Evidence map›Paper›PMID 33143369›Full record

Trial reportInternational journal of environmental research and public health2020

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

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of environmental research and public health, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 25% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 8 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. Review
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 3 countries.

Amanda Rodrigues Amorim AdegboyeSchool of Human Sciences, Faculty of Education, Health and Human Sciences, University of Greenwich, Park Row, London SE10 9 LS, UK.
Danilo Dias SantanaNutritional 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 CocateDepartment of Bioscience and Physical Activity, School of Physical Education and Sports, Federal University of Rio de Janeiro, 21941-599 Rio de Janeiro, Brazil.
Camila BenaimNutritional 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 SantosNutritional 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 HeitmannResearch 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 CarvalhoNutritional 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 SchlüsselThe 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 CastroNutritional 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 KacNutritional 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.
Universidade Federal 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

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.

Indexed as

Food, FortifiedMilkPeriodontitisPregnancy ComplicationsVitamin DVitaminsAnimalsBrazilCalcium CarbonateFeasibility StudiesFemaleHumansPregnancyPregnant PeopleCalcium CarbonateVitamin DVitaminsacceptabilityadherenceattrition ratefeasibilitymilk fortificationperiodontal therapypregnancy

Identifiers

PMID33143369
PMCPMC7662458
OpenAlexW3094908576

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.