Kinetics and Metabolism of Nicotinamide Provided as a Dietary Supplementation: CICR-NAM as Food for Special Medicinal Purposes (FSMP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- 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)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
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)
时间窗: From baseline (day 1) until day 2 (minimum), day 3 or day 8
Simultaneous measurement by liquid chromatography with tandem mass spectrometry.
次要结局
- 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)