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

NCT06992414 | Not Yet Recruiting

• 1 other identifier: REB25-0930
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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

Conditions

Long COVID Fatigue

Keywords

creatine; post-exertional malaise; exercise; nutraceutical

Outcome Measures

Primary Outcomes (2)

• 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 (2)

• Fatigue

  From baseline to mid intervention (4 weeks) to the end of the intervention (8 weeks)

• Brain fog

  From baseline to mid intervention (4 weeks) to post intervention (8 weeks)

Study Arms (2)

Creatine monohydrate

EXPERIMENTAL

8 g/day creatine monohydrate

Dietary Supplement: Creatine monohydrate

Maltodextrin

PLACEBO COMPARATOR

8 g/day maltodextrin

Dietary Supplement: Creatine monohydrate

Interventions

Creatine monohydrate DIETARY_SUPPLEMENT

8 g/day creatine monohydrate powder

Creatine monohydrate; Maltodextrin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead

MeSH Terms

Conditions

Motor Activity

Interventions

Creatine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Keely A Shaw, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keely A Shaw, PhD

CONTACT

3064587102; keely.shaw@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Associate

Model Details: Participants will be randomized 1:1 to the treatment or control group

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: May 28, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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