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Not yet recruiting NCT06992414

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

No phase Interventional Long COVID Fatigue

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Creatine monohydrate.
Who it may be relevant to
Registry conditions: Long COVID Fatigue. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Exploring Creatine Supplementation for Improved Exercise Capacity and Reduced Fatigue in Long COVID-19: A Randomized Controlled Trial

Overview

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.

Interventions

  • Dietary supplement Creatine monohydrate
    8 g/day creatine monohydrate powder

Primary outcome measures

  • Oxygen consumption at ventilatory threshold [Time frame: From enrollment to the end of intervention at 8 weeks]
  • Heart rate at ventilatory threshold [Time frame: From enrollment to the end of intervention at 8 weeks]
Secondary outcome measures (2)
  • Fatigue [Time frame: From baseline to mid intervention (4 weeks) to the end of the intervention (8 weeks)]
  • Brain fog [Time frame: From baseline to mid intervention (4 weeks) to post intervention (8 weeks)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06992414 · REB25-0930

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗