- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04301609
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
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 Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jesús Castro-Marrero, PhD
- Phone Number: 3753 + 34 93 4893000
- Email: jesus.castro@vhir.org
Study Contact Backup
- Name: Aleix P. Cuenca, MD
- Phone Number: +34 658089458
- Email: apellejero@vitae.es
Study Locations
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-
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Barcelona, Spain, 08035
- Hospital Vall d'Hebron
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ImmunoVita®
250 mg Yeast beta-glucan + 3.75 microg Vitamin D3 + 1.05 mg Vitamin B6 + 7.5 mg zinc)
|
Take 4 capsules daily (2 capsules on an empty stomach + 2 capsules 30 minutes before dinner).
Other Names:
|
Placebo Comparator: Placebo
473,2 mg microcristalline cellulose + 0,06 mg Brown Oxide dye + 0,27 mg yellow A oxide dye
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Take 4 capsules daily (2 capsules on an empty stomach + 2 capsules 30 minutes before dinner).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perception of fatigue (FIS-40).
Time Frame: 9 months
|
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.
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep dysfunction (Pittsburg questionnaire)
Time Frame: 9 months
|
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.
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9 months
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Hospital anxiety-depression scale (HAD)
Time Frame: 9 months
|
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).
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9 months
|
Quality of life (SF-36)
Time Frame: 9 months
|
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.
|
9 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: José Alegre, PhD, Hospital Vall d´hebron
Publications and helpful links
General Publications
- 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.
- 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.
- Akramiene D, Kondrotas A, Didziapetriene J, Kevelaitis E. Effects of beta-glucans on the immune system. Medicina (Kaunas). 2007;43(8):597-606.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR(AG)447/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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