{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T04:44:00Z","timestamp":1793335440722,"version":"4.5.0"},"reference-count":35,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2021,3,23]],"date-time":"2021-03-23T00:00:00Z","timestamp":1616457600000},"content-version":"unspecified","delay-in-days":22,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["OPP1175213"],"award-info":[{"award-number":["OPP1175213"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,1,23]]},"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Adequate nutrition during pregnancy is crucial to both mother and child. Maternal malnutrition can be the cause of stillbirth or lead to poor birth outcomes such as preterm delivery and small-for-gestational-age newborns. There is a probable positive effect of providing pregnant women a balanced energy-protein (BEP) food supplement, but more evidence is needed. The MIcronutriments pour la SAnt\u00e9 de la M\u00e8re et de l\u2019Enfant (MISAME) III project aims to improve birth outcomes and infant growth by testing a BEP supplement during pregnancy and lactation in rural Burkina Faso. This paper describes the study protocol.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>MISAME-III is a four-arm individually randomised efficacy trial implemented in six rural health centre catchments areas in the district of Hound\u00e9. Eligible pregnant women, aged between 15 and 40 years old and living in the study areas, will be enrolled. Women will be randomly assigned to one of the four study groups: (1) prenatal intervention only, (2) postnatal intervention only, (3) prenatal and postnatal intervention or (4) no prenatal or postnatal intervention. The intervention group will receive the BEP supplement and iron\/folic acid (IFA) tablets, while the control group will only receive the IFA tablets following the national health protocol. Consumption will be supervised by trained village women on a daily basis by means of home visits. The primary outcomes are small-for-gestational age at birth and length-for-age z-score at 6\u2009months of age. Secondary outcomes will be measured at birth and during the first 6\u2009months of the infants\u2019 life. Women will be enrolled from October 2019 until the total sample size is reached.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>MISAME-III has been reviewed and approved by the University Hospital of Ghent and the ethics committee of Centre Muraz, Burkina Faso. Informed consent will be obtained. Results will be published in relevant journals and shared with other researchers and public health institutions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\" xlink:href=\"NCT03533712\">NCT03533712<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-038393","type":"journal-article","created":{"date-parts":[[2021,3,24]],"date-time":"2021-03-24T12:59:25Z","timestamp":1616590765000},"page":"e038393","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":28,"title":["Effect of balanced energy-protein supplementation during pregnancy and lactation on birth outcomes and infant growth in rural Burkina Faso: study protocol for a randomised controlled trial"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct03533712","registry":"10.18810\/clinical-trials-gov","type":"preResults"},{"clinical-trial-number":"nct03533712","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1746-7056","authenticated-orcid":false,"given":"Katrien","family":"Vanslambrouck","sequence":"first","affiliation":[{"name":"Department of Food Technology, Safety and Health, Faculty of Bioscience Engineering, Ghent University, Gent, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5267-327X","authenticated-orcid":false,"given":"Brenda","family":"de Kok","sequence":"additional","affiliation":[{"name":"Department of Food Technology, Safety and Health, Faculty of Bioscience Engineering, Ghent University, Gent, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4615-5388","authenticated-orcid":false,"given":"Laeticia Celine","family":"Toe","sequence":"additional","affiliation":[{"name":"Department of Food Technology, Safety and Health, Faculty of Bioscience Engineering, Ghent University, Gent, Belgium"},{"name":"Institut de Recherche en Sciences de la Sante, Bobo-Dioulasso, Burkina Faso"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0053-0269","authenticated-orcid":false,"given":"Nathalie","family":"De Cock","sequence":"additional","affiliation":[{"name":"Department of Food Technology, Safety and Health, Faculty of Bioscience Engineering, Ghent University, Gent, 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