An interventional study of Active and Placebo in Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, sponsored by Vitae Health Innovation. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-03-15.
Sponsored by Vitae Health Innovation · Not applicable, Interventional, and Treatment
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.
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.
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:
263 studies on the registry are indexed under Fatigue Syndrome, Chronic; 61 are open to participants now.
This study's enrollment of 67 is above the median of 60 across 177 interventional studies indexed under Fatigue Syndrome, Chronic.
Browse Fatigue Syndrome, Chronic studies →Vitae Health Innovation is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
250 mg Yeast beta-glucan + 3.75 microg Vitamin D3 + 1.05 mg Vitamin B6 + 7.5 mg zinc)
Dietary Supplement: Active
473,2 mg microcristalline cellulose + 0,06 mg Brown Oxide dye + 0,27 mg yellow A oxide dye
Dietary Supplement: Placebo
Take 4 capsules daily (2 capsules on an empty stomach + 2 capsules 30 minutes before dinner).
Also known as: ImmunoVita®
Take 4 capsules daily (2 capsules on an empty stomach + 2 capsules 30 minutes before dinner).
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.
Time frame: 9 months
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.
Time frame: 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).
Time frame: 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.
Time frame: 9 months
Plan to share: No
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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