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Creatine Supplementation in Chronic Fatigue Syndrome (CREFAS)

Primary Purpose

Chronic Fatigue Syndrome

Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Creatine
Placebo
Sponsored by
Center for Health, Exercise and Sport Sciences, Serbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Fatigue Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Experimental

    Control

    Arm Description

    Creatine supplementation

    Placebo supplementation

    Outcomes

    Primary Outcome Measures

    Multidimensional Fatigue Inventory (MFI) score

    Secondary Outcome Measures

    health-related quality of life

    Full Information

    First Posted
    February 22, 2015
    Last Updated
    February 6, 2023
    Sponsor
    Center for Health, Exercise and Sport Sciences, Serbia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02374112
    Brief Title
    Creatine Supplementation in Chronic Fatigue Syndrome
    Acronym
    CREFAS
    Official Title
    The Effects of Medium-term Creatine Supplementation in Adults With Chronic Fatigue Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    January 2016 (Actual)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Center for Health, Exercise and Sport Sciences, Serbia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Fatigue Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Creatine
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    Creatine supplementation
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo supplementation
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Creatine
    Intervention Description
    Creatine supplementation
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo supplementation
    Primary Outcome Measure Information:
    Title
    Multidimensional Fatigue Inventory (MFI) score
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    health-related quality of life
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sergej M Ostojic, MD, PhD
    Organizational Affiliation
    Center for Health, Exercise and Sport Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20937116
    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.
    Results Reference
    background
    PubMed Identifier
    20497461
    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.
    Results Reference
    background

    Learn more about this trial

    Creatine Supplementation in Chronic Fatigue Syndrome

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