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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Schleswig-Holstein

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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);

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: CICR-NAM AdministrationExperimental treatment 1 intervention

Trial outcomes

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)

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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