Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001437550p
Ethics application status
Submitted, not yet approved
Date submitted
15/10/2024
Date registered
10/12/2024
Date last updated
10/12/2024
Date data sharing statement initially provided
10/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of creatine supplementation for injury prevention in soccer players
Scientific title
Effects of creatine supplementation in preventing injuries in soccer players: a pilot, randomized controlled trial
Secondary ID [1] 313196 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal Injuries 335489 0
Condition category
Condition code
Musculoskeletal 332048 332048 0 0
Other muscular and skeletal disorders
Injuries and Accidents 332247 332247 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 g / day creatine supplementation (with pills) during 14 weeks, with breakfast.
Intervention code [1] 329771 0
Prevention
Comparator / control treatment
3 g / day placebo (maltodextrin pills) supplementation during 14 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 339652 0
Musculoskeletal injuries
Timepoint [1] 339652 0
4, 5, 6, 7, 8, 9 , 10, 11, 12, 13 and 14 weeks after starting the supplementation
Primary outcome [2] 339653 0
Post- training Fatigue
Timepoint [2] 339653 0
Before intervention and every post-training session during the weeks 4 to 14 after starting the supplementation
Primary outcome [3] 339654 0
Musculoskeletal pain in lower limbs
Timepoint [3] 339654 0
Before the intervention and every post-training session during the weeks 4 to 14 after starting the supplementation
Secondary outcome [1] 440745 0
Maximal isometric strength in lower limbs: knee flexion
Timepoint [1] 440745 0
Baseline and post-intervention (14 weeks)
Secondary outcome [2] 440746 0
Vertical jump, in cm
Timepoint [2] 440746 0
Baseline and post-intervention (14 weeks)
Secondary outcome [3] 440747 0
Internal training load
Timepoint [3] 440747 0
Every post-training session during the week 4,5,6,7,8,9,10,11,12,13 and 14
Secondary outcome [4] 440748 0
Knee flexion range of motion
Timepoint [4] 440748 0
Baseline and 14 weeks after starting the intervention
Secondary outcome [5] 441522 0
Knee extension range of motion
Timepoint [5] 441522 0
Baseline and 14 weeks after starting the intervention
Secondary outcome [6] 441523 0
Maximal isometric strength in lower limbs: knee extension
Timepoint [6] 441523 0
Baseline and post-intervention (14 weeks)
Secondary outcome [7] 441524 0
Maximal isometric strength in lower limbs: hip flexion
Timepoint [7] 441524 0
Baseline and post-intervention (14 weeks)
Secondary outcome [8] 441525 0
Maximal isometric strength in lower limbs: hip extension
Timepoint [8] 441525 0
Baseline and post-intervention (14 weeks)

Eligibility
Key inclusion criteria
Active soccer players in a semi-professional team
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Having lower limbs injuries in the last six months
Already having a creatine supplementation
Allergies to creatine
Nephropathy

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by Microsoft Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/01/2025
Actual
Date of last participant enrolment
Anticipated
20/01/2025
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 26637 0
Spain
State/province [1] 26637 0

Funding & Sponsors
Funding source category [1] 317642 0
Self funded/Unfunded
Name [1] 317642 0
Country [1] 317642 0
Primary sponsor type
Individual
Name
Guillermo García-Pérez-de-Sevilla; Universidad Europea de Madrid
Address
Country
Spain
Secondary sponsor category [1] 319957 0
None
Name [1] 319957 0
Address [1] 319957 0
Country [1] 319957 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316340 0
Universidad Europea de Madrid- Committee for Ethics in Research
Ethics committee address [1] 316340 0
Ethics committee country [1] 316340 0
Spain
Date submitted for ethics approval [1] 316340 0
30/10/2024
Approval date [1] 316340 0
Ethics approval number [1] 316340 0

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

Contacts
Principal investigator
Name 137586 0
Dr Guillermo García-Pérez-de-Sevilla
Address 137586 0
Universidad Europea de Madrid. Calle Tajo s/n 28670 Villaviciosa de Odón (SPAIN)
Country 137586 0
Spain
Phone 137586 0
+34629207357
Fax 137586 0
Email 137586 0
guillermo.garcia@universidadeuropea.es
Contact person for public queries
Name 137587 0
Guillermo García-Pérez-de-Sevilla
Address 137587 0
Universidad Europea de Madrid. Calle Tajo s/n 28670 Villaviciosa de Odón (SPAIN)
Country 137587 0
Spain
Phone 137587 0
+34629207357
Fax 137587 0
Email 137587 0
guillermo.garcia@universidadeuropea.es
Contact person for scientific queries
Name 137588 0
Guillermo García-Pérez-de-Sevilla
Address 137588 0
Universidad Europea de Madrid. Calle Tajo s/n 28670 Villaviciosa de Odón (SPAIN)
Country 137588 0
Spain
Phone 137588 0
+34629207357
Fax 137588 0
Email 137588 0
guillermo.garcia@universidadeuropea.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
No additional documents have been identified.