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NCT Number: NCT07156929

Kinetics and Metabolism of Nicotinamide Provided as a Dietary Supplementation

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.

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Key information

Conditions

Respiratory Infection (for Example, Pneumonia, Bronchitis) Bronchial Diseases Bronchitis COPD Acute Exacerbation Chronic Disease Colitis Colonic Diseases Community Acquired Pneumonia (CAP) Community-Acquired Infections Community-Acquired Pneumonia Digestive System Diseases Disease Attributes Gastroenteritis Gastrointestinal Diseases Infections Inflammatory Bowel Disease (IBD) Inflammatory Bowel Diseases Intestinal Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pulmonary Disease, Chronic Obstructive Respiratory Infection Virus Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Controlled-ileocolonic-release nicotinamide (CICR-NAM): 500 mg/d

Dietary 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/d

Dietary 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.

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)

    Time frame: From baseline (day 1) until day 2 (minimum), day 3 or day 8

    Simultaneous measurement by liquid chromatography with tandem mass spectrometry.

Secondary outcomes

  1. Changes in serum concentrations of tryptophan and its metabolites

    Time frame: From baseline (day 1) until day 2 (minimum), day 3 or day 8

    Simultaneous measurement by liquid chromatography with tandem mass spectrometry.

  2. Changes in quality of life (EuroQoL 5 Dimensions 5 Levels [EQ-5D-5L] questionnaire; optional)

    Time frame: Weekly from baseline until week 4

    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.

  3. Changes in fatigue (Functional Assessment of Chronic Illness Therapy - Fatigue [FACIT-F] questionnaire; optional)

    Time frame: Weekly from baseline until week 4

    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).

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study title

Kinetics and Metabolism of Nicotinamide Provided as a Dietary Supplementation: CICR-NAM as Food for Special Medicinal Purposes (FSMP)

Acronym: CICR-NAM_PK

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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