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

U

University of Calgary

Status

Begins enrollment this month

Conditions

Long COVID Fatigue

Treatments

Dietary Supplement: Creatine monohydrate

Study type

Interventional

Funder types

Other

Identifiers

NCT06992414
REB25-0930

Details and patient eligibility

About

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

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

24 participants in 2 patient groups, including a placebo group

Creatine monohydrate
Experimental group
Description:
8 g/day creatine monohydrate
Treatment:
Dietary Supplement: Creatine monohydrate
Maltodextrin
Placebo Comparator group
Description:
8 g/day maltodextrin
Treatment:
Dietary Supplement: Creatine monohydrate

Trial contacts and locations

0

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Central trial contact

Keely A Shaw, PhD

Data sourced from clinicaltrials.gov

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