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

July 14, 2021 updated by: Michal Chudzik
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Łódź, Poland, 90-302
        • Medical Center, Saint Family Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GrM0
GrM0 - without supplementation
GrM1
GrM1 - with 1-MNA supplementation
Dietary supplement: 1-MNA
1-MNA supplementation
Other Names:
  • 1-Methylnicotinamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6MWT
Time Frame: 1 Month
6-Minute Walk Test - Walking distance in meters in 6-minute walk test
1 Month
FSS
Time Frame: 1 Month
Fatigue Severity Scale - a self-administered questionnaire for assessing the severity of fatigue in different situations over the past week. Each item is rated on a scale from 1 to 7, where 1 indicates strong disagreement and 7 strong agreement.
1 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michal Chudzik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2021

Primary Completion (Actual)

March 5, 2021

Study Completion (Actual)

March 5, 2021

Study Registration Dates

First Submitted

July 12, 2021

First Submitted That Met QC Criteria

July 12, 2021

First Posted (Actual)

July 14, 2021

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 14, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stop-Covid/1/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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