Clinical trial NCT02374112: Creatine Supplementation in Chronic Fatigue Syndrome
Official title: The Effects of Medium-term Creatine Supplementation in Adults With Chronic Fatigue Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Fatigue Syndrome
Lead sponsor: Center for Health Sciences, Serbia
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Creatine
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Multidimensional Fatigue Inventory (MFI) score
timeFrame: 3 months
Secondary outcomes:
measure: health-related quality of life
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Center for Health, Exercise and Sport Sciences
name: Sergej M Ostojic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.