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临床试验/NCT02374112
NCT02374112进行中(未招募)不适用

The Effects of Medium-term Creatine Supplementation in Adults With Chronic Fatigue Syndrome

Center for Health Sciences, Serbia0 个研究点目标入组 60 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
主要终点
Multidimensional Fatigue Inventory (MFI) score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • older than 18 years
  • fulfilled CDC criteria for CFS

排除标准

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

结局指标

主要结局

Multidimensional Fatigue Inventory (MFI) score

时间窗: 3 months

次要结局

  • health-related quality of life(3 months)

研究者

发起方
Center for Health Sciences, Serbia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Sergej M. Ostojic, MD, PhD

Professor

Center for Health Sciences, Serbia

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