This trial is active, not recruiting.

Condition chronic fatigue syndrome
Treatments creatine, placebo
Phase phase 2
Sponsor Center for Health, Exercise and Sport Sciences, Serbia
Start date January 2016
End date December 2018
Trial size 60 participants
Trial identifier NCT02374112, 15-2103C


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
Creatine supplementation
Creatine supplementation
(Placebo Comparator)
Placebo supplementation
Placebo supplementation

Primary Outcomes

Multidimensional Fatigue Inventory (MFI) score
time frame: 3 months

Secondary Outcomes

health-related quality of life
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Effects of Medium-term Creatine Supplementation in Adults With Chronic Fatigue Syndrome
Principal investigator Sergej M Ostojic, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Center for Health, Exercise and Sport Sciences, Serbia.