Creatine Supplementation in Chronic Fatigue Syndrome

Chronic Fatigue Syndrome Clinical Trial

— CREFAS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02374112
• Other study ID #: 15-2103C
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: Center for Health, Exercise and Sport Sciences, Serbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Syndrome

Intervention

Dietary Supplement:
• Creatine
Creatine supplementation

Other:
• Placebo
Placebo supplementation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Center for Health, Exercise and Sport Sciences, Serbia

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multidimensional Fatigue Inventory (MFI) score		3 months
Secondary	health-related quality of life		3 months