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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04961476
• Other study ID #: Stop-Covid/1/2020
• Status: Completed
• Start date: January 8, 2021
• Est. completion date: March 5, 2021

Study information

• Verified date: July 2021
• Source: Saint Family Hospital Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 5, 2021
• Est. primary completion date: March 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Fatigue
• Fatigue Syndrome, Chronic
• Syndrome

Intervention

Dietary Supplement:
• 1-MNA
1-MNA supplementation

Locations

Country	Name	City	State
Poland	Medical Center, Saint Family Hospital	Lódz

Sponsors (1)

Lead Sponsor	Collaborator
Michal Chudzik

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6MWT	6-Minute Walk Test - Walking distance in meters in 6-minute walk test	1 Month
Primary	FSS	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