Kinetics and Metabolism of Nicotinamide Provided as a Dietary Supplementation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-20

Study Completion Date

2025-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Respiratory Infection (for Example, Pneumonia, Bronchitis) Respiratory Infection Virus Community Acquired Pneumonia (CAP) COPD Acute Exacerbation Inflammatory Bowel Disease (IBD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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500 mg/d CICR-NAM

500 mg/d controlled-ileocolonic-release nicotinamide for 28 d

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

1000 mg/d CICR-NAM

500 mg/d controlled-ileocolonic-release nicotinamide for 28 d

Group Type ACTIVE_COMPARATOR

Controlled-ileocolonic-release nicotinamide (CICR-NAM): 1000 mg/d

Intervention Type 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.

Interventions

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Controlled-ileocolonic-release nicotinamide (CICR-NAM): 500 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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No