Use of 1-MNA to Improve Exercise Tolerance and Fatigue in Patients After COVID-19
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2021
CompletedFirst Submitted
Initial submission to the registry
July 12, 2021
CompletedFirst Posted
Study publicly available on registry
July 14, 2021
CompletedJuly 21, 2021
July 1, 2021
2 months
July 12, 2021
July 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
6MWT
6-Minute Walk Test - Walking distance in meters in 6-minute walk test
1 Month
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
Study Arms (2)
GrM0
GrM0 - without supplementation
GrM1
GrM1 - with 1-MNA supplementation
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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)
You may not qualify if:
- Patients with cardiological complications
- Patients with pulmonological complications
- Patients with Chronic Obstructive Pulmonary Disease and/or asthma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michal Chudziklead
Study Sites (1)
Medical Center, Saint Family Hospital
Lodz, 90-302, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Medical Doctor, Cardiologist, Medical Director Ambulatory Clinic
Study Record Dates
First Submitted
July 12, 2021
First Posted
July 14, 2021
Study Start
January 8, 2021
Primary Completion
March 5, 2021
Study Completion
March 5, 2021
Last Updated
July 21, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share