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
About this trial
This is an interventional treatment trial for Chronic Fatigue Syndrome
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
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
NCT ID
NCT02374112
First Posted
February 22, 2015
Last Updated
February 6, 2023
Sponsor
Center for Health, Exercise and Sport Sciences, Serbia
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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