Kinetics and Metabolism of Nicotinamide Provided as a Dietary Supplementation
CICR-NAM_PK
1 other identifier
interventional
28
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedFirst Submitted
Initial submission to the registry
July 28, 2025
CompletedFirst Posted
Study publicly available on registry
September 5, 2025
CompletedSeptember 5, 2025
September 1, 2025
1.1 years
July 28, 2025
September 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From baseline (day 1) until day 2 (minimum), day 3 or day 8
Secondary Outcomes (3)
Changes in serum concentrations of tryptophan and its metabolites
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)
Weekly from baseline until week 4
Changes in fatigue (Functional Assessment of Chronic Illness Therapy - Fatigue [FACIT-F] questionnaire; optional)
Weekly from baseline until week 4
Study Arms (2)
500 mg/d CICR-NAM
ACTIVE COMPARATOR500 mg/d controlled-ileocolonic-release nicotinamide for 28 d
1000 mg/d CICR-NAM
ACTIVE COMPARATOR500 mg/d controlled-ileocolonic-release nicotinamide for 28 d
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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 pump inhibitors, H2 receptor antagonists or antacids) in higher doses over a longer period of time.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, 24105, Germany
Related Publications (1)
Schreiber S, Waetzig GH, Lopez-Agudelo VA, Geisler C, Schlicht K, Franzenburg S, di Giuseppe R, Pape D, Bahmer T, Krawczak M, Kokott E, Penninger JM, Harzer O, Kramer J, von Schrenck T, Sommer F, Zacharias HU; COVit-2 Study Group; Millet Pascual-Leone B, Forslund SK, Heyckendorf J, Aden K, Hollweck R, Laudes M, Rosenstiel P. Nicotinamide modulates gut microbial metabolic potential and accelerates recovery in mild-to-moderate COVID-19. Nat Metab. 2025 Jun;7(6):1136-1149. doi: 10.1038/s42255-025-01290-1. Epub 2025 May 12.
PMID: 40355744BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Schreiber, Prof. Dr. Dr. h.c.
University Hospital Schleswig-Holstein
- PRINCIPAL INVESTIGATOR
Jan Heyckendorf, Prof. Dr.
University Hospital Schleswig-Holstein
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2025
First Posted
September 5, 2025
Study Start
April 20, 2024
Primary Completion
May 20, 2025
Study Completion
June 30, 2025
Last Updated
September 5, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
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.