Kinetics and Metabolism of Nicotinamide Provided as a Dietary Supplementation

Last updated: September 3, 2025
Sponsor: University Hospital Schleswig-Holstein
Overall Status: Completed

Phase

N/A

Condition

Pneumonia

Inflammatory Bowel Disease

Pneumonia (Pediatric)

Treatment

Controlled-ileocolonic-release nicotinamide (CICR-NAM): 500 mg/d

Controlled-ileocolonic-release nicotinamide (CICR-NAM): 1000 mg/d

Clinical Study ID

NCT07156929
D 417/24
  • Ages > 18
  • All Genders

Study Summary

The diet of patients with reduced tryptophan serum levels that are either hospitalized for acute respiratory infection or treated for chronic inflammatory diseases such as inflammatory bowel diseases (in- or outpatients) is supplemented with controlled-ileocolonic-release nicotinamide (CICR-NAM) at doses of 500 mg or 1000 mg per day for four weeks. In the COVit-2 trial (NCT04751604), nicotinamide supplementation including CICR-NAM has been shown to accelerate physical recovery from mild-to-moderate COVID-19 (for publication, see References). The main objective of this open-label case series is to investigate the pharmacokinetics and metabolism of nicotinamide in patients with more severe respiratory infections or chronic inflammatory conditions. In addition, patients can optionally provide information on their quality of life and fatigue status.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Serum tryptophan levels below normal range.

  • Acute, infectious respiratory disease requiring treatment (e.g. proven acuteSARS-CoV-2 or influenza virus infection with inpatient treatment) or chronicinflammatory disease (e.g. chronic inflammatory bowel disease) in remission or inacute relapse (outpatient or inpatient treatment).

Exclusion

Exclusion Criteria:

  • Inability to give informed consent.

  • Pregnancy or breastfeeding.

  • Serious other illness, e.g. cancer.

  • Anemia: Hb <10 mg/dL.

  • Intake of medication to raise the pH value in the stomach (e.g. proton pumpinhibitors, H2 receptor antagonists or antacids) in higher doses over a longerperiod of time.

Study Design

Total Participants: 28
Treatment Group(s): 2
Primary Treatment: Controlled-ileocolonic-release nicotinamide (CICR-NAM): 500 mg/d
Phase:
Study Start date:
April 20, 2024
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • University Hospital Schleswig-Holstein, Campus Kiel

    Kiel 2891122, Schleswig-Holstein 2838632 24105
    Germany

    Site Not Available

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