Respiratory Infection (for Example, Pneumonia, Bronchitis)CICR-NAM_PKNCT07156929
Kinetics and Metabolism of Nicotinamide Provided as a Dietary Supplementation
A study of Respiratory Infection (for Example, Pneumonia, Bronchitis) and Respiratory Infection Virus, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Infection (for Example, Pneumonia, Bronchitis), Respiratory Infection Virus, Community Acquired Pneumonia (CAP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- 20 Apr 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, 24105
About this study
Official title: Kinetics and Metabolism of Nicotinamide Provided as a Dietary Supplementation: CICR-NAM as Food for Special Medicinal Purposes (FSMP)
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)
- Being tested
- Controlled-ileocolonic-release nicotinamide (CICR-NAM): 500 mg/d, Controlled-ileocolonic-release nicotinamide (CICR-NAM): 1000 mg/d
- Keywords
- Nicotinamide, Controlled-Ileocolonic-Release Nicotinamide, CICR-NAM, Community Acquired Pneumonia, COPD, Inflammatory Bowel Disease, Crohn, Colitis
- Medical subject headings
- Respiratory Tract Infections, Pneumonia, Bronchitis, Community-Acquired Pneumonia, Inflammatory Bowel Diseases, Pulmonary Disease, Chronic Obstructive, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled-ileocolonic-release nicotinamide (CICR-NAM): 500 mg/dDietary supplement
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): 1000 mg/dDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| 500 mg/d CICR-NAM | Active comparator | 500 mg/d controlled-ileocolonic-release nicotinamide for 28 d Receives: Dietary Supplement: Controlled-ileocolonic-release nicotinamide (CICR-NAM): 500 mg/d |
| 1000 mg/d CICR-NAM | Active comparator | 500 mg/d controlled-ileocolonic-release nicotinamide for 28 d Receives: Dietary Supplement: Controlled-ileocolonic-release nicotinamide (CICR-NAM): 1000 mg/d |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Simultaneous measurement by liquid chromatography with tandem mass spectrometry.
Measured: 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.
Measured: 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).
Measured: Weekly from baseline until week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start20 Apr 2024
- Primary completion20 May 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Infection (for Example, Pneumonia, Bronchitis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Schreiber, Prof. Dr. Dr. h.c., Principal investigator, University Hospital Schleswig-HolsteinJan Heyckendorf, Prof. Dr., Principal investigator, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156929
- Sponsor's protocol ID
- D 417/24
- Acronym
- CICR-NAM_PK
- Status last verified
- Sep 2025
- First submitted
- 28 Jul 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 40355744
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetics and Metabolism of Nicotinamide Provided as a Dietary Supplementation: CICR-NAM as Food for Special Medicinal Purposes (FSMP)
- ClinicalTrials.gov ID
- NCT07156929
- Acronym / sponsor ID
- CICR-NAM_PK / D 417/24
- Conditions
- Respiratory Infection (for Example, Pneumonia, Bronchitis), Respiratory Infection Virus, Community Acquired Pneumonia (CAP), COPD Acute Exacerbation, Inflammatory Bowel Disease (IBD)
- Keywords
- Nicotinamide, Controlled-Ileocolonic-Release Nicotinamide, CICR-NAM, Community Acquired Pneumonia, COPD, Inflammatory Bowel Disease, Crohn, Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 500 mg/d CICR-NAM | Active comparator | Dietary Supplement: Controlled-ileocolonic-release nicotinamide (CICR-NAM): 500 mg/d500 mg/d controlled-ileocolonic-release nicotinamide for 28 d |
| 1000 mg/d CICR-NAM | Active comparator | Dietary Supplement: Controlled-ileocolonic-release nicotinamide (CICR-NAM): 1000 mg/d500 mg/d controlled-ileocolonic-release nicotinamide for 28 d |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled-ileocolonic-release nicotinamide (CICR-NAM): 500 mg/dControlled-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 | 500 mg/d CICR-NAM |
| Controlled-ileocolonic-release nicotinamide (CICR-NAM): 1000 mg/dControlled-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 | 1000 mg/d CICR-NAM |
Primary outcome
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)
Time frame: From baseline (day 1) until day 2 (minimum), day 3 or day 8
Simultaneous measurement by liquid chromatography with tandem mass spectrometry.
3 secondary outcomes
Changes in serum concentrations of tryptophan and its metabolites
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)
Time frame: Weekly from baseline until week 4
Changes in fatigue (Functional Assessment of Chronic Illness Therapy - Fatigue [FACIT-F] questionnaire; optional)
Time frame: Weekly from baseline until week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Background: PubMed 40355744Schreiber 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Schreiber, Prof. Dr. Dr. h.c. principal investigator
University Hospital Schleswig-Holstein
Jan Heyckendorf, Prof. Dr. principal investigator
University Hospital Schleswig-Holstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Respiratory Infection (for Example, Pneumonia, Bronchitis) and Respiratory Infection Virus, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: From baseline (day 1) until day 2 (minimum), day 3 or day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07156929, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.