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 and Gilberto Kac
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Amanda Rodrigues Amorim Adegboye: School of Human Sciences, Faculty of Education, Health and Human Sciences, University of Greenwich, Park Row, London SE10 9 LS, UK
Danilo Dias Santana: Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, 21941-902 Rio de Janeiro, Brazil
Paula Guedes Cocate: Department of Bioscience and Physical Activity, School of Physical Education and Sports, Federal University of Rio de Janeiro, 21941-599 Rio de Janeiro, Brazil
Camila Benaim: Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, 21941-902 Rio de Janeiro, Brazil
Pedro Paulo Teixeira dos Santos: Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, 21941-902 Rio de Janeiro, Brazil
Berit Lilienthal Heitmann: Research Unit for Dietary Studies at the Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region, Denmark and Section for General Medicine, Institute of Public Health, Copenhagen University, 2000 Copenhagen, Denmark
Maria Cláudia da Veiga Soares Carvalho: Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, 21941-902 Rio de Janeiro, Brazil
Michael Maia Schlüssel: The EQUATOR Network–UK Centre, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Old Road, Oxford OX3 7LD, UK
Maria Beatriz Trindade de Castro: Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, 21941-902 Rio de Janeiro, Brazil
Gilberto Kac: Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, 21941-902 Rio de Janeiro, Brazil

IJERPH, 2020, vol. 17, issue 21, 1-16

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.

Keywords: feasibility; acceptability; adherence; attrition rate; periodontal therapy; milk fortification; pregnancy (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2020
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