The Effect of Creatine Monohydrate on Persistent Post-concussive Symptoms - a Pilot Study Protocol
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 45
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Denmark
University of Southern Denmark
RECRUITING
Odense
Contact Information
Primary
Ronni Lykke Bødker, MSc
ronni@commotio.dk
+45 61710188
Backup
Michael Marcussen, Dr.
mhmarcussen@health.sdu.dk
+4526369503
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 45
Treatments
Experimental: Intervention group
Creatine monohydrate administered once a day for seven weeks - with 5 g/day for the entire period.
No_intervention: Control group
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_comparator: Placebo
Powdered Sugar administered once a day for seven weeks - with 5g/day for the entire period.
Related Therapeutic Areas
Sponsors
Collaborators: University of Southern Denmark
Leads: Psychiatric Research Unit, Region Zealand, Denmark