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Kinetics and Metabolism of Nicotinamide Provided as a Dietary Supplementation

NCT07156929 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-09-05

No results posted yet for this 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.

Conditions

  • Respiratory Infection (for Example, Pneumonia, Bronchitis)
  • Respiratory Infection Virus
  • Community Acquired Pneumonia (CAP)
  • COPD Acute Exacerbation
  • Inflammatory Bowel Disease (IBD)

Interventions

DIETARY_SUPPLEMENT

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

Controlled-ileocolonic-release nicotinamide (CICR-NAM) film-coated tablets release 500 mg nicotinamide per tablet at a pH of 7, leading to a delayed and prolonged systemic exposure to nicotinamide and to exposure of the ileum and colon including the gut microbiome.

DIETARY_SUPPLEMENT

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

Controlled-ileocolonic-release nicotinamide (CICR-NAM) film-coated tablets release 500 mg nicotinamide per tablet at a pH of 7, leading to a delayed and prolonged systemic exposure to nicotinamide and to exposure of the ileum and colon including the gut microbiome.

Sponsors & Collaborators

  • University Hospital Schleswig-Holstein

    lead OTHER

Principal Investigators

  • Stefan Schreiber, Prof. Dr. Dr. h.c. · University Hospital Schleswig-Holstein

  • Jan Heyckendorf, Prof. Dr. · University Hospital Schleswig-Holstein

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-20
Primary Completion
2025-05-20
Completion
2025-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07156929 on ClinicalTrials.gov