Observational Study With CICR-NAM as a Food for Special Medicinal Purposes in Post-COVID Syndrome (PCS)

NCT07798570 | Not Yet Recruiting

• 1 other identifier: CICR-NAM-PCS_V01_2026
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Post COVID Syndrome Long Covid

Outcome Measures

Primary Outcomes (1)

• Serum tryptophan level

  Serum tryptophan level (µmol/L) as a longitudinal marker of tryptophan and NAD+ metabolism during CICR-NAM supplementation. Assessment time points: therapy group session 1 (start of participation, screening for reduced serum tryptophan, T1), session 2 (start of supplementation, T2), session 3 (after approximately 1 month of supplementation, T3), and session 6 (end of the therapy group, after approximately 4 months, T4). Method: quantitative determination of serum tryptophan (UKSH laboratory diagnostics)

  From T1 (start of participation, screening for reduced serum tryptophan) to T6 (end of the therapy group) approximately 5 month.

Study Arms (1)

CICR-NAM Administration

EXPERIMENTAL

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, embedded in the therapy groups of the PCS outpatient clinic at UKSH Campus Kiel.

Dietary Supplement: CICR-NAM

Interventions

CICR-NAM DIETARY_SUPPLEMENT

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, embedded in the therapy groups of the PCS outpatient clinic at UKSH Campus Kiel

CICR-NAM Administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all sexes;
• minimum age 18 years; no upper age limit;
• post-COVID syndrome (PCS)
• serum tryptophan \<55 µmol/L (UKSH reference range: 48-109 µmol/L);
• participation in the therapy groups of the PCS outpatient clinic at UKSH Campus Kiel.

You may not qualify if:

• Known allergies or intolerances to any component of CICR-NAM;
• inability to provide informed consent;
• pregnancy or breastfeeding;
• severe comorbid disease (especially renal insufficiency, uncontrolled autoimmune diseases, liver disease, or malignancy);
• long-term use of higher doses of medications that raise gastric pH (for example proton pump inhibitors, H2 receptor antagonists, or antacids), as an increase in pH toward approximately 7 may cause premature release of nicotinamide from CICR-NAM;
• use of supplements containing more than 20 mg nicotinamide, nicotinamide riboside, nicotinamide mononucleotide, nicotinic acid, or NAD+ per daily dose.

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Central Study Contacts

Lennart Reinke, Dr. med.

CONTACT

+49 431 500-22200; lennartmichel.reinke@uksh.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: September 1, 2026
• Study Start: September 6, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share