Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT02374112
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-23
First Post:
2015-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Creatine Supplementation in Chronic Fatigue Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003401', 'term': 'Creatine'}], 'ancestors': [{'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Creatine'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2015-02-22', 'studyFirstSubmitQcDate': '2015-02-25', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Multidimensional Fatigue Inventory (MFI) score', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'health-related quality of life', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Fatigue Syndrome']}, 'referencesModule': {'references': [{'pmid': '20937116', 'type': 'BACKGROUND', '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.'}, {'pmid': '20497461', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nA 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.\n\nPlacebo-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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 18 years\n* fulfilled CDC criteria for CFS\n\nExclusion Criteria:\n\n* psychiatric co-morbidity\n* use of dietary supplement within 4-weeks prior to the study commencing\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02374112', 'acronym': 'CREFAS', 'briefTitle': 'Creatine Supplementation in Chronic Fatigue Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Center for Health Sciences, Serbia'}, 'officialTitle': 'The Effects of Medium-term Creatine Supplementation in Adults With Chronic Fatigue Syndrome', 'orgStudyIdInfo': {'id': '15-2103C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Creatine supplementation', 'interventionNames': ['Dietary Supplement: Creatine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Placebo supplementation', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Creatine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Creatine supplementation', 'armGroupLabels': ['Experimental']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo supplementation', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sergej M Ostojic, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Health, Exercise and Sport Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Health Sciences, Serbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Prof. Sergej M. Ostojic, MD, PhD', 'investigatorAffiliation': 'Center for Health Sciences, Serbia'}}}}