Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001948280
Ethics application status
Approved
Date submitted
19/11/2018
Date registered
30/11/2018
Date last updated
30/11/2018
Date data sharing statement initially provided
30/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of vitamin D3 levels and morphotic parameters of blood in prematurely born children at six years of age
Scientific title
Evaluation of vitamin D3 levels and morphotic parameters of blood in prematurely born children at six years of age
Secondary ID [1] 296629 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia 310450 0
Rickets 310453 0
Condition category
Condition code
Metabolic and Endocrine 309172 309172 0 0
Other metabolic disorders
Musculoskeletal 309346 309346 0 0
Other muscular and skeletal disorders
Blood 309347 309347 0 0
Anaemia
Reproductive Health and Childbirth 309348 309348 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All measurements were taken between March and May 2017 at the Institute of Physiotherapy and Centre of Medical Innovative Research being parts of University of Rzeszow, Poland.
At first, we analyzed perinatal questionnaires at local hospitals and clinics and then selected children born of premature deliveries.
The following criteria for including into the study group were adopted: guardians’ and children’s consent for participation, birth before gestational age of 32 weeks, lack of neurologic and orthopaedic disorders. Inclusion criteria for the controls were as follows: guardians’ and children’s consent for participation, lack of neurologic and orthopaedic disorders, age matching that of the study group, birth at gestational age after 36 and before 42 weeks.
The children’s parents gave their written informed consent to their children’ participation in the study.
All the measurements were performed on the same day, starting with anthropometric measurements. Body height was measured with Seca 213 mobile stadiometer, with an accuracy of 0.1 cm. Body mass was measured using electronic scale OMRON BF 500, with an accuracy of 0.1 kg. The measurements were performed in standard conditions; children in underwear and barefoot, were standing in upright position, without bending knees. In case of all children, a basic anthropometric measures were performed and BMI was calculated.
Assessment of morphotic parameters was performed with the use of the CellDyn 1700 device (Abbott Laboratories. USA) and vitamin D3 levels in serum was performed with the use of the VIDAS® 25-OH Vitamin D Total (bioMerieux, France). The VIDAS® 25-OH Vitamin D Total assay is therefore considered suitable for assessment of vitamin D status in clinical routine.
Blood tests were performed by a nurse with 10 years of professional experience in this field.
Each participant was examined only once. The approximate duration of involvement per participant, approximately 10 minutes.
Intervention code [1] 312941 0
Early Detection / Screening
Comparator / control treatment
The comparator group - children birth at gestational age after 36 and before 42 weeks, without neurologic and orthopaedic disorders, born in 2011
Control group
Active

Outcomes
Primary outcome [1] 308156 0
Assessment of morphotic parameters -
WBC - White Blood Cell, RBC - Red Blood Cell; HGB - Haemoglobin, MVC - mean corpuscular volume; MCH - Mean Corpuscular Hemoglobin; MCHC - Mean Corpuscular Hemoglobin Concentration; MCV - Mean Corpuscular Volume; MPV - Mean Platelet Volume; PLT – Platelets;
use of the CellDyn 1700 device (Abbott Laboratories. USA)
This is a composite secondary outcome.
Timepoint [1] 308156 0
Baseline
Primary outcome [2] 308228 0
Vitamin D3 levels in serum was performed with the use of the VIDAS® 25-OH Vitamin D Total (bioMerieux, France).
Timepoint [2] 308228 0
Baseline
Secondary outcome [1] 354101 0
Anthropometric measurements
Body height - using mobile stadiometer Seca 213, with an accuracy of 0.1 cm.
Timepoint [1] 354101 0
Baseline
Secondary outcome [2] 354306 0
Body mass - using electronic scale OMRON BF 500 with an accuracy of 0.1 kg
Timepoint [2] 354306 0
Baseline

Eligibility
Key inclusion criteria
The following criteria for including into the study group were adopted: guardians’ and children’s consent for participation, birth before gestational age of 32 weeks, lack of neurologic and orthopaedic disorders. Inclusion criteria for the controls were as follows: guardians’ and children’s consent for participation, lack of neurologic and orthopaedic disorders, age matching that of the study group, birth at gestational age after 36 and before 42 weeks
Minimum age
6 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
neurologic and orthopaedic disorders (autism, spina bifida, cerebral palsy)

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
analysis
We conducted statistical analysis of the collected data with the use of the Statistica 13.5 (Stat Soft, Poland). A preliminary power analysis was used to estimate a proper sample size with 0.95 % power, a=0.05, and expected effect size=0.50. The required sample would be 36 preterm children for the city of Rzeszów. To analyse the variables, we used both parametric and nonparametric tests. The choice of a parametric test was conditioned by meeting its basic assumptions, i.e. whether the distribution of the studied variables was in accordance with the normal distribution. This was verified with the Shapiro-Wilk test. For all numerical data, we calculated its descriptive statistics: the mean, the median and the standard deviation. We used the Student t-test for independent variables to assess the differences in the mean value of the numerical features in the two groups studied, or, alternatively, we used the nonparametric Mann-Whitney U test. Statistical significance was assumed at p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2017
Date of last participant enrolment
Anticipated
Actual
31/05/2017
Date of last data collection
Anticipated
Actual
31/05/2017
Sample size
Target
320
Accrual to date
Final
105
Recruitment outside Australia
Country [1] 21048 0
Poland
State/province [1] 21048 0
Podkarpackie, Rzeszów

Funding & Sponsors
Funding source category [1] 301208 0
University
Name [1] 301208 0
University of Rzeszow, Medical Faculty, Institute of Physiotherapy
Country [1] 301208 0
Poland
Primary sponsor type
University
Name
University of Rzeszow, Medical Faculty, Institute of Physiotherapy
Address
ul. Rejtana 16c, Rzeszów 35-959, Poland
Country
Poland
Secondary sponsor category [1] 300840 0
University
Name [1] 300840 0
Centre for Innovative Research in Medical and Natural Sciences, Medical Faculty, University of Rzeszow
Address [1] 300840 0
ul. Warzywna 1a, Rzeszów 35-310, Poland
Country [1] 300840 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301954 0
Bioethics Commission of the University of Rzeszów
Ethics committee address [1] 301954 0
Ethics committee country [1] 301954 0
Poland
Date submitted for ethics approval [1] 301954 0
16/11/2016
Approval date [1] 301954 0
09/02/2017
Ethics approval number [1] 301954 0
Nr 6/2/2017

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88654 0
Dr Walicka-Cuorys Katarzyna
Address 88654 0
Uniwersytet Rzeszowski, Wydzial Medyczny, Rejtana 16 C Rzeszów 35-959
Country 88654 0
Poland
Phone 88654 0
48 502636006
Fax 88654 0
Email 88654 0
[email protected]
Contact person for public queries
Name 88655 0
Katarzyna Walicka-Cuprys
Address 88655 0
Uniwersytet Rzeszowski, Wydzial Medyczny, Rejtana 16 C Rzeszów 35-959
Country 88655 0
Poland
Phone 88655 0
48 502636006
Fax 88655 0
Email 88655 0
[email protected]
Contact person for scientific queries
Name 88656 0
Katarzyna Walicka-Cuprys
Address 88656 0
Uniwersytet Rzeszowski, Wydzial Medyczny, Rejtana 16 C Rzeszów 35-959
Country 88656 0
Poland
Phone 88656 0
48 502636006
Fax 88656 0
Email 88656 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluation of vitamin D3 levels and morphotic parameters of blood in prematurely born children at six years of age.2019https://dx.doi.org/10.1038/s41598-019-51613-y
N.B. These documents automatically identified may not have been verified by the study sponsor.