Evidence map›Paper›PMID 27549309›Full record

Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2017

The relationship between maternal self-efficacy, compliance and outcome in a trial of vitamin D supplementation in pregnancy.

M Barker, S D'Angelo, G Ntani, W Lawrence, J Baird, M Jarman, C Vogel, H Inskip, C Cooper, N C Harvey and 1 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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

10 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Vitamin D supplementation for women during pregnancy.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Vitamin D supplementation for women during pregnancy.The Cochrane database of systematic reviews · 2019
    Pooled it
  3. Pooled it
  4. Trial
  5. Article
  6. Article
  7. Impact of population-based or targeted BMD interventions on fracture incidence.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2021
    Article
  8. Review
  9. Article
  10. The importance of physical function to people with osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2017
    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

11 authors.

M BarkerMRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, SO16 6YD, UK. meb@mrc.soton.ac.uk.ORCID 0000-0003-2976-0217
S D'AngeloMRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, SO16 6YD, UK.
G NtaniMRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, SO16 6YD, UK.
W LawrenceMRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, SO16 6YD, UK.
J BairdMRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, SO16 6YD, UK.
M JarmanLi Ka Shing Centre for Health Research Innovation, Department of Agriculture, Food and Nutritional Science, University of Alberta, Edmonton, Canada.
C VogelMRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, SO16 6YD, UK.
H InskipMRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, SO16 6YD, UK.
C CooperMRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, SO16 6YD, UK.
N C HarveyMRC Lifecourse Epidemiology Unit, Southampton General Hospital, University of Southampton, Southampton, SO16 6YD, UK.
MAVIDOS Study Group

Funding

Department of Health 10/33/04Medical Research Council G0400491Medical Research Council MC_U105960371Medical Research Council MC_U147585819Medical Research Council MC_U147585824Medical Research Council MC_U147585827Medical Research Council MC_UP_A620_1014Medical Research Council MC_UU_12011/1Medical Research Council MC_UU_12011/4Medical Research Council MR/N011848/1Versus Arthritis 17702Versus Arthritis 19583Versus Arthritis 21231
6 · The paper itself

Abstract

In a randomised controlled trial of vitamin D during pregnancy, we demonstrated that women with lower self-efficacy were more likely to experience practical problems with taking the trial medication and that this was associated with lower compliance and achieved 25(OH)-vitamin D concentrations.

introductionThe relationship between self-efficacy (the belief that one can carry out a behaviour), compliance with study protocol and outcome was explored within a randomised, double-blind, placebo-controlled trial of vitamin D supplementation in pregnancy.

methodsIn the Maternal Vitamin D Osteoporosis Study (MAVIDOS) trial, women with circulating plasma 25(OH)-vitamin D of 25-100 nmol/l in early pregnancy were randomised to either 1000 IU cholecalciferol/day or matched placebo from 14 weeks until delivery. Circulating 25(OH)-vitamin D concentrations were assessed at 14 and 34 weeks' gestation. A sequential sub-sample completed Schwarzer's General Self-Efficacy Scale at 14 and 34 weeks and the Problematic Experiences of Therapy Scale at 34 weeks. Women were interviewed about their experiences of the trial and interview transcripts analysed thematically.

resultsIn 203 women, those with higher self-efficacy were less likely to experience practical problems taking the study medication (odds ratio (OR) 0.81 (95 % confidence interval (CI) 0.69-0.95), p = 0.01). Over half reported practical problems associated with poorer compliance with the protocol requiring women to take the medication daily. Compliance in women who experienced practical problems was 94 % compared with 98 % for those with no problems (p < 0.001). Poorer compliance was also associated with lower concentrations of 25(OH)-D in late pregnancy in the treatment group (β = 0.54 nmol/l (95 % CI 0.18-0.89), p = 0.003). Thematic analysis suggested common difficulties were remembering to take the medication every day and swallowing the large capsules.

conclusionsThese findings suggest that differences in self-efficacy influence trial outcomes. Such information may help clinicians anticipate responses to routine vitamin D supplementation in pregnancy and identify those who may need more support to comply.

trial registrationISRCTN82927713, registered 11/04/2008.

Indexed as

Dietary SupplementsDrug MonitoringSelf EfficacyAdolescentAdultChildCholecalciferolDouble-Blind MethodFemaleHumansMiddle AgedPregnancyPregnancy ComplicationsPrenatal CareTreatment OutcomeVitamin D25-hydroxyvitamin DCholecalciferolVitamin DCompliancePregnancyRandomised controlled trialSelf-efficacyVitamin D

Identifiers

PMID27549309
PMCPMC5404713

What OpenQuestion holds

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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.