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)

Paula Guedes Cocate¹, Gilberto Kac², Berit L Heitmann³, Paulo Nadanovsky⁴, Maria Cláudia da Veiga Soares Carvalho⁵, Camila Benaim², Michael Maia Schlüssel⁶, Maria Beatriz Trindade de Castro², Nadya Helena Alves-Santos², Amanda Farnum Baptista², Michael F Holick⁷, Rana R Mokhtar⁸, Alessandra Raymundo Bomfim⁴, Amanda Rodrigues Amorim Adegboye⁹

Affiliations

¹ 1Department of Bioscience and Physical Activity, School of Physical Education and Sports, Rio de Janeiro Federal University, Rio de Janeiro, Brazil.
² 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.
³ 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.
⁴ 4Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro, Brazil.
⁵ 5Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Rio de Janeiro Federal University, Rio de Janeiro, Brazil.
⁶ 6Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
⁷ 7Section of Endocrinology, Diabetes & Nutrition, Department of Medicine, Boston University School of Medicine (BUSM), Boston, MA USA.
⁸ 8Boston University School of Medicine (BUSM), Boston, MA USA.
⁹ 9Department of Psychology, Social Work & Counselling, Faculty of Education and Health, University of Greenwich, Old Royal Naval College, Park Row, London, SE10 9LS UK.

PMID: 30873290
PMCID: PMC6402123
DOI: 10.1186/s40814-019-0417-6

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)

Paula Guedes Cocate et al. Pilot Feasibility Stud. 2019.

. 2019 Mar 5:5:38.

doi: 10.1186/s40814-019-0417-6. eCollection 2019.

Authors

Affiliations

¹ 1Department of Bioscience and Physical Activity, School of Physical Education and Sports, Rio de Janeiro Federal University, Rio de Janeiro, Brazil.
² 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.
³ 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.
⁴ 4Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro, Brazil.
⁵ 5Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Rio de Janeiro Federal University, Rio de Janeiro, Brazil.
⁶ 6Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
⁷ 7Section of Endocrinology, Diabetes & Nutrition, Department of Medicine, Boston University School of Medicine (BUSM), Boston, MA USA.
⁸ 8Boston University School of Medicine (BUSM), Boston, MA USA.
⁹ 9Department of Psychology, Social Work & Counselling, Faculty of Education and Health, University of Greenwich, Old Royal Naval College, Park Row, London, SE10 9LS UK.

PMID: 30873290
PMCID: PMC6402123
DOI: 10.1186/s40814-019-0417-6

Erratum in

Correction to: 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 PG, Kac G, Hieitmann BL, Nadanovsky P, da Veiga Soares Carvalho MC, Benaim C, Schlüssel MM, de Castro MBT, Alves-Santos NH, Baptista AF, Holick MF, Mokhtar RR, Bomfim AR, Adegboye ARA. Cocate PG, et al. Pilot Feasibility Stud. 2020 Nov 27;6(1):187. doi: 10.1186/s40814-020-00727-6. Pilot Feasibility Stud. 2020. PMID: 33292810 Free PMC article.

Abstract

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.

Keywords: Calcium; Feasibility randomised controlled trial; Milk; Periodontal therapy; Pregnant women; Vitamin D.

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Conflict of interest statement

The study was presented to and approved by the director of the health centre where it is being conducted. Recruitment started after the IMPROVE trial protocol was submitted and approved by the Ethics Committee of School Maternity of the Federal University of Rio de Janeiro-Brazil on April 27, 2016 (certificate number 1.516.656). The study is being conducted according to the principles of Good Clinical Practice and the Declaration of Helsinki. Explanation of study procedures is given verbally to all participants and a written copy is provided in the patient information sheet. Study participation began after receipt of informed written consent. The trial was registered in the ClinicalTrials.gov database (NCT, NCT03148483. Registered 11 May 2017, https://clinicaltrials.gov/ct2/show/NCT03148483) and its recruitment began on May 2017.No applicable.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

**Fig. 1**
SPIRIT flow diagram of the IMPROVE feasibility trial

**Fig. 2**
Recruitment of participants *Pregnant women with periodontitis but presenting extensive caries were excluded

See this image and copyright information in PMC

References

1. Graves DT, Oates T, Garlet GP. Review of osteoimmunology and the host response in endodontic and periodontal lesions. J Oral Microbiol. 2011;3(5304):1–15. 10.3402/jom.v3i0.5304. - PMC - PubMed
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1. Nazir MA. Prevalence of periodontal disease, its association with systemic diseases and prevention. Int J Health Sci (Qassim) 2017;11(2):72–80. - PMC - PubMed
1. González-Jaranay M, Téllez L, Roa-López A, et al. Periodontal status during pregnancy and postpartum. PLoS One. 2017;12(5):e0178234. - PMC - PubMed
1. Vogt M, Sallum AW, Cecatti JG, et al. Factors associated with the prevalence of periodontal disease in low-risk pregnant women. Reprod Health. 2012;9:3. - PMC - PubMed

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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)

Affiliations

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)

Authors

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Erratum in

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Conflict of interest statement

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