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

NCT04301609 | Completed DMC

• 1 other identifier: PR(AG)447/2019
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Fatigue Syndrome; Myalgic Encephalomyelitis

Keywords

Fatigue Syndrome; Encephalomyelitis; Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• 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.

  9 months

Secondary Outcomes (3)

• Sleep dysfunction (Pittsburg questionnaire)

  9 months

• Hospital anxiety-depression scale (HAD)

  9 months

• Quality of life (SF-36)

  9 months

Study Arms (2)

ImmunoVita®

ACTIVE COMPARATOR

250 mg Yeast beta-glucan + 3.75 microg Vitamin D3 + 1.05 mg Vitamin B6 + 7.5 mg zinc)

Dietary Supplement: Active

Placebo

PLACEBO COMPARATOR

473,2 mg microcristalline cellulose + 0,06 mg Brown Oxide dye + 0,27 mg yellow A oxide dye

Dietary Supplement: Placebo

Interventions

Active DIETARY_SUPPLEMENT

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

Also known as: ImmunoVita®

ImmunoVita®

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vitae Health Innovation: lead
• Hospital Vall d'Hebron: collaborator

Study Sites (1)

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (5)

• 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.

  PMID: 28052319 BACKGROUND

• 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.

  PMID: 16817704 BACKGROUND

• Akramiene D, Kondrotas A, Didziapetriene J, Kevelaitis E. Effects of beta-glucans on the immune system. Medicina (Kaunas). 2007;43(8):597-606.

  PMID: 17895634 BACKGROUND

• 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.

  PMID: 22187640 BACKGROUND

• 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.

  PMID: 29272475 BACKGROUND

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Encephalomyelitis; Fibromyalgia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Infections; Infections; Central Nervous System Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• José Alegre, PhD

  Hospital Vall d´Hebron

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 10, 2020
• Study Start: November 10, 2021
• Primary Completion: December 30, 2022
• Study Completion: January 31, 2023
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)