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Supplementation with Small-Quantity Lipid-Based Nutrient Supplements Does Not Increase Child Morbidity in a Semiurban Setting in Ghana: A Secondary Outcome Noninferiority Analysis of the International Lipid-Based Nutrient Supplements (iLiNS)-DYAD Randomized Controlled Trial
BACKGROUND: Adequate knowledge about the safety of consumption of small-quantity lipid-based nutrient supplements (SQ-LNSs) is needed. OBJECTIVE: We aimed to test the hypothesis that SQ-LNS consumption is noninferior to control with respect to child morbidity METHODS: Women (n = 1320) ≤20 wk pregnan...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
ASN
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7722352/ https://www.ncbi.nlm.nih.gov/pubmed/31603205 http://dx.doi.org/10.1093/jn/nxz243 |
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author | Adu-Afarwuah, Seth Young, Rebecca R Lartey, Anna Okronipa, Harriet Ashorn, Per Ashorn, Ulla Oaks, Brietta M Dewey, Kathryn G |
author_facet | Adu-Afarwuah, Seth Young, Rebecca R Lartey, Anna Okronipa, Harriet Ashorn, Per Ashorn, Ulla Oaks, Brietta M Dewey, Kathryn G |
author_sort | Adu-Afarwuah, Seth |
collection | PubMed |
description | BACKGROUND: Adequate knowledge about the safety of consumption of small-quantity lipid-based nutrient supplements (SQ-LNSs) is needed. OBJECTIVE: We aimed to test the hypothesis that SQ-LNS consumption is noninferior to control with respect to child morbidity METHODS: Women (n = 1320) ≤20 wk pregnant were assigned to iron and folic acid until delivery with no supplementation for offspring; or multiple micronutrient supplements until 6 mo postpartum with no supplementation for offspring; or SQ-LNSs until 6 mo postpartum, and SQ-LNSs for offspring (6 mg Fe/d) from 6 to 18 mo of age [the lipid-based nutrient supplement (LNS) group]. We assessed noninferiority (margin ≤20%) between any 2 groups during 0-6 mo of age, and between the non-LNS and LNS groups during 6-18 mo of age for caregiver-reported acute respiratory infection, diarrhea, gastroenteritis, fever/suspected malaria, poor appetite, and “other illnesses.” RESULTS: During 0-6 mo of age, 1197 infants contributed 190,503 infant-days. For all morbidity combined, overall mean incidence (per 100 infant-days) was3.3 episodes, overall mean prevalence (percentage of infant-days) was 19.3%, and the 95% CIs of the incidence rate ratio (IRR) and longitudinal prevalence rate ratio (LPRR) between any 2 groups were ≤1.20. During 6-18 mo, there were 240,097 infant-days for the non-LNS group and 118,698 for the LNS group. For all morbidity combined, group mean incidences were 4.3 and 4.3, respectively (IRR: 1.0; 95% CI: 1.0, 1.1), and mean prevalences were 28.2% and 29.3%, respectively (LPRR: 1.0; 95% CI: 1.0,1.1). Noninferiority was inconclusive for diarrhea, fever/suspected malaria, and poor appetite. CONCLUSIONS: SQ-LNS consumption does not increase reported overall child morbidity in this population compared with the 2 other treatments. This trial was registered at clinicaltrials.gov as NCT00970866. J Nutr 2019;00:1-12. |
format | Online Article Text |
id | pubmed-7722352 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | ASN |
record_format | MEDLINE/PubMed |
spelling | pubmed-77223522020-12-28 Supplementation with Small-Quantity Lipid-Based Nutrient Supplements Does Not Increase Child Morbidity in a Semiurban Setting in Ghana: A Secondary Outcome Noninferiority Analysis of the International Lipid-Based Nutrient Supplements (iLiNS)-DYAD Randomized Controlled Trial Adu-Afarwuah, Seth Young, Rebecca R Lartey, Anna Okronipa, Harriet Ashorn, Per Ashorn, Ulla Oaks, Brietta M Dewey, Kathryn G J Nutr Article BACKGROUND: Adequate knowledge about the safety of consumption of small-quantity lipid-based nutrient supplements (SQ-LNSs) is needed. OBJECTIVE: We aimed to test the hypothesis that SQ-LNS consumption is noninferior to control with respect to child morbidity METHODS: Women (n = 1320) ≤20 wk pregnant were assigned to iron and folic acid until delivery with no supplementation for offspring; or multiple micronutrient supplements until 6 mo postpartum with no supplementation for offspring; or SQ-LNSs until 6 mo postpartum, and SQ-LNSs for offspring (6 mg Fe/d) from 6 to 18 mo of age [the lipid-based nutrient supplement (LNS) group]. We assessed noninferiority (margin ≤20%) between any 2 groups during 0-6 mo of age, and between the non-LNS and LNS groups during 6-18 mo of age for caregiver-reported acute respiratory infection, diarrhea, gastroenteritis, fever/suspected malaria, poor appetite, and “other illnesses.” RESULTS: During 0-6 mo of age, 1197 infants contributed 190,503 infant-days. For all morbidity combined, overall mean incidence (per 100 infant-days) was3.3 episodes, overall mean prevalence (percentage of infant-days) was 19.3%, and the 95% CIs of the incidence rate ratio (IRR) and longitudinal prevalence rate ratio (LPRR) between any 2 groups were ≤1.20. During 6-18 mo, there were 240,097 infant-days for the non-LNS group and 118,698 for the LNS group. For all morbidity combined, group mean incidences were 4.3 and 4.3, respectively (IRR: 1.0; 95% CI: 1.0, 1.1), and mean prevalences were 28.2% and 29.3%, respectively (LPRR: 1.0; 95% CI: 1.0,1.1). Noninferiority was inconclusive for diarrhea, fever/suspected malaria, and poor appetite. CONCLUSIONS: SQ-LNS consumption does not increase reported overall child morbidity in this population compared with the 2 other treatments. This trial was registered at clinicaltrials.gov as NCT00970866. J Nutr 2019;00:1-12. ASN 2019-09-11 2019 /pmc/articles/PMC7722352/ /pubmed/31603205 http://dx.doi.org/10.1093/jn/nxz243 Text en © American Society for Nutrition 2019 http://creativecommons.org/licenses/by/3.0/ This article is distributed under the terms of the Creative Commons Attribution 3.0 International License, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Article Adu-Afarwuah, Seth Young, Rebecca R Lartey, Anna Okronipa, Harriet Ashorn, Per Ashorn, Ulla Oaks, Brietta M Dewey, Kathryn G Supplementation with Small-Quantity Lipid-Based Nutrient Supplements Does Not Increase Child Morbidity in a Semiurban Setting in Ghana: A Secondary Outcome Noninferiority Analysis of the International Lipid-Based Nutrient Supplements (iLiNS)-DYAD Randomized Controlled Trial |
title | Supplementation with Small-Quantity Lipid-Based Nutrient Supplements Does Not Increase Child Morbidity in a Semiurban Setting in Ghana: A Secondary Outcome Noninferiority Analysis of the International Lipid-Based Nutrient Supplements (iLiNS)-DYAD Randomized Controlled Trial |
title_full | Supplementation with Small-Quantity Lipid-Based Nutrient Supplements Does Not Increase Child Morbidity in a Semiurban Setting in Ghana: A Secondary Outcome Noninferiority Analysis of the International Lipid-Based Nutrient Supplements (iLiNS)-DYAD Randomized Controlled Trial |
title_fullStr | Supplementation with Small-Quantity Lipid-Based Nutrient Supplements Does Not Increase Child Morbidity in a Semiurban Setting in Ghana: A Secondary Outcome Noninferiority Analysis of the International Lipid-Based Nutrient Supplements (iLiNS)-DYAD Randomized Controlled Trial |
title_full_unstemmed | Supplementation with Small-Quantity Lipid-Based Nutrient Supplements Does Not Increase Child Morbidity in a Semiurban Setting in Ghana: A Secondary Outcome Noninferiority Analysis of the International Lipid-Based Nutrient Supplements (iLiNS)-DYAD Randomized Controlled Trial |
title_short | Supplementation with Small-Quantity Lipid-Based Nutrient Supplements Does Not Increase Child Morbidity in a Semiurban Setting in Ghana: A Secondary Outcome Noninferiority Analysis of the International Lipid-Based Nutrient Supplements (iLiNS)-DYAD Randomized Controlled Trial |
title_sort | supplementation with small-quantity lipid-based nutrient supplements does not increase child morbidity in a semiurban setting in ghana: a secondary outcome noninferiority analysis of the international lipid-based nutrient supplements (ilins)-dyad randomized controlled trial |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7722352/ https://www.ncbi.nlm.nih.gov/pubmed/31603205 http://dx.doi.org/10.1093/jn/nxz243 |
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