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Vitamin D and Calcium Milk Fortification in Pregnant Women with Periodontitis: A Feasibility Trial

This study aims to assess the acceptability, adherence, and retention of a feasibility trial on milk fortification with calcium and vitamin D (Ca + VitD) and periodontal therapy (PT) among low income Brazilian pregnant women with periodontitis (IMPROVE trial). This 2 × 2 factorial feasibility trial...

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Detalles Bibliográficos
Autores principales: Rodrigues Amorim Adegboye, Amanda, Dias Santana, Danilo, Guedes Cocate, Paula, Benaim, Camila, Teixeira dos Santos, Pedro Paulo, Heitmann, Berit Lilienthal, da Veiga Soares Carvalho, Maria Cláudia, Maia Schlüssel, Michael, Trindade de Castro, Maria Beatriz, Kac, Gilberto
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7662458/
https://www.ncbi.nlm.nih.gov/pubmed/33143369
http://dx.doi.org/10.3390/ijerph17218023
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author Rodrigues Amorim Adegboye, Amanda
Dias Santana, Danilo
Guedes Cocate, Paula
Benaim, Camila
Teixeira dos Santos, Pedro Paulo
Heitmann, Berit Lilienthal
da Veiga Soares Carvalho, Maria Cláudia
Maia Schlüssel, Michael
Trindade de Castro, Maria Beatriz
Kac, Gilberto
author_facet Rodrigues Amorim Adegboye, Amanda
Dias Santana, Danilo
Guedes Cocate, Paula
Benaim, Camila
Teixeira dos Santos, Pedro Paulo
Heitmann, Berit Lilienthal
da Veiga Soares Carvalho, Maria Cláudia
Maia Schlüssel, Michael
Trindade de Castro, Maria Beatriz
Kac, Gilberto
author_sort Rodrigues Amorim Adegboye, Amanda
collection PubMed
description This study aims to assess the acceptability, adherence, and retention of a feasibility trial on milk fortification with calcium and vitamin D (Ca + VitD) and periodontal therapy (PT) among low income Brazilian pregnant women with periodontitis (IMPROVE trial). This 2 × 2 factorial feasibility trial used a mixed-methods evaluation. In total, 69 pregnant women were randomly allocated to four groups: 1. fortified sachet with Ca+VitD and milk plus early PT (throughout gestation); 2. placebo and milk plus early PT; 3. fortified sachet with Ca+VitD and milk plus late PT after childbirth; 4. placebo and milk plus late PT. Data were collected via questionnaires, field notes, participant flow logs, treatment diary, and focal group discussions. Quantitative and qualitative data were analysed using appropriate descriptive statistics and content analysis, respectively. Eligibility rate (12%) was below the target of 15%, but participation (76.1%) and recruitment rate (2 women/week) exceeded the targets. Retention rate (78.6%) was slightly below the target (80%). Adherence to the PT was significantly higher in the early treatment groups (98.8%) compared to the late treatment groups (29%). All women accepted the random allocation, and baseline groups were balanced. There was no report of adverse events. This multi-component intervention is acceptable, well-tolerated, and feasible among low-risk pregnant women in Brazil.
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spelling pubmed-76624582020-11-14 Vitamin D and Calcium Milk Fortification in Pregnant Women with Periodontitis: A Feasibility Trial Rodrigues Amorim Adegboye, Amanda Dias Santana, Danilo Guedes Cocate, Paula Benaim, Camila Teixeira dos Santos, Pedro Paulo Heitmann, Berit Lilienthal da Veiga Soares Carvalho, Maria Cláudia Maia Schlüssel, Michael Trindade de Castro, Maria Beatriz Kac, Gilberto Int J Environ Res Public Health Article This study aims to assess the acceptability, adherence, and retention of a feasibility trial on milk fortification with calcium and vitamin D (Ca + VitD) and periodontal therapy (PT) among low income Brazilian pregnant women with periodontitis (IMPROVE trial). This 2 × 2 factorial feasibility trial used a mixed-methods evaluation. In total, 69 pregnant women were randomly allocated to four groups: 1. fortified sachet with Ca+VitD and milk plus early PT (throughout gestation); 2. placebo and milk plus early PT; 3. fortified sachet with Ca+VitD and milk plus late PT after childbirth; 4. placebo and milk plus late PT. Data were collected via questionnaires, field notes, participant flow logs, treatment diary, and focal group discussions. Quantitative and qualitative data were analysed using appropriate descriptive statistics and content analysis, respectively. Eligibility rate (12%) was below the target of 15%, but participation (76.1%) and recruitment rate (2 women/week) exceeded the targets. Retention rate (78.6%) was slightly below the target (80%). Adherence to the PT was significantly higher in the early treatment groups (98.8%) compared to the late treatment groups (29%). All women accepted the random allocation, and baseline groups were balanced. There was no report of adverse events. This multi-component intervention is acceptable, well-tolerated, and feasible among low-risk pregnant women in Brazil. MDPI 2020-10-30 2020-11 /pmc/articles/PMC7662458/ /pubmed/33143369 http://dx.doi.org/10.3390/ijerph17218023 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Rodrigues Amorim Adegboye, Amanda
Dias Santana, Danilo
Guedes Cocate, Paula
Benaim, Camila
Teixeira dos Santos, Pedro Paulo
Heitmann, Berit Lilienthal
da Veiga Soares Carvalho, Maria Cláudia
Maia Schlüssel, Michael
Trindade de Castro, Maria Beatriz
Kac, Gilberto
Vitamin D and Calcium Milk Fortification in Pregnant Women with Periodontitis: A Feasibility Trial
title Vitamin D and Calcium Milk Fortification in Pregnant Women with Periodontitis: A Feasibility Trial
title_full Vitamin D and Calcium Milk Fortification in Pregnant Women with Periodontitis: A Feasibility Trial
title_fullStr Vitamin D and Calcium Milk Fortification in Pregnant Women with Periodontitis: A Feasibility Trial
title_full_unstemmed Vitamin D and Calcium Milk Fortification in Pregnant Women with Periodontitis: A Feasibility Trial
title_short Vitamin D and Calcium Milk Fortification in Pregnant Women with Periodontitis: A Feasibility Trial
title_sort vitamin d and calcium milk fortification in pregnant women with periodontitis: a feasibility trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7662458/
https://www.ncbi.nlm.nih.gov/pubmed/33143369
http://dx.doi.org/10.3390/ijerph17218023
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