Effect of Melatonin Plus Zinc Supplementation on Fatigue, Pain, Sleep Disturbances, Anxiety and Depression, and Autonomic Dysfunction in ME/CFS: a Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Self-reported fatigue as assessed by the 40-item Fatigue Impact Scale (FIS-40) over the baseline in the study participants.
研究概览
简要总结
The aim of the study is to investigate the effects of oral melatonin and zinc supplementation on core features in individuals with ME/CFS
详细描述
Myalgic Encephalomyelitis, also known as Chronic Fatigue Syndrome (ME/CFS) is a heterogeneous condition characterized mainly by debilitating and prolonged fatigue, post-exertional malaise (physical, mental and emotional), unrefreshing sleep, cognitive impairment, and orthostatic intolerance with prolonged recovery that is not relieved by rest. Currently, the etiopathogenic mechanisms of ME/CFS are unknown. At present, there is no diagnostic test or effective treatment. MelatoZinc is a food supplement composed of melatonin and zinc, which could contribute to the circadian rhythm homeostasis and regulation of redox imbalance and immune response.
The aim is to evaluate the efficacy and safety of oral treatment with MelatoZinc on the symptomatic complex of fatigue in a larger Spanish ME/CFS population.
This is a single-center, randomized, double-blind, placebo controlled clinical trial. It will include a total of 106 ME/CFS patients who met 2011 ICC criteria for ME/CFS. All patients will take one capsule daily for 16 weeks. Group A will receive MelatoZinc (1 mg melatonin plus 10 mg zinc), and group B will receive a placebo (excipients: isomaltose and magnesium stearate). Clinical symptoms will be evaluated, and standardized questionnaires will be applied to assess the impact of fatigue, pain, anxiety-depression symptoms, sleep quality, dysautonomia, and quality of life. Heart rate variability (HRV) and orthostatic intolerance (10-min NASA Lean Test) will be performed to evaluate autonomic dysfunction. Sleep efficiency will be estimated through an actigraph sensor
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 65 years of age.
- •Patients with ME/CFS who met the diagnostic criteria (2011 ICC criteria) from the Central Sensitization Syndrome Unit (USSC) at the Vall d'Hebron University Hospital.
- •Patients who freely give written consent.
排除标准
- •Any active medical condition that explained chronic fatigue (untreated hypothyroidism, sleep apnea, narcolepsy, medication side-effects).
- •Previous diagnosis not unequivocally resolved (chronic hepatitis, malignancy).
- •Past or current psychiatric disorders (major depressive disorder with psychotic or melancholic features, bipolar disorder, schizophrenia, delusional disorder, dementias, anorexia nervosa, bulimia nervosa).
- •Participation in another clinical trial of the same or different nature in the 30 days prior to study inclusion.
- •In the judgment of the investigator, inability to follow the instructions or to complete the treatment satisfactorily.
- •Failure to provide signed informed consent.
- •Current consumption of medications that may interfere with the results and/or whose withdrawal may be a relevant problem.
- •Anticoagulant treatment.
- •Pregnancy or breast-feeding, or had not used oral contraceptives or other hormonal preparations in the previous 6 months.
- •Smoking, alcohol intake or substance abuse.
- •Severe obesity (class 3 BMI ≥ 40 kg/m2).
- •Hypersensitivity to melatonin and/or zinc dietary supplements.
结局指标
主要结局
Self-reported fatigue as assessed by the 40-item Fatigue Impact Scale (FIS-40) over the baseline in the study participants.
时间窗: During 4 months of treatment and 8 weeks after discontinuation of dietary therapy
The FIS-40 includes three subscales of the perceived impact of fatigue: cognitive (10 items), physical (10 items) and psychosocial functions (20 items), each item being scored from 0 (no fatigue) to 4 (severe fatigue). The total score is calculated by adding together the responses from the 40 questions (range 0-160). Higher scores indicate more functional limitations due to fatigue.
次要结局
- The health-related quality of life (HRQoL) as assessed by the Short-Form 36-Item Health Survey (SF-36) over the baseline in the study participants.(During 4 months of treatment and 8 weeks after discontinuation of dietary therapy)
- Number of awakenings as assessed by an actigraph sensor over the baseline in the study participants.(During 4 months of treatment and 8 weeks after discontinuation of dietary therapy)
- Heart rate variability (HRV) as recorded by the FitLab software over the baseline in the study participants.(During 4 months of treatment and 8 weeks after discontinuation of dietary therapy)
- Orthostatic intolerance as assessed by the active standing test (10-minute NASA Lean test) over the baseline in the study participants.(During 4 months of treatment and 8 weeks after discontinuation of dietary therapy)
- Pain intensity as assessed by a visual analog scale (VAS) over the baseline in the study participants.(During 4 months of treatment and 8 weeks after discontinuation of dietary therapy)
- Anxiety and depression symptoms as assessed by the Hospital Anxiety and Depression Scale (HADS) over the baseline in the study participants.(During 4 months of treatment and 8 weeks after discontinuation of dietary therapy)
- Sleep disturbances as assessed by the Pittsburgh Sleep Quality Index (PSQI) questionnaire over the baseline in the study participants.(During 4 months of treatment and 8 weeks after discontinuation of dietary therapy)
- Sleepiness as assessed by the Epworth Sleepiness Scale (ESS) over the baseline in the study participants.(During 4 months of treatment and 8 weeks after discontinuation of dietary therapy)
- Sleep latency as assessed by an actigraph sensor over the baseline in the study participants.(During 4 months of treatment and 8 weeks after discontinuation of dietary therapy)
- Sleep onset as assessed by an actigraph sensor over the baseline in the study participants(During 4 months of treatment and 8 weeks after discontinuation of dietary therapy)
- Side effect of treatment(During 4 months of treatment and 8 weeks after discontinuation of dietary therapy)
- Sleep efficiency as assessed by an actigraph sensor over the baseline in the study participants.(During 4 months of treatment and 8 weeks after discontinuation of dietary therapy)
- Total sleep time as assessed by an actigraph sensor over the baseline in the study participants.(During 4 months of treatment and 8 weeks after discontinuation of dietary therapy)
- Wake time as assessed by an actigraph sensor over the baseline in the study participants.(During 4 months of treatment and 8 weeks after discontinuation of dietary therapy)