U09.9
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: – Post-COVID syndrome (PCS) – Serum tryptophan <55 µmol/L (UKSH reference range: 48–109 µmol/L) – Minimum age 18 years – Participation in the therapy groups of the PCS outpatient clinic at UKSH Campus Kiel
Exclusion criteria
Exclusion criteria: o Known allergies or intolerances to components of CICR-NAM. o Lack of capacity to provide consent. o Pregnancy or breastfeeding. o .Severe other disease, particularly renal insufficiency, uncontrolled autoimmune diseases, liver diseases and cancers. o Use of medications that increase gastric pH, such as proton pump inhibitors, H2 receptor antagonists or antacids, at higher doses over a prolonged period, as an increase in pH to around pH 7 could lead to premature release of nicotinamide from CICR-NAM. o Use of dietary supplements containing >20 mg nicotinamide, nicotinamide riboside, nicotinamide mononucleotide, nicotinic acid or NAD+ per daily dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WHAT: Serum tryptophan level (µmol/L) as a longitudinal parameter of tryptophan and NAD+ metabolism during CICR-NAM supplementation. WHEN: Monthly therapy group unit 1 (start of participation in the therapy group, screening for reduced serum tryptophan, T1), unit 2 (start of supplementation, T2), unit 3 (after approximately 1 month of supplementation, T3), unit 6 (end of the therapy group; after approximately 4 months, T4). HOW: Quantitative determination of tryptophan in serum (UKSH laboratory diagnostics). | — |
Secondary
| Measure | Time frame |
|---|---|
| o SF-36 questionnaire; units 1, 4 and 6. o Adherence: counting of unused tablets/blisters; units 3–6 (return at unit 6). o Metabolomics, particularly tryptophan and NAD+ metabolites (serum) as well as NAD+ (whole blood); units 2, 3 and 6. | — |
Countries
Germany
Contacts
Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel, Klinik für Innere Medizin 1