized controlled trial. Public Health Nutr. 2016 Jul;19(10):1893-903. doi: 10.1017/S1368980016000331. Epub 2016 Mar 9. |
| 26740684 | Derived | Hemsworth J, Kumwenda C, Arimond M, Maleta K, Phuka J, Rehman AM, Vosti SA, Ashorn U, Filteau S, Dewey KG, Ashorn P, Ferguson EL. Lipid-Based Nutrient Supplements Increase Energy and Macronutrient Intakes from Complementary Food among Malawian Infants. J Nutr. 2016 Feb;146(2):326-34. doi: 10.3945/jn.115.215327. Epub 2016 Jan 6. |
| 26063066 | Derived | Maleta KM, Phuka J, Alho L, Cheung YB, Dewey KG, Ashorn U, Phiri N, Phiri TE, Vosti SA, Zeilani M, Kumwenda C, Bendabenda J, Pulakka A, Ashorn P. Provision of 10-40 g/d Lipid-Based Nutrient Supplements from 6 to 18 Months of Age Does Not Prevent Linear Growth Faltering in Malawi. J Nutr. 2015 Aug;145(8):1909-15. doi: 10.3945/jn.114.208181. Epub 2015 Jun 10. |
| 25995276 | Derived | Ashorn U, Alho L, Arimond M, Dewey KG, Maleta K, Phiri N, Phuka J, Vosti SA, Zeilani M, Ashorn P. Malawian Mothers Consider Lipid-Based Nutrient Supplements Acceptable for Children throughout a 1-Year Intervention, but Deviation from User Recommendations Is Common. J Nutr. 2015 Jul;145(7):1588-95. doi: 10.3945/jn.114.209593. Epub 2015 May 20. |
| 24368436 | Derived | Kumwenda C, Dewey KG, Hemsworth J, Ashorn P, Maleta K, Haskell MJ. Lipid-based nutrient supplements do not decrease breast milk intake of Malawian infants. Am J Clin Nutr. 2014 Mar;99(3):617-23. doi: 10.3945/ajcn.113.076588. Epub 2013 Dec 24. |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D006130 | Growth Disorders |
| D005183 | Failure to Thrive |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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