Vitamin D and calcium milk fortification in pregnant women with periodontitis: A feasibility trial

Amanda Rodrigues Amorim Adegboye; Danilo Dias Santana; Paula Guedes Cocate; Camila Benaim; Pedro Paulo Teixeira Dos Santos; Berit Lilienthal Heitmann; Maria Cláudia da Veiga Soares Carvalho; Michael Maia Schlüssel; Maria Beatriz Trindade de Castro; Gilberto Kac

doi:10.3390/ijerph17218023

Vitamin D and calcium milk fortification in pregnant women with periodontitis: A feasibility trial

Amanda Rodrigues Amorim Adegboye
, Danilo Dias Santana
, Paula Guedes Cocate
, Camila Benaim
, Pedro Paulo Teixeira Dos Santos
, Berit Lilienthal Heitmann
, Maria Cláudia da Veiga Soares Carvalho
, Michael Maia Schlüssel
, Maria Beatriz Trindade de Castro
, Gilberto Kac

University of Greenwich
Universidade Federal do Rio de Janeiro
University of Copenhagen
University of Oxford

Research output: Contribution to journal › Article › peer-review

5 Citations (Scopus)

51 Downloads (Pure)

Abstract

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.

Original language	English
Article number	8023
Pages (from-to)	1-17
Number of pages	17
Journal	International Journal of Environmental Research and Public Health
Volume	17
Issue number	21
DOIs	https://doi.org/10.3390/ijerph17218023
Publication status	Published - 30 Oct 2020
Externally published	Yes

Bibliographical note

This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Funding

Funding: This work was supported by the National Council for Scientific and Technological Development (CNPq) (Grant number 401314/2014-6) from Brazil and the Danish Dairy Research Foundation in-kind donation from the Foods Ingredients from Denmark Acknowledgments: The authors thank the participants for their contribution to the study and the healthcare professional of the healthcare centre. This study was supported by the National Council for Scientific and Technological Development (CNPq) from Brazil and the Danish Dairy Research Foundation in-kind donation from the Foods Ingredients from Denmark. The content is solely the responsibility of the authors and does not necessarily represent the official views of the funders. The funders were not involved in the design and conduct of the study.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Acceptability
Adherence
Attrition rate
Feasibility
Milk fortification
Periodontal therapy
Pregnancy

ASJC Scopus subject areas

Public Health, Environmental and Occupational Health
Health, Toxicology and Mutagenesis

Access to Document

10.3390/ijerph17218023Licence: CC BY

PublishedFinal published version, 773 KBLicence: CC BY

Cite this

Adegboye, A. R. A., Santana, D. D., Cocate, P. G., Benaim, C., Dos Santos, P. P. T., Heitmann, B. L., Carvalho, M. C. D. V. S., Schlüssel, M. M., de Castro, M. B. T., & Kac, G. (2020). Vitamin D and calcium milk fortification in pregnant women with periodontitis: A feasibility trial. International Journal of Environmental Research and Public Health, 17(21), 1-17. Article 8023. https://doi.org/10.3390/ijerph17218023

Adegboye, ARA, Santana, DD, Cocate, PG, Benaim, C, Dos Santos, PPT, Heitmann, BL, Carvalho, MCDVS, Schlüssel, MM, de Castro, MBT & Kac, G 2020, 'Vitamin D and calcium milk fortification in pregnant women with periodontitis: A feasibility trial', International Journal of Environmental Research and Public Health, vol. 17, no. 21, 8023, pp. 1-17. https://doi.org/10.3390/ijerph17218023

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title = "Vitamin D and calcium milk fortification in pregnant women with periodontitis: A feasibility trial",

abstract = "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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AU - Benaim, Camila

AU - Dos Santos, Pedro Paulo Teixeira

AU - Heitmann, Berit Lilienthal

AU - Carvalho, Maria Cláudia da Veiga Soares

AU - Schlüssel, Michael Maia

AU - de Castro, Maria Beatriz Trindade

AU - Kac, Gilberto

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ER -

Vitamin D and calcium milk fortification in pregnant women with periodontitis: A feasibility trial

Abstract

Bibliographical note

Funding

UN SDGs

Keywords

ASJC Scopus subject areas

Access to Document

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Cite this