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

Sponsor

Vitae Health Innovation (Industry)

Overall Status

Unknown status

CT.gov ID

NCT04301609

Collaborator

Hospital Vall d'Hebron (Other)

Enrollment

Arms

21.5

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Fatigue Syndrome Myalgic Encephalomyelitis	Dietary Supplement: Active Dietary Supplement: Placebo	N/A

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:

Analyze the efficacy of active ImmunoVita®, in patients with CFS / ME vs. placebo in the improvement of neurovegetative dysfunction, through the COMPASS 31 questionnaire.
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

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Mar 16, 2020

Anticipated Primary Completion Date :

Jan 16, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

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)	Dietary Supplement: Active Take 4 capsules daily (2 capsules on an empty stomach + 2 capsules 30 minutes before dinner). Other Names: ImmunoVita®
Placebo Comparator: Placebo 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).

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)

Dietary Supplement: Active

Take 4 capsules daily (2 capsules on an empty stomach + 2 capsules 30 minutes before dinner).

Other Names:

ImmunoVita®

Placebo Comparator: Placebo

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).

Outcome Measures

Primary Outcome Measures

Perception of fatigue (FIS-40). [9 months]
The objective of this study is to assess the efficacy of active ImmunoVita® in patients with CFS vs. placebo in the perception of fatigue, evaluated through the scale of perception of fatigue (FIS-40).

Secondary Outcome Measures

Neurovegetative alterations (COMPASS 31) [9 months]
To analyze the efficacy of the active product, in patients with CFS / ME versus placebo in the improvement of neurovegetative dysfunction, through the COMPASS 31 questionnaire.
Sleep dysfunction (Pittsburg questionnaire) [9 months]
To evaluate the efficacy of the active product, in patients with CFS / ME vs. placebo in the improvement of sleep dysfunction, through the Pittsburg questionnaire.
Hospital anxiety-depression scale (HAD) [9 months]
To analyze the efficacy of the active product, in patients with CFS / ME vs. placebo in the improvement of anxiety-depressive symptomatology, through the hospital anxiety-depression scale (HAD)
Quality of life (SF-36) [9 months]
To evaluate the efficacy of the active product, in patients with CFS / ME vs. placebo in the improvement of the quality of life, through the SF-36 questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.