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NCT07798570
Observational Study With CICR-NAM as a Food for Special Medicinal Purposes in Post-COVID Syndrome (PCS)
Conditions: Post COVID Syndrome Long Covid
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: University Hospital Schleswig-Holstein
Location: University Hospital Schleswig Holstein Kiel
Summary
In patients with post-COVID syndrome, changes in tryptophan metabolism, energy metabolism, and the gut microbiome may occur. In an earlier nutritional study, patients with COVID-19 recovered their physical performance more quickly when taking nicotinamide (vitamin B3). Patients who responded to nicotinamide also developed post-COVID syndrome less frequently. At the University Hospital Schleswig-Holstein in Kiel, special nicotinamide tablets (CICR-NAM) were developed that release the active substance selectively in the lower intestine and have been shown to be very well tolerated in several studies.
Patients with post-COVID syndrome and documented tryptophan deficiency may therefore take one tablet (500 mg) of CICR-NAM daily for up to approximately 4 months as a food for special medicinal purposes within the therapy groups of the outpatient clinic for patients with post-COVID syndrome at the University Hospital Schleswig-Holstein in Kiel. This intake is far below the Upper Level defined by the European Food Safety Authority for lifelong daily intake (900 mg per day). Therefore, there are no safety concerns. CICR-NAM intake is intended to complement the therapy group programme by supporting energy metabolism.
Eligibility Criteria
Inclusion Criteria:
* all sexes;
* minimum age 18 years; no upper age limit;
* post-COVID syndrome (PCS)
* serum tryptophan \
Source: ClinicalTrials.gov (NCT07798570). StuddyBuddy aggregates publicly available trial information.