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Trial record 9 of 98 for:    Chronic Fatigue Syndrome

Creatine Supplementation in Chronic Fatigue Syndrome (CREFAS)

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ClinicalTrials.gov Identifier: NCT02374112
Recruitment Status : Active, not recruiting
First Posted : February 27, 2015
Last Update Posted : January 24, 2018
Sponsor:
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 Phase 2

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.


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 2018
Estimated Study Completion Date : December 2018

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
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

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 ClinicalTrials.gov identifier (NCT number): NCT02374112


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

Publications:
Responsible Party: Assoc. Prof. Sergej M. Ostojic, MD, PhD, Professor, Center for Health, Exercise and Sport Sciences, Serbia
ClinicalTrials.gov Identifier: NCT02374112     History of Changes
Other Study ID Numbers: 15-2103C
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Syndrome
Fatigue
Fatigue Syndrome, Chronic
Disease
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases