Evidence map›Paper›PMID 26170014›Full record

Trial reportTrials2015

An internal pilot study for a randomized trial aimed at evaluating the effectiveness of iron interventions in children with non-anemic iron deficiency: the OptEC trial.

Kawsari Abdullah, Kevin E Thorpe, Eva Mamak, Jonathon L Maguire, Catherine S Birken, Darcy Fehlings, Anthony J Hanley, Colin Macarthur, Stanley H Zlotkin, Patricia C Parkin

Registry-linked trialOpen access · goldAbstract readMulticenter StudyPragmatic Clinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01481766 (Optimizing Early Child Development in the Primary Care Practice Setting), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.8field-weighted citation impact, top 24% 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.

NCT01481766 nacompletednot on this map

Optimizing Early Child Development in the Primary Care Practice Setting: Pragmatic Randomized Trial of Iron Treatment for Young Children With Non-anemic Iron Deficiency (OptEC)

TypeinterventionalSponsorThe Hospital for Sick ChildrenRan2012 to 2018Enrolled127ConditionsNon-anemic Iron DeficiencyArmsFerrous Sulfate, Placebo, Dietary counseling
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
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 3 institutions in 1 country.

Kawsari AbdullahDivision of Pediatric Medicine, Department of Pediatrics, Pediatrics Outcomes Research Team, The Hospital for Sick Children, Room 109708, 10th Floor, 555 University Avenue, M5G 1X8, Toronto, ON, Canada. kawsari.abdullah@sickkids.ca.
Kevin E ThorpeThe Applied Health Research Centre, Li Ka Shing Knowledge Institute of St. Michael's Hospital, 30 Bond Street, M5B 1W8, Toronto, ON, Canada. kevin.thorpe@utoronto.ca.
Eva MamakDepartment of Psychology, The Hospital for Sick Children, 555 University Avenue, M5G 1X8, Toronto, ON, Canada. eva.mamak@sickkids.ca.
Jonathon L MaguireDivision of Pediatric Medicine, Department of Pediatrics, Pediatrics Outcomes Research Team, The Hospital for Sick Children, Room 109708, 10th Floor, 555 University Avenue, M5G 1X8, Toronto, ON, Canada. jonathon.maguire@utoronto.ca.
Catherine S BirkenDivision of Pediatric Medicine, Department of Pediatrics, Pediatrics Outcomes Research Team, The Hospital for Sick Children, Room 109708, 10th Floor, 555 University Avenue, M5G 1X8, Toronto, ON, Canada. catherine.birken@sickkids.ca.
Darcy FehlingsInstitute of Health Policy, Management and Evaluation, University of Toronto, 155 College Street Suite 425, M5T 3M6, Toronto, Canada. dfehlings@hollandbloorview.ca.
Anthony J HanleyDalla Lana School of Public Health, University of Toronto, 155 College Street 6th floor, M5T 3M7, Toronto, Canada. anthony.hanley@utoronto.ca.
Colin MacarthurDivision of Pediatric Medicine, Department of Pediatrics, Pediatrics Outcomes Research Team, The Hospital for Sick Children, Room 109708, 10th Floor, 555 University Avenue, M5G 1X8, Toronto, ON, Canada. colin.macarthur@sickkids.ca.
Stanley H ZlotkinDalla Lana School of Public Health, University of Toronto, 155 College Street 6th floor, M5T 3M7, Toronto, Canada. Stanley.zlotkin@sickkids.ca.
Patricia C ParkinDivision of Pediatric Medicine, Department of Pediatrics, Pediatrics Outcomes Research Team, The Hospital for Sick Children, Room 109708, 10th Floor, 555 University Avenue, M5G 1X8, Toronto, ON, Canada. patricia.parkin@sickkids.ca.
University of Toronto · CAHospital for Sick Children · CASt. Michael's Hospital · CA

Funding

Canadian Institutes of Health Research FRN 115059
6 · The paper itself

Abstract

backgroundThe OptEC trial aims to evaluate the effectiveness of oral iron in young children with non-anemic iron deficiency (NAID). The initial sample size calculated for the OptEC trial ranged from 112-198 subjects. Given the uncertainty regarding the parameters used to calculate the sample, an internal pilot study was conducted. The objectives of this internal pilot study were to obtain reliable estimate of parameters (standard deviation and design factor) to recalculate the sample size and to assess the adherence rate and reasons for non-adherence in children enrolled in the pilot study.

methodsThe first 30 subjects enrolled into the OptEC trial constituted the internal pilot study. The primary outcome of the OptEC trial is the Early Learning Composite (ELC). For estimation of the SD of the ELC, descriptive statistics of the 4 month follow-up ELC scores were assessed within each intervention group. The observed SD within each group was then pooled to obtain an estimated SD (S2) of the ELC. Correlation (ρ) between the ELC measured at baseline and follow-up was assessed. Recalculation of the sample size was performed using analysis of covariance (ANCOVA) method which uses the design factor (1- ρ(2)). Adherence rate was calculated using a parent reported rate of missed doses of the study intervention.

conclusionThe new estimate of the SD of the ELC was found to be 17.40 (S2). The design factor was (1- ρ2) = 0.21. Using a significance level of 5%, power of 80%, S2 = 17.40 and effect estimate (Δ) ranging from 6-8 points, the new sample size based on ANCOVA method ranged from 32-56 subjects (16-28 per group). Adherence ranged between 14% and 100% with 44% of the children having an adherence rate ≥ 86%. Information generated from our internal pilot study was used to update the design of the full and definitive trial, including recalculation of sample size, determination of the adequacy of adherence, and application of strategies to improve adherence.

trial registrationClinicalTrials.gov Identifier: NCT01481766 (date of registration: November 22, 2011).

Indexed as

Child DevelopmentDietary SupplementsIron DeficienciesAdministration, OralAge FactorsBiomarkersChild, PreschoolCognitionDeficiency DiseasesFemaleHumansInfantIronMaleMedication AdherenceMotor SkillsBiomarkersIron

Identifiers

PMID26170014
PMCPMC4501099
OpenAlexW2152313890

What OpenQuestion holds

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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.