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

Sponsor

Michal Chudzik (Other)

Overall Status

Completed

CT.gov ID

NCT04961476

Collaborator

(none)

Enrollment

Location

1.8

Actual Duration (Months)

27.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Fatigue Syndrome, Chronic	Dietary Supplement: 1-MNA

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

50 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 8, 2021

Actual Primary Completion Date :

Mar 5, 2021

Actual Study Completion Date :

Mar 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
GrM0 GrM0 - without supplementation
GrM1 GrM1 - with 1-MNA supplementation	Dietary Supplement: 1-MNA 1-MNA supplementation Other Names: 1-Methylnicotinamide

Arm

Intervention/Treatment

GrM0

GrM0 - without supplementation

GrM1

GrM1 - with 1-MNA supplementation

Dietary Supplement: 1-MNA

1-MNA supplementation

Other Names:

1-Methylnicotinamide

Outcome Measures

Primary Outcome Measures

6MWT [1 Month]
6-Minute Walk Test - Walking distance in meters in 6-minute walk test
FSS [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)