NCT02374112

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.

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

9.9 years

First QC Date

February 22, 2015

Last Update Submit

May 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Multidimensional Fatigue Inventory (MFI) score

    3 months

Secondary Outcomes (1)

  • health-related quality of life

    3 months

Study Arms (2)

Experimental

EXPERIMENTAL

Creatine supplementation

Dietary Supplement: Creatine

Control

PLACEBO COMPARATOR

Placebo supplementation

Other: Placebo

Interventions

CreatineDIETARY_SUPPLEMENT

Creatine supplementation

Experimental
PlaceboOTHER

Placebo supplementation

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • older than 18 years
  • fulfilled CDC criteria for CFS

You may not qualify if:

  • psychiatric co-morbidity
  • use of dietary supplement within 4-weeks prior to the study commencing
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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: 20937116BACKGROUND
  • 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.

    PMID: 20497461BACKGROUND

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Creatine

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Sergej M Ostojic, MD, PhD

    Center for Health, Exercise and Sport Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Creatine
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 22, 2015

First Posted

February 27, 2015

Study Start

January 1, 2016

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 23, 2025

Record last verified: 2025-05