Chronic Fatigue SyndromeNCT04301609
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
A study testing Active in people with Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, run by Vitae Health Innovation at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
- What is being tested?
- Active
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteSpain
- Study dates
- 10 Nov 2021to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Active, Placebo
- Keywords
- Fatigue Syndrome, Encephalomyelitis, Fibromyalgia
- Medical subject headings
- Fatigue Syndrome, Chronic, Encephalomyelitis, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiveDietary supplement
Also called ImmunoVita®
Take 4 capsules daily (2 capsules on an empty stomach + 2 capsules 30 minutes before dinner).
PlaceboDietary supplement
Take 4 capsules daily (2 capsules on an empty stomach + 2 capsules 30 minutes before dinner).
| Study group | Role | What they receive |
|---|---|---|
| ImmunoVita® | Active comparator | 250 mg Yeast beta-glucan + 3.75 microg Vitamin D3 + 1.05 mg Vitamin B6 + 7.5 mg zinc) Receives: Dietary Supplement: Active |
| Placebo | Placebo comparator | 473,2 mg microcristalline cellulose + 0,06 mg Brown Oxide dye + 0,27 mg yellow A oxide dye Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (3)
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.
Measured: 9 months
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).
Measured: 9 months
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start10 Nov 2021
- Primary completion30 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitae Health Innovation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Vall d'Hebron
- Responsible party
- Sponsor
- Investigators
- José Alegre, PhD, Principal investigator, Hospital Vall d´Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301609
- Sponsor's protocol ID
- PR(AG)447/2019
- Status last verified
- Mar 2023
- First submitted
- 4 Mar 2020
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28052319Barbado 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.
PubMed 16817704Akramiene D, Kondrotas A, Didziapetriene J, Kevelaitis E. Effects of beta-glucans on the immune system. Medicina (Kaunas). 2007;43(8):597-606.
PubMed 17895634El 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.
PubMed 22187640Ganda 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.
PubMed 29272475
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04301609
- Acronym / sponsor ID
- PR(AG)447/2019
- Keywords
- Fatigue Syndrome, Encephalomyelitis, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Vitae Health InnovationIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Vall d'Hebron
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ImmunoVita® | Active comparator | Dietary Supplement: Active250 mg Yeast beta-glucan + 3.75 microg Vitamin D3 + 1.05 mg Vitamin B6 + 7.5 mg zinc) |
| Placebo | Placebo comparator | Dietary Supplement: Placebo473,2 mg microcristalline cellulose + 0,06 mg Brown Oxide dye + 0,27 mg yellow A oxide dye |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActiveAlso: ImmunoVita®Take 4 capsules daily (2 capsules on an empty stomach + 2 capsules 30 minutes before dinner). | Dietary supplement | ImmunoVita® |
| PlaceboTake 4 capsules daily (2 capsules on an empty stomach + 2 capsules 30 minutes before dinner). | Dietary supplement | Placebo |
Primary outcome
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.
3 secondary outcomes
Sleep dysfunction (Pittsburg questionnaire)
Time frame: 9 months
Hospital anxiety-depression scale (HAD)
Time frame: 9 months
Quality of life (SF-36)
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Background: PubMed 28052319Castro-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.
- Background: PubMed 16817704Barbado 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.
- Background: PubMed 17895634Akramiene D, Kondrotas A, Didziapetriene J, Kevelaitis E. Effects of beta-glucans on the immune system. Medicina (Kaunas). 2007;43(8):597-606.
- Background: PubMed 22187640El 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.
- Background: PubMed 29272475Ganda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Alegre, PhD principal investigator
Hospital Vall d´Hebron
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active in people with Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, run by Vitae Health Innovation at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of fatigue (FIS-40). (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04301609, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.