The Effect of Creatine Monohydrate on Persistent Post-concussive Symptoms

ConditionsMild Traumatic Brain Injury Concussion, Brain

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age20-45

SponsorPsychiatric Research Unit, Region Zealand, Denmark

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

=<6 months

=>18 months

Trial design

Design model

Parallel

Treatments tested in this trial

Creatine Monohydrate
Dietary supplement
Follows

Treatment groups

45 Participants

are divided into 3 treatment groups

Group A: Intervention groupExperimental treatment 1 intervention

Group B: Control groupNo intervention 0 interventions

Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Change from Baseline Post-Concussion Symptoms at 7 weeks

Rivermead Post-Concussion Symptom Questionnaire

Time frame

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

Secondary outcomes

Change from Baseline Body weight at 7 weeks

As we are using a dietary supplement as our intervention, following participants body weight in kg throughout the intervention is necessary in order to know if changes in body weight have any effect on our results.

Time frame

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

Other outcomes

Height

Descriptive measurement

Time frame

Baseline

Training status

To determine if the participants are at the same initial training status.

Time frame

Baseline

Period with PPCS

To assess persistent post-concussive symptoms

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Psychiatric Research Unit, Region Zealand, Denmark

Lead sponsor

University of Southern Denmark

Collaborator

Source ClinicalTrials.gov

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