Creatine Supplementation in Chronic Fatigue Syndrome

NCT ID: NCT02374112

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2025-12-31

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.

Conditions

Chronic Fatigue Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental

Creatine supplementation

Group Type: EXPERIMENTAL

Creatine

Intervention Type: DIETARY_SUPPLEMENT

Creatine supplementation

Control

Placebo supplementation

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo supplementation

Interventions

Creatine

Creatine supplementation

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo supplementation

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for Health Sciences, Serbia

OTHER

Sponsor Role: lead

Responsible Party

Prof. Sergej M. Ostojic, MD, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sergej M Ostojic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Health, Exercise and Sport Sciences

References

Vermeulen RC, Kurk RM, Visser FC, Sluiter W, Scholte HR. Patients with chronic fatigue syndrome performed worse than controls in a controlled repeated exercise study despite a normal oxidative phosphorylation capacity. J Transl Med. 2010 Oct 11;8:93. doi: 10.1186/1479-5876-8-93.

Reference Type: BACKGROUND

PMID: 20937116 (View on PubMed)

Hollingsworth KG, Jones DE, Taylor R, Blamire AM, Newton JL. Impaired cardiovascular response to standing in chronic fatigue syndrome. Eur J Clin Invest. 2010 Jul;40(7):608-15. doi: 10.1111/j.1365-2362.2010.02310.x. Epub 2010 May 23.

Reference Type: BACKGROUND

PMID: 20497461 (View on PubMed)

Other Identifiers

15-2103C

Identifier Type: -

Identifier Source: org_study_id