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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...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2020
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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. |
format | Online Article Text |
id | pubmed-7662458 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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