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

Completed

• Conditions: Covid19; Fatigue Syndrome, Chronic
• Interventions: Dietary Supplement: 1-MNA

• Registration Number: NCT04961476
• Lead Sponsor: Michal Chudzik

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.

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 Timeline

• Study Start: 2021-01-08
• Primary Completion: 2021-03-05
• Study Completion: 2021-03-05
• Status Verified: 2021-07
• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-07-12
• Study First Posted: 2021-07-14
• Last Update Submitted: 2021-07-14
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GrM1	1-MNA	GrM1 - with 1-MNA supplementation

Primary Outcome Measures

Name	Time	Method
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.
6MWT	1 Month	6-Minute Walk Test - Walking distance in meters in 6-minute walk test

Trial Locations

Locations (1)

Medical Center, Saint Family Hospital; 🇵🇱 Łódź, Poland