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Trial record 10 of 112 for:    Chronic Fatigue Syndrome

Creatine Supplementation in Chronic Fatigue Syndrome (CREFAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02374112
Recruitment Status : Active, not recruiting
First Posted : February 27, 2015
Last Update Posted : July 23, 2019
Information provided by (Responsible Party):
Assoc. Prof. Sergej M. Ostojic, MD, PhD, Center for Health, Exercise and Sport Sciences, Serbia

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.

Condition or disease Intervention/treatment Phase
Chronic Fatigue Syndrome Dietary Supplement: Creatine Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Creatine
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Effects of Medium-term Creatine Supplementation in Adults With Chronic Fatigue Syndrome
Study Start Date : January 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Experimental
Creatine supplementation
Dietary Supplement: Creatine
Creatine supplementation

Placebo Comparator: Control
Placebo supplementation
Other: Placebo
Placebo supplementation

Primary Outcome Measures :
  1. Multidimensional Fatigue Inventory (MFI) score [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. health-related quality of life [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02374112

Sponsors and Collaborators
Center for Health, Exercise and Sport Sciences, Serbia
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Principal Investigator: Sergej M Ostojic, MD, PhD Center for Health, Exercise and Sport Sciences

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Responsible Party: Assoc. Prof. Sergej M. Ostojic, MD, PhD, Professor, Center for Health, Exercise and Sport Sciences, Serbia Identifier: NCT02374112     History of Changes
Other Study ID Numbers: 15-2103C
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases