Trials / Completed
CompletedNCT07156929
Kinetics and Metabolism of Nicotinamide Provided as a Dietary Supplementation
Kinetics and Metabolism of Nicotinamide Provided as a Dietary Supplementation: CICR-NAM as Food for Special Medicinal Purposes (FSMP)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- University Hospital Schleswig-Holstein · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-04-20
- Primary completion
- 2025-05-20
- Completion
- 2025-06-30
- First posted
- 2025-09-05
- Last updated
- 2025-09-05
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT07156929. Inclusion in this directory is not an endorsement.