An interventional study of Controlled-ileocolonic-release nicotinamide (CICR-NAM): 500 mg/d and Controlled-ileocolonic-release nicotinamide (CICR-NAM): 1000 mg/d in Respiratory Infection (for Example, Pneumonia, Bronchitis), Respiratory Infection Virus and Community Acquired Pneumonia (CAP), sponsored by University Hospital Schleswig-Holstein. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-05.
Sponsored by University Hospital Schleswig-Holstein · Not applicable, Interventional, and Other
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.
751 studies on the registry are indexed under Respiratory Tract Infections; 114 are open to participants now.
This study's enrollment of 28 is below the median of 200 across 540 interventional studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →University Hospital Schleswig-Holstein is the lead sponsor of 163 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
500 mg/d controlled-ileocolonic-release nicotinamide for 28 d
Dietary Supplement: Controlled-ileocolonic-release nicotinamide (CICR-NAM): 500 mg/d
500 mg/d controlled-ileocolonic-release nicotinamide for 28 d
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.
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.
Changes in plasma concentrations of nicotinamide (NAM) and its main metabolites N-methylnicotinamide (NMN) and N-methyl-2-pyridone-5-carboxamide (2-Py) as well as nicotinic acid (NA) and nicotinuric acid (NUA)
Simultaneous measurement by liquid chromatography with tandem mass spectrometry.
Time frame: From baseline (day 1) until day 2 (minimum), day 3 or day 8
Changes in serum concentrations of tryptophan and its metabolites
Simultaneous measurement by liquid chromatography with tandem mass spectrometry.
Time frame: From baseline (day 1) until day 2 (minimum), day 3 or day 8
Changes in quality of life (EuroQoL 5 Dimensions 5 Levels [EQ-5D-5L] questionnaire; optional)
The EQ-5D-5L health states can be summarised using a 5-digit code representing the 5 dimensions 'mobility', 'self-care', 'activity', 'pain' and 'anxiety' with 5 levels each from 1 = no problem to 5 = maximum problem. In addition, the subjects report their overall self-perceived health-related quality of life using the Visual Analogue Scale (VAS) from 0 = worst health one can imagine to 100 = best health one can imagine.
Time frame: Weekly from baseline until week 4
Changes in fatigue (Functional Assessment of Chronic Illness Therapy - Fatigue [FACIT-F] questionnaire; optional)
The FACIT-F questionnaire is a 40-item measure that assesses self-reported fatigue and its impact upon daily activities and function. The higher the subscores and total score, the better the self-perceived quality of life (for the total score, the range is from 0 to 160).
Time frame: Weekly from baseline until week 4
Plan to share: Yes — Specific requests by academic researchers can be addressed to the principal investigators. On the basis of such a request including a detailed analysis plan, access might be provided, subject to a decision of the Ethics Committee of the Medical Faculty of Kiel University to ensure compliance with privacy laws, data protection and requirements for consent and anonymization.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Respiratory Tract Infections →
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