Comparison of two forms of daily preventive zinc supplementation versus therapeutic zinc supplementation for diarrhea on young children’s physical growth and risk of infection: study design and rationale for a randomized controlled trial
Abstract Background Zinc is an essential nutrient that is required for children’s normal growth and resistance to infections, including diarrhea and pneumonia, two major causes of child mortality. Daily or weekly preventive zinc supplementation has been shown to improve growth and reduce the risk of...
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| Format: | Article |
| Language: | English |
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BMC
2018-11-01
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| Series: | BMC Nutrition |
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| Online Access: | http://link.springer.com/article/10.1186/s40795-018-0247-6 |
| _version_ | 1819114432830111744 |
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| author | K. Ryan Wessells Kenneth H. Brown Sengchanh Kounnavong Maxwell A. Barffour Guy-Marino Hinnouho Somphou Sayasone Charles B. Stephensen Kethmany Ratsavong Charles P. Larson Charles D. Arnold Kimberly B. Harding Gregory A. Reinhart Ganjana Lertmemongkolchai Supan Fucharoen Robin M. Bernstein Sonja Y. Hess |
| author_facet | K. Ryan Wessells Kenneth H. Brown Sengchanh Kounnavong Maxwell A. Barffour Guy-Marino Hinnouho Somphou Sayasone Charles B. Stephensen Kethmany Ratsavong Charles P. Larson Charles D. Arnold Kimberly B. Harding Gregory A. Reinhart Ganjana Lertmemongkolchai Supan Fucharoen Robin M. Bernstein Sonja Y. Hess |
| author_sort | K. Ryan Wessells |
| collection | DOAJ |
| description | Abstract Background Zinc is an essential nutrient that is required for children’s normal growth and resistance to infections, including diarrhea and pneumonia, two major causes of child mortality. Daily or weekly preventive zinc supplementation has been shown to improve growth and reduce the risk of infection, while therapeutic zinc supplementation for 10–14 days is recommended for the treatment of diarrhea. The overall objective of the present study is to compare several regimens for delivering zinc to young children, both for the prevention of zinc deficiency and the treatment of diarrhea. Methods The present study is a community-based, randomized controlled trial in the Lao People’s Democratic Republic (PDR). Three thousand, four hundred children 6–23 months of age will be randomized to one of four intervention groups (daily preventive zinc dispersible tablet, daily preventive multiple micronutrient powder, therapeutic zinc dispersible tablet for diarrhea, or placebo control); interventions will be delivered for 9 months and outcomes measured at pre-determined intervals. Primary outcomes include physical growth (length and weight), diarrhea incidence, hemoglobin and micronutrient status, and innate and adaptive immune function. Secondary outcomes include mid-upper-arm circumference, neuro-behavioral development, hair cortisol concentrations, markers of intestinal inflammation and parasite burden. Incidence of adverse events and the modifying effects of inherited hemoglobin disorders and iron status on the response to the intervention will also be examined. We will estimate unadjusted effects and effects adjusted for selected baseline covariates using ANCOVA. Discussion Many countries are now rolling out large-scale programs to include therapeutic zinc supplementation in the treatment of childhood diarrhea, but few have established programs demonstrated to be effective in the prevention of zinc deficiency. This study will address how best to deliver supplemental zinc to prevent zinc deficiency and reduce the severity of diarrhea-related health complications. Trial registration Trial registration identifier (NCT02428647) ; Date of registration: April 29, 2015. |
| first_indexed | 2024-12-22T04:45:13Z |
| format | Article |
| id | doaj.art-f0c596b1678c4a2583a97f6ccc253af0 |
| institution | Directory Open Access Journal |
| issn | 2055-0928 |
| language | English |
| last_indexed | 2024-12-22T04:45:13Z |
| publishDate | 2018-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Nutrition |
| spelling | doaj.art-f0c596b1678c4a2583a97f6ccc253af02022-12-21T18:38:38ZengBMCBMC Nutrition2055-09282018-11-014111910.1186/s40795-018-0247-6Comparison of two forms of daily preventive zinc supplementation versus therapeutic zinc supplementation for diarrhea on young children’s physical growth and risk of infection: study design and rationale for a randomized controlled trialK. Ryan Wessells0Kenneth H. Brown1Sengchanh Kounnavong2Maxwell A. Barffour3Guy-Marino Hinnouho4Somphou Sayasone5Charles B. Stephensen6Kethmany Ratsavong7Charles P. Larson8Charles D. Arnold9Kimberly B. Harding10Gregory A. Reinhart11Ganjana Lertmemongkolchai12Supan Fucharoen13Robin M. Bernstein14Sonja Y. Hess15Program in International and Community Nutrition, Department of Nutrition, University of CaliforniaProgram in International and Community Nutrition, Department of Nutrition, University of CaliforniaNational Institute of Public Health, Ministry of HealthProgram in International and Community Nutrition, Department of Nutrition, University of CaliforniaProgram in International and Community Nutrition, Department of Nutrition, University of CaliforniaNational Institute of Public Health, Ministry of HealthUnited States Department of Agriculture, Western Human Nutrition Research CenterNational Institute of Public Health, Ministry of HealthCanadian Coalition for Global Health ResearchProgram in International and Community Nutrition, Department of Nutrition, University of CaliforniaNutrition International, formerly The Micronutrient InitiativeThe Mathile Institute for the Advancement of Human NutritionCentre for Research and Development of Medical Diagnostics Laboratories, Faculty of Associated Medical Sciences, Khon Kaen UniversityCentre for Research and Development of Medical Diagnostics Laboratories, Faculty of Associated Medical Sciences, Khon Kaen UniversityDepartment of Anthropology, University of ColoradoProgram in International and Community Nutrition, Department of Nutrition, University of CaliforniaAbstract Background Zinc is an essential nutrient that is required for children’s normal growth and resistance to infections, including diarrhea and pneumonia, two major causes of child mortality. Daily or weekly preventive zinc supplementation has been shown to improve growth and reduce the risk of infection, while therapeutic zinc supplementation for 10–14 days is recommended for the treatment of diarrhea. The overall objective of the present study is to compare several regimens for delivering zinc to young children, both for the prevention of zinc deficiency and the treatment of diarrhea. Methods The present study is a community-based, randomized controlled trial in the Lao People’s Democratic Republic (PDR). Three thousand, four hundred children 6–23 months of age will be randomized to one of four intervention groups (daily preventive zinc dispersible tablet, daily preventive multiple micronutrient powder, therapeutic zinc dispersible tablet for diarrhea, or placebo control); interventions will be delivered for 9 months and outcomes measured at pre-determined intervals. Primary outcomes include physical growth (length and weight), diarrhea incidence, hemoglobin and micronutrient status, and innate and adaptive immune function. Secondary outcomes include mid-upper-arm circumference, neuro-behavioral development, hair cortisol concentrations, markers of intestinal inflammation and parasite burden. Incidence of adverse events and the modifying effects of inherited hemoglobin disorders and iron status on the response to the intervention will also be examined. We will estimate unadjusted effects and effects adjusted for selected baseline covariates using ANCOVA. Discussion Many countries are now rolling out large-scale programs to include therapeutic zinc supplementation in the treatment of childhood diarrhea, but few have established programs demonstrated to be effective in the prevention of zinc deficiency. This study will address how best to deliver supplemental zinc to prevent zinc deficiency and reduce the severity of diarrhea-related health complications. Trial registration Trial registration identifier (NCT02428647) ; Date of registration: April 29, 2015.http://link.springer.com/article/10.1186/s40795-018-0247-6ZincDiarrheaMicronutrientSupplementationHome-fortificationGrowth |
| spellingShingle | K. Ryan Wessells Kenneth H. Brown Sengchanh Kounnavong Maxwell A. Barffour Guy-Marino Hinnouho Somphou Sayasone Charles B. Stephensen Kethmany Ratsavong Charles P. Larson Charles D. Arnold Kimberly B. Harding Gregory A. Reinhart Ganjana Lertmemongkolchai Supan Fucharoen Robin M. Bernstein Sonja Y. Hess Comparison of two forms of daily preventive zinc supplementation versus therapeutic zinc supplementation for diarrhea on young children’s physical growth and risk of infection: study design and rationale for a randomized controlled trial BMC Nutrition Zinc Diarrhea Micronutrient Supplementation Home-fortification Growth |
| title | Comparison of two forms of daily preventive zinc supplementation versus therapeutic zinc supplementation for diarrhea on young children’s physical growth and risk of infection: study design and rationale for a randomized controlled trial |
| title_full | Comparison of two forms of daily preventive zinc supplementation versus therapeutic zinc supplementation for diarrhea on young children’s physical growth and risk of infection: study design and rationale for a randomized controlled trial |
| title_fullStr | Comparison of two forms of daily preventive zinc supplementation versus therapeutic zinc supplementation for diarrhea on young children’s physical growth and risk of infection: study design and rationale for a randomized controlled trial |
| title_full_unstemmed | Comparison of two forms of daily preventive zinc supplementation versus therapeutic zinc supplementation for diarrhea on young children’s physical growth and risk of infection: study design and rationale for a randomized controlled trial |
| title_short | Comparison of two forms of daily preventive zinc supplementation versus therapeutic zinc supplementation for diarrhea on young children’s physical growth and risk of infection: study design and rationale for a randomized controlled trial |
| title_sort | comparison of two forms of daily preventive zinc supplementation versus therapeutic zinc supplementation for diarrhea on young children s physical growth and risk of infection study design and rationale for a randomized controlled trial |
| topic | Zinc Diarrhea Micronutrient Supplementation Home-fortification Growth |
| url | http://link.springer.com/article/10.1186/s40795-018-0247-6 |
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