The Effect of Creatine Monohydrate on Persistent Post-concussive Symptoms

NCT05562232 | Recruiting

• 1 other identifier: PRURegionZealand4
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study, is to investigate whether creatine monohydrate as a supplement reduces the number and severity of symptoms in patients with persistent post-concussive symptoms through self-reported post-concussion symptoms questionnaires.

Conditions

Mild Traumatic Brain Injury; Concussion, Brain

Keywords

Concussion; Mild traumatic brain injury; Creatine monohydrate; Persistent post-concussive symptoms

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Post-Concussion Symptoms at 7 weeks

  Rivermead Post-Concussion Symptom Questionnaire

  Baseline, 3 weeks and 7 weeks (follow-up)

Secondary Outcomes (1)

• Change from Baseline Body weight at 7 weeks

  Baseline, 3 weeks and 7 weeks (follow-up)

Other Outcomes (3)

• Height

  Baseline

• Training status

  Baseline

• Period with PPCS

  Baseline

Study Arms (3)

Intervention group

EXPERIMENTAL

Creatine monohydrate administered once a day for seven weeks - with 5 g/day for the entire period.

Dietary Supplement: Creatine Monohydrate

Control group

NO INTERVENTION

The control group will receive standard care. However, to our knowledge there is no common accepted description of a standard care in the literature. In general, these participants will be advised to keep themselves as asymptomatic as possible throughout the entire seven weeks, and besides that live as normal a life as they can.

Placebo

PLACEBO COMPARATOR

Powdered Sugar administered once a day for seven weeks - with 5g/day for the entire period.

Dietary Supplement: Creatine Monohydrate

Interventions

Creatine Monohydrate DIETARY_SUPPLEMENT

Follows

Intervention group; Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Have had PPCS for a minimum of six months and a maximum of 18 months at the start of the study.
• Being between 20 and 45 years of age

You may not qualify if:

• Elite athletes, as well as people who in general is physical active, at an intensity of moderat to high, for more than ten hours a week on average.
• Participation in other interventions/treatment that could affect this study
• Have had PPCS in:
• =\<6 months
• =\>18 months
• Pregnant

Sponsors & Collaborators

• Psychiatric Research Unit, Region Zealand, Denmark: lead
• University of Southern Denmark: collaborator

Study Sites (1)

University of Southern Denmark

Odense, 5239, Denmark

RECRUITING

Related Publications (35)

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MeSH Terms

Conditions

Brain Concussion

Interventions

Creatine

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Michael Marcussen, Dr.

  University of Southern Denmark (SDU), Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronni Lykke Bødker, MSc

CONTACT

+45 61710188; ronni@commotio.dk

Michael Marcussen, Dr.

CONTACT

+4526369503; mhmarcussen@health.sdu.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 30, 2022
• Study Start: August 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

DK (1)