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Calcium and vitamin D supplementation and/or periodontal therapy in the treatment of periodontitis among Brazilian pregnant women: protocol of a feasibility randomised controlled trial (the IMPROVE trial).
Cocate, Paula Guedes; Kac, Gilberto; Heitmann, Berit L; Nadanovsky, Paulo; da Veiga Soares Carvalho, Maria Cláudia; Benaim, Camila; Schlüssel, Michael Maia; de Castro, Maria Beatriz Trindade; Alves-Santos, Nadya Helena; Baptista, Amanda Farnum; Holick, Michael F; Mokhtar, Rana R; Bomfim, Alessandra Raymundo; Adegboye, Amanda Rodrigues Amorim.
Afiliación
  • Cocate PG; 1Department of Bioscience and Physical Activity, School of Physical Education and Sports, Rio de Janeiro Federal University, Rio de Janeiro, Brazil.
  • Kac G; 2Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.
  • Heitmann BL; 3Research 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, Denmark.
  • Nadanovsky P; 4Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro, Brazil.
  • da Veiga Soares Carvalho MC; 5Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Rio de Janeiro Federal University, Rio de Janeiro, Brazil.
  • Benaim C; 2Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.
  • Schlüssel MM; 6Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
  • de Castro MBT; 2Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.
  • Alves-Santos NH; 2Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.
  • Baptista AF; 2Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.
  • Holick MF; 7Section of Endocrinology, Diabetes & Nutrition, Department of Medicine, Boston University School of Medicine (BUSM), Boston, MA USA.
  • Mokhtar RR; 8Boston University School of Medicine (BUSM), Boston, MA USA.
  • Bomfim AR; 4Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro, Brazil.
  • Adegboye ARA; 9Department of Psychology, Social Work & Counselling, Faculty of Education and Health, University of Greenwich, Old Royal Naval College, Park Row, London, SE10 9LS UK.
Article en En | MEDLINE | ID: mdl-30873290
BACKGROUND: Periodontitis is a common oral inflammation, which is a risk factor for adverse pregnancy outcomes. Intakes of vitamin D and calcium are inversely associated with occurrence and progression of periodontitis. This study aims to assess the feasibility of a multi-component intervention, including provision of milk powder supplemented with calcium and vitamin D and periodontal therapy (PT), for improving maternal periodontal health and metabolic and inflammatory profiles of low-income Brazilian pregnant women with periodontitis. METHODS: The IMPROVE trial is a feasibility randomised controlled trial (RCT) with a 2 × 2 factorial design with a parallel process evaluation. Pregnant women with periodontitis, aged 18-40 years and with < 20 gestational weeks (n = 120) were recruited and randomly allocated into four groups: (1) fortified sachet (vitamin D and calcium) and powdered milk plus PT during pregnancy, (2) placebo sachet and powdered milk plus PT during pregnancy, (3) fortified sachet (vitamin D and calcium) and powdered milk plus PT after delivery and (4) placebo sachet and powdered milk plus PT after delivery. Dentists and participants are blinded to fortification. Acceptability of study design, recruitment strategy, random allocation, data collection procedures, recruitment rate, adherence and attrition rate will be evaluated. Data on serum levels of vitamin D, calcium and inflammatory biomarkers; clinical periodontal measurements; anthropometric measurements; and socio-demographic questionnaires are collected at baseline, third trimester and 6-8 weeks postpartum. Qualitative data are collected using focus group, for analysis of favourable factors and barriers related to study adherence. DISCUSSION: Oral health and mineral/vitamin supplementation are much overlooked in the public prenatal assistance in Brazil and of scarcity of clinical trials addressing these issues in low and middle-income countries,. To fill this gap the present study was designed to assess the feasibility of a RCT on acceptability of a multi-component intervention combining conventional periodontal treatment and consumption of milk fortified with calcium-vitamin D for improving periodontal conditions and maternal metabolic and inflammation status, among Brazilian low-income pregnant women with periodontitis. Thus, we hope that this relatively low-cost and safe multicomponent intervention can help reduce inflammation, improve maternal periodontal health and metabolic profile and consequently prevent negative gestational outcomes. TRIAL REGISTRATION: NCT, NCT03148483. Registered on May 11, 2017.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials / Guideline / Qualitative_research / Risk_factors_studies País/Región como asunto: America do sul / Brasil Idioma: En Revista: Pilot Feasibility Stud Año: 2019 Tipo del documento: Article País de afiliación: Brasil Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials / Guideline / Qualitative_research / Risk_factors_studies País/Región como asunto: America do sul / Brasil Idioma: En Revista: Pilot Feasibility Stud Año: 2019 Tipo del documento: Article País de afiliación: Brasil Pais de publicación: Reino Unido