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Trial registered on ANZCTR
Registration number
ACTRN12621000185864
Ethics application status
Approved
Date submitted
22/11/2019
Date registered
22/02/2021
Date last updated
22/02/2021
Date data sharing statement initially provided
22/02/2021
Date results information initially provided
22/02/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
Health benefits of Vitamin C supplementation during health training on physical fitness, body composition and genes expression in elderly women
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Scientific title
The influence of health training on physical fitness and the expression of genes encoding selected proteins associated with the iron metabolism
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Secondary ID [1]
298283
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None
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Universal Trial Number (UTN)
U1111-1234-1307
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
oxidative stress
312973
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avitaminose
312974
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iron metabolism
315298
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Condition category
Condition code
Metabolic and Endocrine
311481
311481
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0
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Normal metabolism and endocrine development and function
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Blood
314314
314314
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0
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Normal development and function of platelets and erythrocytes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
In this study the effect of health training (2x 6-week periods, three times per week for 60 minutes in duration) and suplementation vitamin C in dose 1000 mg/day will be investigation. Vitamin C will be administered in tablets. All participant will keep a supplementation diary. Physical effort and antioxidant supplementation may influence on training adaptation. Vitamin C is well known as antioxidative Vitamin and through reduction in oxidative stress can influence on genes expression, especially easy induce by exercise.
Our study will be involve 15 elderly women (a mean age of 69.2 ± 6.5 years ) randomly chosen to a cross-over study. Women will be randomly divide into two groups. At first 6-week period of health training 7 of them will be supplemented Vit. C while 8 of them will receive a placebo (fiber tablets). In the second 6 week 8 of them (earlier received placebo) will be supplemented and trained while 7 of them will receive fiber in tabs. The wash out period (the break in sessions will last a week). Each volunteer will be qualified by a physician before participation in the study.
The health training will be supervised by the members of our research team. consisting of water gymnastics, gyrokinesis, stabilization training, and Nordic walking at moderate intensity. The type of exercise will be planned in advance for the entire period so that the individual classes are equally distributed. The trainer will additionally record the implementation of the training plan. The training will be conducted for all participants simultaneously, in one group of 15 people. During training, participants maintained their heart rate (Polar H1) at less than 130/min. During whole experiment participants will sign session attendance checklists. All of the tests will be performer in Medical University in Gdansk (genes expression analysis) and University of Physical Education in Kraków (biochemical analysis and level of Vitamin C in serum).
Before and after the first and last interventions period (first and second 6 weeks intervention) measurements of anthropometric indices, body composition are performed. Venous blood is collected from the volunteers four Times: before the start of the experiment, after 6 weeks, before start second 6 week period and at the end of experiment. Vitamin C analysis will be performer immediately after collection, for biochemical analysis serum or plasma will be separate and stored in -80oC, for genetic research lysed leukocytes will be stored in -20oC for further analysis.
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Intervention code [1]
316149
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Prevention
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Intervention code [2]
316693
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Diagnosis / Prognosis
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Comparator / control treatment
A group receiving fiber supplementation in a dose: one 5mg tablet consumed orally once daily for 6 weeks
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Control group
Active
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Outcomes
Primary outcome [1]
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The effect of health training and health training supported with Vitamin C supplementation on VO2 max..
Will be assessed using the cycloergometer Ergoline Ergoselect 150p (Jaeger OxyconPro) and a gas analyzer (Jaeger OxyconPro).
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Assessment method [1]
322046
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Timepoint [1]
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before and 24 h after first 6 week of intervention, before and 24 h after second 6 weeks intervention.
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Primary outcome [2]
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The effect of health training on pro-oxidative and anti-oxidative status
The effect of health training supported with Vitamin C supplementation on Ton pro-oxidative and anti-oxidative status. Composite outcome.
Will be assessed using ELISA KIT (PerOx assay kit Immundiagnostik AG, Germany and ImAnOx assay kit (Immundiagnostik AG, Germany). All analysis will be performed in serum.
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Assessment method [2]
322047
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Timepoint [2]
322047
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Before and 24 h after first six week of intervention, before and 24 h after second 6 week of intervention
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Primary outcome [3]
322048
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Influence of health training supported by supplementation on FTH mRNA.
FTH mRNA assessed using qRT-PCR. RNA will be isolate from peripheral blood leukocytes
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Assessment method [3]
322048
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Timepoint [3]
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One hour before and 24 h after first six weeks intervention and one hour before and 24 h after second six weeks intervention.
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Secondary outcome [1]
377141
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Analysis of meal size estimated using the Album of Photograph Dishes and Products (Jarosz, 2017),
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Assessment method [1]
377141
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Timepoint [1]
377141
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24 h after first 6 week intervention
24 h after second 6 week intervention
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Secondary outcome [2]
377142
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Determination of level of Vitamin C in serum. Will be assessed using the method of Fowler et al. (2014).
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Assessment method [2]
377142
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Timepoint [2]
377142
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One hour before and 24 h after first six weeks intervention and one hour before and 24 h after second six weeks intervention.
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Secondary outcome [3]
380425
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Influence on health training supported by supplementation on CAT mRNA.
CAT mRNA assessed using qRT-PCR. RNA will be isolate from peripheral blood leukocytes,
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Assessment method [3]
380425
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Timepoint [3]
380425
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One hour before and 24 h after first six weeks intervention and one hour before and 24 h after second six weeks intervention.
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Secondary outcome [4]
381324
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Analysis of diet in elderly women assessed by questionnaire (the Diet 5.0 software, developed by the Food and Nutrition Institute of the Institute of Nutrition and Food (Warszawa, Poland),
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Assessment method [4]
381324
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Timepoint [4]
381324
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24 h after first 6 week intervention
24 h after second 6 week intervention
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Eligibility
Key inclusion criteria
no chronic disease and no medication, average physical activity (two time per week for 30 min.), lack of supplementation 6 months before experiment
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Minimum age
60
Years
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Maximum age
75
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Lack of consent of a doctor on physical activity, chronic illness, medication and supplements
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteers are randomly assigned to the groups.
numbered containers
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
During first 6 weeks of training 7 women will be supplemented and 8 unsupplemented. During second 6 weeks of training 8 women will be supplemented and 7 unsupplemented. For all results, the presence of a normal distribution will be check with the Shapiro-Wilk’s test. Results before and after each six week training period will be compared with parametric or non-parametric (Wilcoxon) tests.. To evaluate within-person changes, the paired t-test and ANOVA one-way test will be applied. The genetic data relative gene expressions were analyzed using the comparative method of Schmittgen and Livak [2008]. TAll calculations and graphics will be performe using GraphPad Prism 6.0. Differences were considered statistically significant at a level of p=0.05.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
2/09/2019
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Date of last participant enrolment
Anticipated
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Actual
26/06/2020
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Date of last data collection
Anticipated
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Actual
30/09/2020
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Sample size
Target
15
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Accrual to date
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Final
15
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Recruitment outside Australia
Country [1]
22137
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Poland
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State/province [1]
22137
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Pomeranian
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Funding & Sponsors
Funding source category [1]
302825
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Government body
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Name [1]
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Polish Ministry of Science and Higher Education No. NRSA 406754 and 169/BS/KK/2018.
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Address [1]
302825
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ul. Hoza 20 lub ul. Wspólna 1/3
00-529 Warszawa
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Country [1]
302825
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Poland
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Primary sponsor type
University
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Name
University of Physical Education in Krakow
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Address
al. Jana Pawla II 78
31-571 Krakow
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Country
Poland
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Secondary sponsor category [1]
304590
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University
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Name [1]
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Kazimierz Wielki University in Bydgoszcz
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Address [1]
304590
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ul. Jana Karola Chodkiewicza 30
85-064 Bydgoszcz
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Country [1]
304590
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Poland
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Other collaborator category [1]
281056
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University
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Name [1]
281056
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Kazimierz Wielki University in Bydgoszcz
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Address [1]
281056
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ul. Jana Karola Chodkiewicza 30
85-064 Bydgoszcz
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Country [1]
281056
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Poland
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303407
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Bioethics Committee for Clinical Research at the Regional Medical Chamber in Gdansk
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Ethics committee address [1]
303407
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ul. Sniadeckich 33, 80-204 Gdansk
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Ethics committee country [1]
303407
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Poland
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Date submitted for ethics approval [1]
303407
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Approval date [1]
303407
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22/11/2016
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Ethics approval number [1]
303407
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KB-10/16
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Summary
Brief summary
Oxidative stress can affects iron and iron-regulatory protein status. Vitamin C is well know as antioxidant vitamin and can increase antioxidative status and then influence on training adaptation. Due to this vitamin C is often used in sports supplements, but the data on its beneficial effects are conflicting and the findings vary with dose, age and type of training. Genes associated with cellular stress response and iron metabolism are easily induced by oxidative stress. Vitamin C also influences on iron status by increasing its absorption from the gastrointestinal tract. It is also known that decreased iron cellular status enhances vitamin C-induced apoptosis. These data support an association between vitamin C and iron or ferritin concentration. Thus, the aim of this study was to compare the effects of 6 weeks of endurance training without and with vitamin C (1000 mg daily) supplementation on plasma oxidative stress and antioxidant capacity and genes associated with iron metabolism mRNA.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Malgorzata Zychowska
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Address
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Kazimierz Wielki University in Bydgoszcz
ul. Sportowa 2
85-091 Bydgoszcz
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Country
93570
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Poland
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Phone
93570
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+48 881555337
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Fax
93570
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Email
93570
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[email protected]
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Contact person for public queries
Name
93571
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Prof Malgorzata Zychowska
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Address
93571
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Kazimierz Wielki University in Bydgoszcz
ul. Sportowa 2
85-091 Bydgoszcz
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Country
93571
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Poland
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Phone
93571
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+48 881555337
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Fax
93571
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Email
93571
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[email protected]
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Contact person for scientific queries
Name
93572
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Prof Malgorzata Zychowska
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Address
93572
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Kazimierz Wielki University in Bydgoszcz
ul. Sportowa 2
85-091 Bydgoszcz
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Country
93572
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Poland
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Phone
93572
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+48 881555337
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Fax
93572
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Email
93572
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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
No additional documents have been identified.
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