Evidence map›Paper›PMID 30873290›Full record

ArticlePilot and feasibility studies2019

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, Gilberto Kac, Berit L Heitmann, Paulo Nadanovsky, Maria Cláudia da Veiga Soares Carvalho, Camila Benaim, Michael Maia Schlüssel, Maria Beatriz Trindade de Castro, Nadya Helena Alves-Santos, Amanda Farnum Baptista and 4 more

Erratum issued Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Pilot and feasibility studies, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03148483 (Calcium and Vitamin D Supplementation and Periodontal Therapy for Improving Metabolic and Inflammatory Profile Among Pregnant Women), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
2.2field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03148483 nacompletednot on this map

Calcium and Vitamin D Supplementation and Periodontal Therapy for Improving Metabolic and Inflammatory Profile Among Pregnant Women: a Feasibility Trial (THE IMPROVE TRIAL)

TypeinterventionalSponsorUniversity of WestminsterRan2017 to 2018Enrolled70ConditionsPeriodontitis, InflammationArmsEarly PT, Delayed PT, Fortified Milk, Plain Milk
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Vitamin D supplementation for women during pregnancy.The Cochrane database of systematic reviews · 2024
    Pooled it
  3. Trial
  4. Trial
  5. Vitamin D and Calcium Milk Fortification in Pregnant Women with Periodontitis: A Feasibility Trial.International journal of environmental research and public health · 2020
    Trial
  6. Trial
  7. Review
  8. Article
  9. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 6 institutions in 4 countries.

Paula Guedes Cocate1Department of Bioscience and Physical Activity, School of Physical Education and Sports, Rio de Janeiro Federal University, Rio de Janeiro, Brazil.
Gilberto Kac2Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.
Berit L Heitmann3Research 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.
Paulo Nadanovsky4Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro, Brazil.
Maria Cláudia da Veiga Soares Carvalho5Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Rio de Janeiro Federal University, Rio de Janeiro, Brazil.
Camila Benaim2Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.
Michael Maia Schlüssel6Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Maria Beatriz Trindade de Castro2Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.
Nadya Helena Alves-Santos2Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.
Amanda Farnum Baptista2Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.
Michael F Holick7Section of Endocrinology, Diabetes & Nutrition, Department of Medicine, Boston University School of Medicine (BUSM), Boston, MA USA.
Rana R Mokhtar8Boston University School of Medicine (BUSM), Boston, MA USA.
Alessandra Raymundo Bomfim4Institute of Social Medicine, State University of Rio de Janeiro, Rio de Janeiro, Brazil.
Amanda Rodrigues Amorim Adegboye9Department of Psychology, Social Work & Counselling, Faculty of Education and Health, University of Greenwich, Old Royal Naval College, Park Row, London, SE10 9LS UK.ORCID 0000-0003-2780-0350
Universidade Federal do Rio de Janeiro · BRBoston University · USUniversidade do Estado do Rio de Janeiro · BRFrederiksberg Hospital · DKNuffield Orthopaedic Centre · GBUniversity of Greenwich · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPeriodontitis 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.

methodsThe 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 ( 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 registrationNCT, NCT03148483. Registered on May 11, 2017.

Indexed as

CalciumFeasibility randomised controlled trialMilkPeriodontal therapyPregnant womenVitamin D

Identifiers

PMID30873290
PMCPMC6402123
OpenAlexW2934788467

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.