Clinical Trial to Assess the Improvement of Fatigue, Sleep Problems, Anxiety / Depression, Neurovegetatives Alterations and Quality of Life After the Administration of ImmunoVita® in Chronic Fatigue Syndrome Patients
Primary Purpose
Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Active
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring Fatigue Syndrome, Encephalomyelitis, Fibromyalgia
Eligibility Criteria
Inclusion Criteria:
- Adult patients of both sexes, between 18-65 years.
- Patients with a BMI ≤ 25.
- Patients diagnosed with Chronic Fatigue Syndrome according to diagnostic criteria of 1994 CDC / Fukuda and 2003 Canadian criteria from the University of Central Sensitization Syndrome (Vall d'Hebron University Hospital, Barcelona).
- Patients who freely grant written consent.
Exclusion Criteria:
- Patients who are participating in another clinical trial of the same or different nature in the last 30 days prior to inclusion.
- Any subject that, in the opinion of the investigator, is not able to follow the instructions or make a good completion of the treatment.
- Subjects who do not grant written informed consent to participate in the study.
- Patients who are receiving any of the prohibited drugs or products and that the withdrawal of the drugs / products not allowed in the study is expected to pose a relevant problem.
- Pregnant women and / or during breastfeeding periods.
- Patients under treatment with oral anticoagulants.
- Patient with any type of immunosuppression.
Sites / Locations
- Hospital Vall d'Hebron
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ImmunoVita®
Placebo
Arm Description
250 mg Yeast beta-glucan + 3.75 microg Vitamin D3 + 1.05 mg Vitamin B6 + 7.5 mg zinc)
473,2 mg microcristalline cellulose + 0,06 mg Brown Oxide dye + 0,27 mg yellow A oxide dye
Outcomes
Primary Outcome Measures
Perception of fatigue (FIS-40).
The Fatigue Impact Scale (FIS-40) is a 40-item questionnaire designed to assess fatigue symptoms as part of an underlying chronic condition. It includes three domains reflecting the perceived feeling of fatigue: physical (10 items), cognitive (10 items) and psychosocial functions (20 items). Each item is scored from 0 (no fatigue) to 4 (severe fatigue). The overall score is calculated by adding together the responses to the 40 questions (ranging from 0 to 160). Higher scores indicate more functional limitations due to fatigue.
Secondary Outcome Measures
Sleep dysfunction (Pittsburg questionnaire)
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-administrated questionnaire commonly used to assess sleep disturbances over a 1-month interval. Scores are acquired on each of seven domains of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each domain is scored from 0 to 3 (0 = no problems and 3 = severe problems). The overall PSQI score ranges from 0 to 21 points, with scores of > 5 indicating poorer sleep quality.
Hospital anxiety-depression scale (HAD)
To assess anxiety and depression symptoms the Hospital Anxiety and Depression Scale (HADS) was used; a validated 14 item self-reported measure (seven items associated with anxiety symptoms and seven with depression) over the last week. Each item is scored on a 4-point Likert scale (e.g., 0 = as much as I always do; 1 = not quite so much; 2 = definitely not so much; and 3 = not at all) giving maximum subscale scores of 21 for depression and anxiety, respectively. Scores of 0-7 are interpreted as normal; scores of 8-10 reflect mild symptoms, 11-14 moderate, and 15-21 severe for either anxiety or depression. The global HADS score ranges from 0 (no anxiety/depression) to 42 (severe anxiety/depression).
Quality of life (SF-36)
The SF-36 questionnaire was used to assess health-related quality of life. This is a 36-item broadly-based self-report survey of physical and mental functioning status related to health. The SF-36 assesses functioning on eight subscales including domains of physical functioning, physical role functioning, bodily pain, general health perception, vitality, social role functioning, emotional role functioning, and mental health. Lower scores indicate a more negative impact of an individual's health on functioning.
Full Information
NCT ID
NCT04301609
First Posted
March 4, 2020
Last Updated
March 13, 2023
Sponsor
Vitae Health Innovation
Collaborators
Hospital Vall d'Hebron
1. Study Identification
Unique Protocol Identification Number
NCT04301609
Brief Title
Clinical Trial to Assess the Improvement of Fatigue, Sleep Problems, Anxiety / Depression, Neurovegetatives Alterations and Quality of Life After the Administration of ImmunoVita® in Chronic Fatigue Syndrome Patients
Official Title
Randomized, Comparative, Double-blind, and Placebo-controlled Clinical Trial to Assess the Improvement of Fatigue, Sleep, Anxiety / Depression, Neurovegetatives Alterations and Quality of Life After the Administration of ImmunoVita® in Chronic Fatigue Syndrome Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 10, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
January 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitae Health Innovation
Collaborators
Hospital Vall d'Hebron
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chronic Fatigue Syndrome, also known as Myalgic Encephalomyelitis (CFS / MS) is a medical entity characterized mainly by debilitating and prolonged fatigue lasting more than 6 months, post-exertion fatigue (physical and / or mental), non-sleep restorative, cognitive impairment and orthostatic intolerance with prolonged recovery that is not relieved by rest. Currently, the etiopathogenic mechanisms of the disease are not known, although mitochondrial dysfunction with bioenergetic immuno-metabolism alterations, oxidative stress, and immuno-inflammatory response stands out. At present, there is no diagnostic test, nor effective treatment in the disease. ImmunoVita, is a food supplement composed of the latest yeast beta-glucans, in addition to vitamin D3, vitamin B6 and zinc, which could contribute to the normal functioning of the immune system and the inflammatory response.
Detailed Description
In patients with CFS / ME, neuroimmune, gastrointestinal, autonomic and cardiovascular alterations have been observed, among others. CFS / ME is characterized by disabling chronic fatigue, non-restorative sleep, severe intolerance to physical exercise, neurocognitive dysfunction with changes in concentration and immediate memory and neurovegetative symptoms in the form of dizziness, syncopes and alterations in bowel and bladder rhythm . Within the etiopathogenic hypotheses of the disease, they are involved if patients treated with ImmunoVita® could significantly reduce the scores on the scale of the impact of fatigue, sleep problems, neurovegetative dysfunction, anxiety / depression, and improve the quality of life compared to the placebo group.
Based on the different etiopathogenic hypotheses of the syndrome, various mechanisms would be involved, which could modulate them, the ImmunoVita food complex.
Do patients with CFS / ME have high scores on the fatigue impact scale, hospital anxiety-depression scale and Pittsburg sleep quality questionnaire?
Do patients with CFS / ME have high scores in the autonomic dysfunction symptomatology scale?
Do patients with CFS / ME have low scores in the SF-36 quality of life questionnaire?
Do CFS / MS patients treated with ImmunoVita significantly reduce the scores on the scales of fatigue, anxiety / depression and autonomic dysfunction?
Will patients with CFS / ME treated with ImmunoVita significantly increase the scores on the SF-36 quality of life questionnaire?
GOALS
Main goal
The objective of this study is to assess the efficacy of active ImmunoVita® in patients with CFS / MS vs. placebo in the perception of fatigue, evaluated through the scale of perception of fatigue (FIS-40).
Secondary goals:
Evaluate the efficacy of active ImmunoVita® in patients with CFS / MS vs. placebo in the improvement of sleep dysfunction, through the Pittsburg questionnaire.
Analyze the efficacy of active ImmunoVita®, in patients with CFS / ME vs. placebo in the improvement of anxiety-depressive symptomatology, through the hospital anxiety-depression scale (HAD).
Evaluate the efficacy of active ImmunoVita®, in patients with CFS / ME vs. placebo in the improvement of the quality of life, through the SF-36 questionnaire.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
Keywords
Fatigue Syndrome, Encephalomyelitis, Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ImmunoVita®
Arm Type
Active Comparator
Arm Description
250 mg Yeast beta-glucan + 3.75 microg Vitamin D3 + 1.05 mg Vitamin B6 + 7.5 mg zinc)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
473,2 mg microcristalline cellulose + 0,06 mg Brown Oxide dye + 0,27 mg yellow A oxide dye
Intervention Type
Dietary Supplement
Intervention Name(s)
Active
Other Intervention Name(s)
ImmunoVita®
Intervention Description
Take 4 capsules daily (2 capsules on an empty stomach + 2 capsules 30 minutes before dinner).
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Take 4 capsules daily (2 capsules on an empty stomach + 2 capsules 30 minutes before dinner).
Primary Outcome Measure Information:
Title
Perception of fatigue (FIS-40).
Description
The Fatigue Impact Scale (FIS-40) is a 40-item questionnaire designed to assess fatigue symptoms as part of an underlying chronic condition. It includes three domains reflecting the perceived feeling of fatigue: physical (10 items), cognitive (10 items) and psychosocial functions (20 items). Each item is scored from 0 (no fatigue) to 4 (severe fatigue). The overall score is calculated by adding together the responses to the 40 questions (ranging from 0 to 160). Higher scores indicate more functional limitations due to fatigue.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Sleep dysfunction (Pittsburg questionnaire)
Description
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-administrated questionnaire commonly used to assess sleep disturbances over a 1-month interval. Scores are acquired on each of seven domains of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each domain is scored from 0 to 3 (0 = no problems and 3 = severe problems). The overall PSQI score ranges from 0 to 21 points, with scores of > 5 indicating poorer sleep quality.
Time Frame
9 months
Title
Hospital anxiety-depression scale (HAD)
Description
To assess anxiety and depression symptoms the Hospital Anxiety and Depression Scale (HADS) was used; a validated 14 item self-reported measure (seven items associated with anxiety symptoms and seven with depression) over the last week. Each item is scored on a 4-point Likert scale (e.g., 0 = as much as I always do; 1 = not quite so much; 2 = definitely not so much; and 3 = not at all) giving maximum subscale scores of 21 for depression and anxiety, respectively. Scores of 0-7 are interpreted as normal; scores of 8-10 reflect mild symptoms, 11-14 moderate, and 15-21 severe for either anxiety or depression. The global HADS score ranges from 0 (no anxiety/depression) to 42 (severe anxiety/depression).
Time Frame
9 months
Title
Quality of life (SF-36)
Description
The SF-36 questionnaire was used to assess health-related quality of life. This is a 36-item broadly-based self-report survey of physical and mental functioning status related to health. The SF-36 assesses functioning on eight subscales including domains of physical functioning, physical role functioning, bodily pain, general health perception, vitality, social role functioning, emotional role functioning, and mental health. Lower scores indicate a more negative impact of an individual's health on functioning.
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients of both sexes, between 18-65 years.
Patients with a BMI ≤ 25.
Patients diagnosed with Chronic Fatigue Syndrome according to diagnostic criteria of 1994 CDC / Fukuda and 2003 Canadian criteria from the University of Central Sensitization Syndrome (Vall d'Hebron University Hospital, Barcelona).
Patients who freely grant written consent.
Exclusion Criteria:
Patients who are participating in another clinical trial of the same or different nature in the last 30 days prior to inclusion.
Any subject that, in the opinion of the investigator, is not able to follow the instructions or make a good completion of the treatment.
Subjects who do not grant written informed consent to participate in the study.
Patients who are receiving any of the prohibited drugs or products and that the withdrawal of the drugs / products not allowed in the study is expected to pose a relevant problem.
Pregnant women and / or during breastfeeding periods.
Patients under treatment with oral anticoagulants.
Patient with any type of immunosuppression.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Alegre, PhD
Organizational Affiliation
Hospital Vall d´Hebron
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28052319
Citation
Castro-Marrero J, Saez-Francas N, Santillo D, Alegre J. Treatment and management of chronic fatigue syndrome/myalgic encephalomyelitis: all roads lead to Rome. Br J Pharmacol. 2017 Mar;174(5):345-369. doi: 10.1111/bph.13702. Epub 2017 Feb 1.
Results Reference
background
PubMed Identifier
16817704
Citation
Barbado Hernandez FJ, Gomez Cerezo J, Lopez Rodriguez M, Vazquez Rodriguez JJ. [The chronic fatigue syndrome and its diagnosis in internal medicine]. An Med Interna. 2006 May;23(5):238-44. doi: 10.4321/s0212-71992006000500009. No abstract available. Spanish.
Results Reference
background
PubMed Identifier
17895634
Citation
Akramiene D, Kondrotas A, Didziapetriene J, Kevelaitis E. Effects of beta-glucans on the immune system. Medicina (Kaunas). 2007;43(8):597-606.
Results Reference
background
PubMed Identifier
22187640
Citation
El Khoury D, Cuda C, Luhovyy BL, Anderson GH. Beta glucan: health benefits in obesity and metabolic syndrome. J Nutr Metab. 2012;2012:851362. doi: 10.1155/2012/851362. Epub 2011 Dec 11.
Results Reference
background
PubMed Identifier
29272475
Citation
Ganda Mall JP, Casado-Bedmar M, Winberg ME, Brummer RJ, Schoultz I, Keita AV. A beta-Glucan-Based Dietary Fiber Reduces Mast Cell-Induced Hyperpermeability in Ileum From Patients With Crohn's Disease and Control Subjects. Inflamm Bowel Dis. 2017 Dec 19;24(1):166-178. doi: 10.1093/ibd/izx002. Erratum In: Inflamm Bowel Dis. 2018 Oct 12;24(11):2476.
Results Reference
background
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Clinical Trial to Assess the Improvement of Fatigue, Sleep Problems, Anxiety / Depression, Neurovegetatives Alterations and Quality of Life After the Administration of ImmunoVita® in Chronic Fatigue Syndrome Patients
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