NCT04301609 is a NA clinical trial of Active in Chronic Fatigue Syndrome, sponsored by Vitae Health Innovation.

Who is sponsoring NCT04301609?

NCT04301609 is sponsored by Vitae Health Innovation.

What drugs are being tested in NCT04301609?

Interventions in NCT04301609: Active, Placebo.

What condition does NCT04301609 study?

NCT04301609 studies Chronic Fatigue Syndrome, Myalgic Encephalomyelitis.

Is NCT04301609 still recruiting?

NCT04301609 is currently completed. Last updated 15 March 2023.

Last reviewed 2023-03-15 · How we verify

NCT04301609

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 15 March 2023

What this trial tests

NA trial testing Active in Chronic Fatigue Syndrome in 67 participants. Completed in 31 January 2023.

Timeline

10 November 2021

Primary endpoint
30 December 2022

31 January 2023

Quick facts

Lead sponsor	Vitae Health Innovation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	67
Start date	10 November 2021
Primary completion	30 December 2022
Estimated completion	31 January 2023
Sites	1 location across Spain

Drugs / interventions tested

Active (active) — full drug profile →
Placebo

Conditions studied

Chronic Fatigue Syndrome — all drugs for Chronic Fatigue Syndrome →
Myalgic Encephalomyelitis — all drugs for Myalgic Encephalomyelitis →

Sponsor

Vitae Health Innovation

Who can join

Adults 18 to 65, any sex, with Chronic Fatigue Syndrome or Myalgic Encephalomyelitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Yeast Beta-Glucan Supplementation with Multivitamins Attenuates Cognitive Impairments in Individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial.
Lacasa M, Alegre-Martin J, Sentañes RS, Varela-Sende L, et al · · 2023 · cited 5× · PMID 37960157 · DOI 10.3390/nu15214504

Verify or expand the search:

Other trials of Active

Trials testing the same drug.

NCT07109713 — The Effect Cranberry-Based Products on the Female Microbiome · NA · recruiting
NCT06663865 — Investigating the Effects of Dairy Phospholipids on Sleep and Daytime Function in Healthy Adults. · NA · not yet recruiting
NCT06102174 — A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children Wi · Phase 1 · terminated
NCT06109922 — Investigating the Effects of Dietary Phospholipids on Stress Reactivity and Recovery · NA · completed
NCT06107075 — Investigating the Effects of Dietary Phospholipids on Measures of Human Brain Health and Psychological Wellbeing · NA · recruiting

Other recruiting trials for Chronic Fatigue Syndrome

Currently open trials in the same condition.

NCT07009691 — Hydrogen Water Intervention With Heart Rate Variability as an Outcome Biomarker in ME/CFS · NA · recruiting
NCT06585254 — tVNS in Long COVID-19 · NA · recruiting
NCT05741112 — The Long COVID-19 Wearable Device Study · NA · recruiting
NCT05967052 — Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitati · Phase 2 · recruiting
NCT05525598 — Internet-based Treatment for Patients Suffering From Severe Functional Somatic Disorders · NA · recruiting

Other Vitae Health Innovation trials

Trials by the same sponsor.

NCT06987396 — Clinical Investigation to Assess the Effect of Betaglucan Administration in HPV Patients · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04301609 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vitae Health Innovation
Last refreshed: 15 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04301609.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing