Role of L-Carnitine supplementation on rate of weight gain and biomarkers of Environmental Enteric Dysfunction in children with severe acute malnutrition: A protocol for a double-blinded randomized controlled trial
Severe acute malnutrition (SAM) and environmental enteric dysfunction (EED) are highly prevalent among children residing in resource-limited countries like Bangladesh. L-carnitine may play a role in improving the growth and ameliorating the EED among nutritionally vulnerable children. To investigate...
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| creator | Alam, Jinat Islam, Md Ridwan Fahim, Shah Mohammad Gazi, Md Amran Ahmed, Tahmeed |
| description | Severe acute malnutrition (SAM) and environmental enteric dysfunction (EED) are highly prevalent among children residing in resource-limited countries like Bangladesh. L-carnitine may play a role in improving the growth and ameliorating the EED among nutritionally vulnerable children.
To investigate the role of L-carnitine supplementation on the rate of weight gain, duration of hospital stays, and EED biomarkers among children with severe acute malnutrition.
This study is a double-blinded, placebo-controlled, randomized clinical trial aiming to enroll diarrheal children with SAM between 9-24 months of both sexes attending the nutritional rehabilitation unit (NRU) of Dhaka Hospital of icddr,b. It is an ongoing trial including two arms where one arm receives L-carnitine supplementation, and the other arms receive a placebo for 15 days in addition to the existing standard treatment of SAM. The primary outcome is the rate of weight gain, and the secondary outcomes include duration of hospital stay and EED biomarkers. Outcomes are assessed at baseline and 15 days of post-intervention. We hypothesize that the L- carnitine supplementation for 15 days in children with SAM will improve the rate of weight gain and biomarkers of EED.
ClinicalTrials.gov # NCT05083637. Date of registration: October 19, 2021. |
| doi_str_mv | 10.1371/journal.pone.0275291 |
| format | Article |
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To investigate the role of L-carnitine supplementation on the rate of weight gain, duration of hospital stays, and EED biomarkers among children with severe acute malnutrition.
This study is a double-blinded, placebo-controlled, randomized clinical trial aiming to enroll diarrheal children with SAM between 9-24 months of both sexes attending the nutritional rehabilitation unit (NRU) of Dhaka Hospital of icddr,b. It is an ongoing trial including two arms where one arm receives L-carnitine supplementation, and the other arms receive a placebo for 15 days in addition to the existing standard treatment of SAM. The primary outcome is the rate of weight gain, and the secondary outcomes include duration of hospital stay and EED biomarkers. Outcomes are assessed at baseline and 15 days of post-intervention. We hypothesize that the L- carnitine supplementation for 15 days in children with SAM will improve the rate of weight gain and biomarkers of EED.
ClinicalTrials.gov # NCT05083637. Date of registration: October 19, 2021.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0275291</identifier><identifier>PMID: 36178918</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Age ; Analysis ; Bangladesh ; Biological markers ; Biology and Life Sciences ; Biomarkers ; Care and treatment ; Carnitine ; Carnitine - therapeutic use ; Child ; Children ; Children & youth ; Clinical trials ; Data collection ; Diarrhea ; Dietary Supplements ; Enrollments ; Families & family life ; Female ; Health aspects ; Hospitals ; Humans ; Intervention ; L-Carnitine ; Levocarnitine ; Male ; Malnutrition ; Malnutrition in children ; Medicine and Health Sciences ; People and Places ; Placebos ; Pneumonia ; Randomized Controlled Trials as Topic ; Rehabilitation ; Severe Acute Malnutrition ; Study Protocol ; Treatment Outcome ; Weight Gain</subject><ispartof>PloS one, 2022-09, Vol.17 (9), p.e0275291</ispartof><rights>COPYRIGHT 2022 Public Library of Science</rights><rights>2022 Alam et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2022 Alam et al 2022 Alam et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-b424b06acac46ec01bd0cbbe91e5348923a190859509f87a6aec5ab972c780e93</citedby><cites>FETCH-LOGICAL-c692t-b424b06acac46ec01bd0cbbe91e5348923a190859509f87a6aec5ab972c780e93</cites><orcidid>0000-0002-3627-202X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9524645/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9524645/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,2915,23845,27901,27902,53766,53768,79342,79343</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36178918$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Alam, Jinat</creatorcontrib><creatorcontrib>Islam, Md Ridwan</creatorcontrib><creatorcontrib>Fahim, Shah Mohammad</creatorcontrib><creatorcontrib>Gazi, Md Amran</creatorcontrib><creatorcontrib>Ahmed, Tahmeed</creatorcontrib><title>Role of L-Carnitine supplementation on rate of weight gain and biomarkers of Environmental Enteric Dysfunction in children with severe acute malnutrition: A protocol for a double-blinded randomized controlled trial</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Severe acute malnutrition (SAM) and environmental enteric dysfunction (EED) are highly prevalent among children residing in resource-limited countries like Bangladesh. L-carnitine may play a role in improving the growth and ameliorating the EED among nutritionally vulnerable children.
To investigate the role of L-carnitine supplementation on the rate of weight gain, duration of hospital stays, and EED biomarkers among children with severe acute malnutrition.
This study is a double-blinded, placebo-controlled, randomized clinical trial aiming to enroll diarrheal children with SAM between 9-24 months of both sexes attending the nutritional rehabilitation unit (NRU) of Dhaka Hospital of icddr,b. It is an ongoing trial including two arms where one arm receives L-carnitine supplementation, and the other arms receive a placebo for 15 days in addition to the existing standard treatment of SAM. The primary outcome is the rate of weight gain, and the secondary outcomes include duration of hospital stay and EED biomarkers. Outcomes are assessed at baseline and 15 days of post-intervention. We hypothesize that the L- carnitine supplementation for 15 days in children with SAM will improve the rate of weight gain and biomarkers of EED.
ClinicalTrials.gov # NCT05083637. Date of registration: October 19, 2021.</description><subject>Age</subject><subject>Analysis</subject><subject>Bangladesh</subject><subject>Biological markers</subject><subject>Biology and Life Sciences</subject><subject>Biomarkers</subject><subject>Care and treatment</subject><subject>Carnitine</subject><subject>Carnitine - therapeutic use</subject><subject>Child</subject><subject>Children</subject><subject>Children & youth</subject><subject>Clinical trials</subject><subject>Data collection</subject><subject>Diarrhea</subject><subject>Dietary Supplements</subject><subject>Enrollments</subject><subject>Families & family life</subject><subject>Female</subject><subject>Health aspects</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Intervention</subject><subject>L-Carnitine</subject><subject>Levocarnitine</subject><subject>Male</subject><subject>Malnutrition</subject><subject>Malnutrition in children</subject><subject>Medicine and Health 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of L-Carnitine supplementation on rate of weight gain and biomarkers of Environmental Enteric Dysfunction in children with severe acute malnutrition: A protocol for a double-blinded randomized controlled trial</title><author>Alam, Jinat ; Islam, Md Ridwan ; Fahim, Shah Mohammad ; Gazi, Md Amran ; Ahmed, Tahmeed</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c692t-b424b06acac46ec01bd0cbbe91e5348923a190859509f87a6aec5ab972c780e93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Age</topic><topic>Analysis</topic><topic>Bangladesh</topic><topic>Biological markers</topic><topic>Biology and Life Sciences</topic><topic>Biomarkers</topic><topic>Care and treatment</topic><topic>Carnitine</topic><topic>Carnitine - therapeutic use</topic><topic>Child</topic><topic>Children</topic><topic>Children & youth</topic><topic>Clinical trials</topic><topic>Data 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Shah Mohammad</au><au>Gazi, Md Amran</au><au>Ahmed, Tahmeed</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Role of L-Carnitine supplementation on rate of weight gain and biomarkers of Environmental Enteric Dysfunction in children with severe acute malnutrition: A protocol for a double-blinded randomized controlled trial</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2022-09-30</date><risdate>2022</risdate><volume>17</volume><issue>9</issue><spage>e0275291</spage><pages>e0275291-</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Severe acute malnutrition (SAM) and environmental enteric dysfunction (EED) are highly prevalent among children residing in resource-limited countries like Bangladesh. L-carnitine may play a role in improving the growth and ameliorating the EED among nutritionally vulnerable children.
To investigate the role of L-carnitine supplementation on the rate of weight gain, duration of hospital stays, and EED biomarkers among children with severe acute malnutrition.
This study is a double-blinded, placebo-controlled, randomized clinical trial aiming to enroll diarrheal children with SAM between 9-24 months of both sexes attending the nutritional rehabilitation unit (NRU) of Dhaka Hospital of icddr,b. It is an ongoing trial including two arms where one arm receives L-carnitine supplementation, and the other arms receive a placebo for 15 days in addition to the existing standard treatment of SAM. The primary outcome is the rate of weight gain, and the secondary outcomes include duration of hospital stay and EED biomarkers. Outcomes are assessed at baseline and 15 days of post-intervention. We hypothesize that the L- carnitine supplementation for 15 days in children with SAM will improve the rate of weight gain and biomarkers of EED.
ClinicalTrials.gov # NCT05083637. Date of registration: October 19, 2021.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>36178918</pmid><doi>10.1371/journal.pone.0275291</doi><tpages>e0275291</tpages><orcidid>https://orcid.org/0000-0002-3627-202X</orcidid><oa>free_for_read</oa></addata></record> |
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| source | Public Library of Science (PLoS) Journals Open Access; MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Age Analysis Bangladesh Biological markers Biology and Life Sciences Biomarkers Care and treatment Carnitine Carnitine - therapeutic use Child Children Children & youth Clinical trials Data collection Diarrhea Dietary Supplements Enrollments Families & family life Female Health aspects Hospitals Humans Intervention L-Carnitine Levocarnitine Male Malnutrition Malnutrition in children Medicine and Health Sciences People and Places Placebos Pneumonia Randomized Controlled Trials as Topic Rehabilitation Severe Acute Malnutrition Study Protocol Treatment Outcome Weight Gain |
| title | Role of L-Carnitine supplementation on rate of weight gain and biomarkers of Environmental Enteric Dysfunction in children with severe acute malnutrition: A protocol for a double-blinded randomized controlled trial |
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