Exploring the Therapeutic Effects of Creatine Supplementa... | NCT06992414

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

NCT06992414

Sponsor

University of Calgary

Status

Not yet recruiting

Last Update Posted

May 31, 2025Actual

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Long COVID Fatigue

Interventions

Creatine monohydrate

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2, 2025Estimated

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Oct 31, 2026Estimated

First Submitted Date

May 26, 2025

First Submission Date that Met QC Criteria

May 26, 2025

First Posted Date

May 28, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2025

Last Update Posted Date

May 31, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Keely Shaw, Postdoctoral Associate, University of CalgaryPrincipal Investigator

Lead Sponsor

University of CalgaryOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Creatine monohydrate	Experimental	8 g/day creatine monohydrate	Dietary Supplement: Creatine monohydrate
Maltodextrin	Placebo Comparator	8 g/day maltodextrin	Dietary Supplement: Creatine monohydrate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Creatine monohydrate	Dietary Supplement	8 g/day creatine monohydrate powder	Creatine monohydrate Maltodextrin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oxygen consumption at ventilatory threshold	point of respiratory compensation point (i.e., ventilatory threshold 2) as a percent of maximal oxygen consumption	From enrollment to the end of intervention at 8 weeks
Heart rate at ventilatory threshold	heart rate (in bpm) at point of ventilatory threshold	From enrollment to the end of intervention at 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Fatigue	severity assessed using visual analog scale with zero being not present and 100 being the worst imaginable	From baseline to mid intervention (4 weeks) to the end of the intervention (8 weeks)
Brain fog

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Keely A Shaw, PhD	Contact	3064587102		keely.shaw@ucalgary.ca

Overall Officials

Name	Affiliation	Role
Keely A Shaw, PhD	University of Calgary	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

IPD will be provided upon reasonable request to the PI

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

IPD will be available beginning ~ December 2026 for 5 years

Access Criteria

IPD will be accessible by reasonable request (email) to the PI

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009043	Motor Activity

Ancestor Terms

ID	Term
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003401	Creatine

Ancestor Terms

ID	Term
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals
D000596	Amino Acids

Browse Leaves

Not provided

Browse Branches

Not provided