NCT07156929Completed
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)
Source: ClinicalTrials.gov · Last updated 5 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 28 (actual)
- First submitted
- 28 Jul 2025
- Start date
- 20 Apr 2024
- Primary completion date
- 20 May 2025
- Lead sponsor
- University Hospital Schleswig-Holstein
- Diseases
- Crohn's disease, COPD
- NCT number
- NCT07156929
What you commit to
- Study type: Interventional
- Participants enrolled: 28
- From 20 Apr 2024 to the primary completion date, 20 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intake of medication to raise the pH value in the stomach (e.g. proton pump inhibitors, H2 receptor antagonists or antacids) in higher doses over a longer period of time.
Other illness
- Serious other illness, e.g. cancer.
Lab values
- Anemia: Hb \<10 mg/dL.
Other
- Inability to give informed consent.
- Pregnancy or breastfeeding.
Who the study is looking for
- Serum tryptophan levels below normal range.
- Acute, infectious respiratory disease requiring treatment (e.g. proven acute SARS-CoV-2 or influenza virus infection with inpatient treatment) or chronic inflammatory disease (e.g. chronic inflammatory bowel disease) in remission or in acute relapse (outpatient or inpatient treatment).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Schleswig-Holstein, Campus KIEL Coordinator of this site? Confirm its status | Kiel | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.