Use of 1-MNA to Improve Exercise Tolerance and Fatigue in Patients After COVID-19

NCT ID: NCT04961476

Last Updated: 2021-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-08

Study Completion Date

2021-03-05

Brief Summary

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Coronavirus disease 2019 (COVID-19) is a serious respiratory disease that results from infection with a newly discovered coronavirus (SARS-COV-2). Unfortunately, COVID-19 is not only a short-term infection but that patients (pts) recovering from SARS-COV2 infection complain of persisting symptoms including: fatigue, diffuse myalgia and weakness, which may lead to chronic fatigue syndrome. There is currently no evidence that nutritional supplements and/or physical exercise can assist in the recovery of pts with chronic fatigue syndrome. 1-Methylnicotinamide (1-MNA) is an endogenic substance that is produced in the liver when nicotinic acid is metabolized. 1-MNA demonstrates anti-inflammatory and anti-thrombotic properties. Therefore, we investigated whether 1-MNA supplements could improve exercise tolerance and decrease fatigue among patients recovering from SARS-COV-2.

Detailed Description

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The study population was composed of pts after COVID-19, expressing subjective feelings of limited tolerance to exercise. The selected pts were randomized into two groups: GrM0 - without supplementation; GrM1 - with 1-MNA supplementation. At the beginning of the study (Phase 0), in both groups, a 6-minute walk test (6MWT) was carried out and fatigue assessment with Fatigue Severity Scale (FSS) was performed. After 1 month (Phase 1), a fol-low up FSS and 6MWT once more were performed in both groups.

Conditions

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Covid19 Fatigue Syndrome, Chronic

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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GrM0

GrM0 - without supplementation

No interventions assigned to this group

GrM1

GrM1 - with 1-MNA supplementation

1-MNA

Intervention Type DIETARY_SUPPLEMENT

1-MNA supplementation

Interventions

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1-MNA

1-MNA supplementation

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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1-Methylnicotinamide

Eligibility Criteria

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Inclusion Criteria

* Patients after COVID-19
* Patients expressing subjective feelings of limited tolerance to exercise and above 50% greater fatigue compared to their pre-COVID-19 levels (symptoms must have continued for at least four weeks since the last symptoms of infection)

Exclusion Criteria

* Patients with cardiological complications
* Patients with pulmonological complications
* Patients with Chronic Obstructive Pulmonary Disease and/or asthma
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michal Chudzik

OTHER

Sponsor Role lead

Responsible Party

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Michal Chudzik

Medical Doctor, Cardiologist, Medical Director Ambulatory Clinic

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Medical Center, Saint Family Hospital

Lodz, , Poland

Site Status

Countries

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Poland

Other Identifiers

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Stop-Covid/1/2020

Identifier Type: -

Identifier Source: org_study_id

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