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Creatine Supplementation in Chronic Fatigue Syndrome

The Effects of Medium-term Creatine Supplementation in Adults With Chronic Fatigue Syndrome

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02374112
Acronym
CREFAS
Enrollment
60
Registered
2015-02-27
Start date
2016-01-31
Completion date
2025-12-31
Last updated
2025-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Fatigue Syndrome

Brief summary

This study evaluates the effectiveness of medium-term supplementation with creatine to improve clinical outcomes in well-defined adult CFS population. Half of the participants will receive creatine while the other half will receive placebo.

Detailed description

Chronic fatigue syndrome (CFS) is a debilitating and complex condition characterized by profound fatigue of unknown cause, which is permanent and limits the person's functional capacity, producing various degrees of disability. It seems that inadequate or impaired energy provision through cellular metabolism may contribute to the pathogenic initiation and maintenance of CFS. A variety of dietary interventions have been used in the management of CFS, yet no therapeutic modality demonstrated overall positive results in terms of effectiveness. Previous studies have evaluated the effects of essential fatty acids, vitamins, minerals and/or enzymes, with findings that do not support the use of a broad-spectrum nutritional supplement in treating CFS-related symptoms. Considering the fact that patients with CFS have lower levels of high-energy compounds (e.g. phosphocreatine, adenosine triphosphate), effective dietary treatment of CFS should be focused on providing compounds that facilitates cellular bioenergetics. Besides other candidate agents, creatine (Cr) could be of particular interest since it occurs naturally in the human body. Placebo-controlled, randomized, double-blind, cross-over clinical trial examining the effectiveness of Cr for the treatment of CFS will be organized according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.

Interventions

DIETARY_SUPPLEMENTCreatine

Creatine supplementation

OTHERPlacebo

Placebo supplementation

Sponsors

Center for Health Sciences, Serbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Intervention model description

Creatine

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* older than 18 years * fulfilled CDC criteria for CFS

Exclusion criteria

* psychiatric co-morbidity * use of dietary supplement within 4-weeks prior to the study commencing * pregnancy

Design outcomes

Primary

MeasureTime frame
Multidimensional Fatigue Inventory (MFI) score3 months

Secondary

MeasureTime frame
health-related quality of life3 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026