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Active, Not Recruiting

NCT Number: NCT02374112

Creatine Supplementation in Chronic Fatigue Syndrome

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Creatine

Dietary Supplement

Creatine supplementation

Placebo

Other

Placebo supplementation

Primary outcomes

  1. Multidimensional Fatigue Inventory (MFI) score

    Time frame: 3 months

Secondary outcomes

  1. health-related quality of life

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Center for Health Sciences, Serbia

Other

Registry information

Official study title

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

Acronym: CREFAS

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2015
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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