Effect of multiple micronutrient-fortified bouillon on micronutrient status among women and children in the Northern Region of Ghana: Protocol for the Condiment Micronutrient Innovation Trial (CoMIT), a community-based randomized controlled trial.
<h4>Introduction</h4>Micronutrient deficiencies are prevalent in West Africa, particularly among women of reproductive age (WRA) and young children. Bouillon is a promising food fortification vehicle due to its widespread consumption. This study aims to evaluate the impact of multiple mi...
Saved in:
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2024-01-01
|
| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0302968 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849337655311990784 |
|---|---|
| author | Reina Engle-Stone K Ryan Wessells Marjorie J Haskell Sika M Kumordzie Charles D Arnold Jennie N Davis Emily R Becher Ahmed D Fuseini Kania W Nyaaba Xiuping Tan Katherine P Adams Georg Lietz Stephen A Vosti Seth Adu-Afarwuah |
| author_facet | Reina Engle-Stone K Ryan Wessells Marjorie J Haskell Sika M Kumordzie Charles D Arnold Jennie N Davis Emily R Becher Ahmed D Fuseini Kania W Nyaaba Xiuping Tan Katherine P Adams Georg Lietz Stephen A Vosti Seth Adu-Afarwuah |
| author_sort | Reina Engle-Stone |
| collection | DOAJ |
| description | <h4>Introduction</h4>Micronutrient deficiencies are prevalent in West Africa, particularly among women of reproductive age (WRA) and young children. Bouillon is a promising food fortification vehicle due to its widespread consumption. This study aims to evaluate the impact of multiple micronutrient-fortified bouillon cubes, compared to control bouillon cubes (fortified with iodine only), on micronutrient status and hemoglobin concentrations among lactating and non-lactating WRA and young children in northern Ghana.<h4>Methods</h4>This randomized, controlled doubly-masked trial will be conducted in the Kumbungu and Tolon districts in the Northern Region of Ghana, where prior data indicate multiple micronutrient deficiencies are common. Participants will be: 1) non-pregnant non-lactating WRA (15-49 y), 2) children 2-5 y, and 3) non-pregnant lactating women 4-18 months postpartum. Eligible participants will be randomly assigned to receive household rations of one of two types of bouillon cubes: 1) a multiple micronutrient-fortified bouillon cube containing vitamin A, folic acid, vitamin B12, iron, zinc, and iodine, or 2) a control cube containing iodine only. Each participant's household will receive a ration of bouillon cubes every 2 weeks, and households will be advised to prepare meals as usual, using the study-provided cubes. The trial duration will be 9 months for non-pregnant non-lactating WRA and children, and 3 months for lactating women. The primary outcomes will be changes in biomarkers of micronutrient status and hemoglobin among WRA and children and milk micronutrient concentrations among lactating women. Secondary outcomes will include change in prevalence of micronutrient deficiency and anemia; dietary intake of bouillon and micronutrients; inflammation, malaria, and morbidity symptoms; and child growth and development.<h4>Discussion</h4>Evidence from this study will inform discussions about bouillon fortification in Ghana and West Africa.<h4>Trial registration</h4>The trial was registered on ClinicalTrials.gov (NCT05178407) and the Pan-African Clinical Trial Registry (PACTR202206868437931). This manuscript reflects protocol version 4 (August 29, 2022). |
| format | Article |
| id | doaj-art-1376a7fa88874318af4e20afe866154d |
| institution | Kabale University |
| issn | 1932-6203 |
| language | English |
| publishDate | 2024-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj-art-1376a7fa88874318af4e20afe866154d2025-08-20T03:44:38ZengPublic Library of Science (PLoS)PLoS ONE1932-62032024-01-01195e030296810.1371/journal.pone.0302968Effect of multiple micronutrient-fortified bouillon on micronutrient status among women and children in the Northern Region of Ghana: Protocol for the Condiment Micronutrient Innovation Trial (CoMIT), a community-based randomized controlled trial.Reina Engle-StoneK Ryan WessellsMarjorie J HaskellSika M KumordzieCharles D ArnoldJennie N DavisEmily R BecherAhmed D FuseiniKania W NyaabaXiuping TanKatherine P AdamsGeorg LietzStephen A VostiSeth Adu-Afarwuah<h4>Introduction</h4>Micronutrient deficiencies are prevalent in West Africa, particularly among women of reproductive age (WRA) and young children. Bouillon is a promising food fortification vehicle due to its widespread consumption. This study aims to evaluate the impact of multiple micronutrient-fortified bouillon cubes, compared to control bouillon cubes (fortified with iodine only), on micronutrient status and hemoglobin concentrations among lactating and non-lactating WRA and young children in northern Ghana.<h4>Methods</h4>This randomized, controlled doubly-masked trial will be conducted in the Kumbungu and Tolon districts in the Northern Region of Ghana, where prior data indicate multiple micronutrient deficiencies are common. Participants will be: 1) non-pregnant non-lactating WRA (15-49 y), 2) children 2-5 y, and 3) non-pregnant lactating women 4-18 months postpartum. Eligible participants will be randomly assigned to receive household rations of one of two types of bouillon cubes: 1) a multiple micronutrient-fortified bouillon cube containing vitamin A, folic acid, vitamin B12, iron, zinc, and iodine, or 2) a control cube containing iodine only. Each participant's household will receive a ration of bouillon cubes every 2 weeks, and households will be advised to prepare meals as usual, using the study-provided cubes. The trial duration will be 9 months for non-pregnant non-lactating WRA and children, and 3 months for lactating women. The primary outcomes will be changes in biomarkers of micronutrient status and hemoglobin among WRA and children and milk micronutrient concentrations among lactating women. Secondary outcomes will include change in prevalence of micronutrient deficiency and anemia; dietary intake of bouillon and micronutrients; inflammation, malaria, and morbidity symptoms; and child growth and development.<h4>Discussion</h4>Evidence from this study will inform discussions about bouillon fortification in Ghana and West Africa.<h4>Trial registration</h4>The trial was registered on ClinicalTrials.gov (NCT05178407) and the Pan-African Clinical Trial Registry (PACTR202206868437931). This manuscript reflects protocol version 4 (August 29, 2022).https://doi.org/10.1371/journal.pone.0302968 |
| spellingShingle | Reina Engle-Stone K Ryan Wessells Marjorie J Haskell Sika M Kumordzie Charles D Arnold Jennie N Davis Emily R Becher Ahmed D Fuseini Kania W Nyaaba Xiuping Tan Katherine P Adams Georg Lietz Stephen A Vosti Seth Adu-Afarwuah Effect of multiple micronutrient-fortified bouillon on micronutrient status among women and children in the Northern Region of Ghana: Protocol for the Condiment Micronutrient Innovation Trial (CoMIT), a community-based randomized controlled trial. PLoS ONE |
| title | Effect of multiple micronutrient-fortified bouillon on micronutrient status among women and children in the Northern Region of Ghana: Protocol for the Condiment Micronutrient Innovation Trial (CoMIT), a community-based randomized controlled trial. |
| title_full | Effect of multiple micronutrient-fortified bouillon on micronutrient status among women and children in the Northern Region of Ghana: Protocol for the Condiment Micronutrient Innovation Trial (CoMIT), a community-based randomized controlled trial. |
| title_fullStr | Effect of multiple micronutrient-fortified bouillon on micronutrient status among women and children in the Northern Region of Ghana: Protocol for the Condiment Micronutrient Innovation Trial (CoMIT), a community-based randomized controlled trial. |
| title_full_unstemmed | Effect of multiple micronutrient-fortified bouillon on micronutrient status among women and children in the Northern Region of Ghana: Protocol for the Condiment Micronutrient Innovation Trial (CoMIT), a community-based randomized controlled trial. |
| title_short | Effect of multiple micronutrient-fortified bouillon on micronutrient status among women and children in the Northern Region of Ghana: Protocol for the Condiment Micronutrient Innovation Trial (CoMIT), a community-based randomized controlled trial. |
| title_sort | effect of multiple micronutrient fortified bouillon on micronutrient status among women and children in the northern region of ghana protocol for the condiment micronutrient innovation trial comit a community based randomized controlled trial |
| url | https://doi.org/10.1371/journal.pone.0302968 |
| work_keys_str_mv | AT reinaenglestone effectofmultiplemicronutrientfortifiedbouillononmicronutrientstatusamongwomenandchildreninthenorthernregionofghanaprotocolforthecondimentmicronutrientinnovationtrialcomitacommunitybasedrandomizedcontrolledtrial AT kryanwessells effectofmultiplemicronutrientfortifiedbouillononmicronutrientstatusamongwomenandchildreninthenorthernregionofghanaprotocolforthecondimentmicronutrientinnovationtrialcomitacommunitybasedrandomizedcontrolledtrial AT marjoriejhaskell effectofmultiplemicronutrientfortifiedbouillononmicronutrientstatusamongwomenandchildreninthenorthernregionofghanaprotocolforthecondimentmicronutrientinnovationtrialcomitacommunitybasedrandomizedcontrolledtrial AT sikamkumordzie effectofmultiplemicronutrientfortifiedbouillononmicronutrientstatusamongwomenandchildreninthenorthernregionofghanaprotocolforthecondimentmicronutrientinnovationtrialcomitacommunitybasedrandomizedcontrolledtrial AT charlesdarnold effectofmultiplemicronutrientfortifiedbouillononmicronutrientstatusamongwomenandchildreninthenorthernregionofghanaprotocolforthecondimentmicronutrientinnovationtrialcomitacommunitybasedrandomizedcontrolledtrial AT jenniendavis effectofmultiplemicronutrientfortifiedbouillononmicronutrientstatusamongwomenandchildreninthenorthernregionofghanaprotocolforthecondimentmicronutrientinnovationtrialcomitacommunitybasedrandomizedcontrolledtrial AT emilyrbecher effectofmultiplemicronutrientfortifiedbouillononmicronutrientstatusamongwomenandchildreninthenorthernregionofghanaprotocolforthecondimentmicronutrientinnovationtrialcomitacommunitybasedrandomizedcontrolledtrial AT ahmeddfuseini effectofmultiplemicronutrientfortifiedbouillononmicronutrientstatusamongwomenandchildreninthenorthernregionofghanaprotocolforthecondimentmicronutrientinnovationtrialcomitacommunitybasedrandomizedcontrolledtrial AT kaniawnyaaba effectofmultiplemicronutrientfortifiedbouillononmicronutrientstatusamongwomenandchildreninthenorthernregionofghanaprotocolforthecondimentmicronutrientinnovationtrialcomitacommunitybasedrandomizedcontrolledtrial AT xiupingtan effectofmultiplemicronutrientfortifiedbouillononmicronutrientstatusamongwomenandchildreninthenorthernregionofghanaprotocolforthecondimentmicronutrientinnovationtrialcomitacommunitybasedrandomizedcontrolledtrial AT katherinepadams effectofmultiplemicronutrientfortifiedbouillononmicronutrientstatusamongwomenandchildreninthenorthernregionofghanaprotocolforthecondimentmicronutrientinnovationtrialcomitacommunitybasedrandomizedcontrolledtrial AT georglietz effectofmultiplemicronutrientfortifiedbouillononmicronutrientstatusamongwomenandchildreninthenorthernregionofghanaprotocolforthecondimentmicronutrientinnovationtrialcomitacommunitybasedrandomizedcontrolledtrial AT stephenavosti effectofmultiplemicronutrientfortifiedbouillononmicronutrientstatusamongwomenandchildreninthenorthernregionofghanaprotocolforthecondimentmicronutrientinnovationtrialcomitacommunitybasedrandomizedcontrolledtrial AT sethaduafarwuah effectofmultiplemicronutrientfortifiedbouillononmicronutrientstatusamongwomenandchildreninthenorthernregionofghanaprotocolforthecondimentmicronutrientinnovationtrialcomitacommunitybasedrandomizedcontrolledtrial |