Exploring the Therapeutic Effects of Creatine Supplementation for Long COVID-19

NCT ID: NCT06992414

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-02

Study Completion Date

2026-10-31

Brief Summary

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Individuals living with Long COVID often experiencing a degree of undue fatigue after physical or cognitive exertion secondary to the condition, timed post-exertional malaise 9PEM). This trial aims to explore the efficacy of creatine monohydrate in managing PEM

Detailed Description

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cognitive dysfunction, and post-exertional malaise are common complaints of those living with Post-COVID Condition (PCC), a sequelae of symptoms that persist beyond acute infection. Similar to other types of post-viral fatigue, the diagnosis and treatment of PCC are challenging due to the lack of a valid biomarker for the condition. Though the etiology of PCC is not well understood, recent research has found reduced skeletal muscle creatine concentration in those with PCC, which may contribute to fatigue. The objective of this study is to determine if eight weeks of creatine monohydrate supplementation (8g/day) improves symptoms of fatigue, cognition, exercise capacity, and PEM in individuals living with PCC.

Participants will complete two cardiopulmonary exercise tests 24-hours apart on a cycle ergometer before and after an eight-week intervention period. Venous blood samples will be collected before and after exercise on both days to assess changes in mitochondrial function. During the intervention, participants will be randomly assigned to supplement with 8g/day of either creatine monohydrate or a control (maltodextrin). Cognition will be indirectly assessed via self-report of cognitive symptom frequency and severity at baseline, mid-intervention (i.e., 4 weeks) and post-intervention.

Conditions

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Long COVID Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized 1:1 to the treatment or control group
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Creatine monohydrate

8 g/day creatine monohydrate

Group Type EXPERIMENTAL

Creatine monohydrate

Intervention Type DIETARY_SUPPLEMENT

8 g/day creatine monohydrate powder

Maltodextrin

8 g/day maltodextrin

Group Type PLACEBO_COMPARATOR

Creatine monohydrate

Intervention Type DIETARY_SUPPLEMENT

8 g/day creatine monohydrate powder

Interventions

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Creatine monohydrate

8 g/day creatine monohydrate powder

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Experiencing symptoms at least 3 months after a COVID-19 diagnosis confirmed by positive polymerase chain reaction (PCR) test
* Experiencing post-exertional malaise, as per the DePaul Symptom Questionnaire

Exclusion Criteria

* Allergy or intolerance to creatine monohydrate or maltodextrin
* Supplemented with creatine in the past eight weeks
* orthopaedic injury or condition that would prevent exercise testing
* change in medication related to Long COVID symptom management in the past month.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Keely Shaw

Postdoctoral Associate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keely A Shaw, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Central Contacts

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Keely A Shaw, PhD

Role: CONTACT

3064587102

Other Identifiers

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REB25-0930

Identifier Type: -

Identifier Source: org_study_id

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