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Observational study with CICR-NAM as a food for special medicinal purposes in post-COVID syndrome (PCS)

Observational study with CICR-NAM as a food for special medicinal purposes in post-COVID syndrome (PCS) - CICR-NAM-PCS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00040838
Enrollment
100
Registered
2026-07-06
Start date
2026-08-11
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

U09.9

Interventions

Group 1: Oral administration of CICR-NAM (controlled-ileocolonic-release nicotinamide) as a food for special medical purposes, one film-coated tablet (500 mg) daily for up to approximately 4 months, e

Sponsors

Universitätsklinikum Schleswig-Holstein (UKSH)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime 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

MeasureTime 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

Public ContactLennart Reinke

Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel, Klinik für Innere Medizin 1

lennartmichel.reinke@uksh.de004943150022200

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026