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.|
|ClinicalTrials.gov Identifier: NCT02374112|
Recruitment Status : Active, not recruiting
First Posted : February 27, 2015
Last Update Posted : January 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Fatigue Syndrome||Dietary Supplement: Creatine Other: Placebo||Phase 2|
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|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Creatine|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||The Effects of Medium-term Creatine Supplementation in Adults With Chronic Fatigue Syndrome|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Dietary Supplement: Creatine
Placebo Comparator: Control
- Multidimensional Fatigue Inventory (MFI) score [ Time Frame: 3 months ]
- health-related quality of life [ Time Frame: 3 months ]
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
|Principal Investigator:||Sergej M Ostojic, MD, PhD||Center for Health, Exercise and Sport Sciences|