Observational Study With CICR-NAM as a Food for Special Medicinal Purposes in Post-COVID Syndrome (PCS) (CICR-NAM-PCS)
In patients with post-COVID syndrome, changes in tryptophan metabolism, energy metabolism, and the gut microbiome may occur. In an earlier nutritional study, patients with COVID-19 recovered their physical performance more quickly when taking nicotinamide (vitamin B3). Patients who responded to nicotinamide also developed post-COVID syndrome less frequently. At the University Hospital Schleswig-Holstein in Kiel, special nicotinamide tablets (CICR-NAM) were developed that release the active substance selectively in the lower intestine and have been shown to be very well tolerated in several studies.
Patients with post-COVID syndrome and documented tryptophan deficiency may therefore take one tablet (500 mg) of CICR-NAM daily for up to approximately 4 months as a food for special medicinal purposes within the therapy groups of the outpatient clinic for patients with post-COVID syndrome at the University Hospital Schleswig-Holstein in Kiel. This intake is far below the Upper Level defined by the European Food Safety Authority for lifelong daily intake (900 mg per day). Therefore, there are no safety concerns. CICR-NAM intake is intended to complement the therapy group programme by supporting energy metabolism.
調査の概要
詳細な説明
In the COVit-2 study (DRKS00021214), daily intake of two tablets containing a total of 1,000 mg nicotinamide (500 mg conventional nicotinamide and 500 mg controlled-ileocolonic-release nicotinamide, CICR-NAM) in patients with acute COVID-19 was associated with a significantly faster improvement in physical performance after two weeks compared with placebo. Parallel effects on the gut metagenome suggested that specifically the ileocolonically released nicotinamide from CICR-NAM tablets could counteract COVID-19-associated disturbances in the metabolism of the essential amino acid tryptophan and in the gut microbiome. In the placebo group, gene expression related to the microbial tryptophan biosynthesis pathway as well as redox and salvage pathways of the central metabolic coenzyme nicotinamide adenine dinucleotide (NAD+) was significantly increased at week 2, whereas these deviations in the metagenome were not observed in patients receiving nicotinamide supplementation.
At the 6-month follow-up of COVit-2 participants, patients who benefited from nicotinamide administration (responders) developed post-COVID syndrome significantly less frequently. Because disturbances in tryptophan metabolism are well described in both COVID-19 and PCS, a low tryptophan level may serve as an easily measurable surrogate parameter for an increased nicotinamide requirement in these conditions.
There is currently no satisfactory treatment for patients with PCS. They experience significant distress and often have a permanent disability. Given the disturbances in tryptophan metabolism and the gut microbiome observed in PCS, supplementation with CICR-NAM may help restore physical performance. Therefore, a nutritional observational study offering 500 mg/day CICR-NAM as a food for special medicinal purposes for up to approximately 4 months will be conducted within the therapy groups of the PCS outpatient clinic at UKSH Campus Kiel for patients with documented tryptophan deficiency. A placebo-controlled clinical trial with CICR-NAM in PCS is planned, but it will not be available for recruitment in the near future. The present observational study is intended as an interim option until the clinical trial begins and is also expected to provide insights into the feasibility of such an intervention.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Lennart Reinke, Dr. med.
- 電話番号：+49 431 500-22200
- メール：lennartmichel.reinke@uksh.de
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- all sexes;
- minimum age 18 years; no upper age limit;
- post-COVID syndrome (PCS)
- serum tryptophan <55 µmol/L (UKSH reference range: 48-109 µmol/L);
- participation in the therapy groups of the PCS outpatient clinic at UKSH Campus Kiel.
Exclusion Criteria:
- Known allergies or intolerances to any component of CICR-NAM;
- inability to provide informed consent;
- pregnancy or breastfeeding;
- severe comorbid disease (especially renal insufficiency, uncontrolled autoimmune diseases, liver disease, or malignancy);
- long-term use of higher doses of medications that raise gastric pH (for example proton pump inhibitors, H2 receptor antagonists, or antacids), as an increase in pH toward approximately 7 may cause premature release of nicotinamide from CICR-NAM;
- use of supplements containing more than 20 mg nicotinamide, nicotinamide riboside, nicotinamide mononucleotide, nicotinic acid, or NAD+ per daily dose.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：CICR-NAM Administration
Oral administration of CICR-NAM (controlled-ileocolonic-release nicotinamide) as a food for special medical purposes, one film-coated tablet (500 mg) daily for up to approximately 4 months, embedded in the therapy groups of the PCS outpatient clinic at UKSH Campus Kiel.
|
Oral administration of CICR-NAM (controlled-ileocolonic-release nicotinamide) as a food for special medical purposes, one film-coated tablet (500 mg) daily for up to approximately 4 months, embedded in the therapy groups of the PCS outpatient clinic at UKSH Campus Kiel
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serum tryptophan level
時間枠：From T1 (start of participation, screening for reduced serum tryptophan) to T6 (end of the therapy group) approximately 5 month.
|
Serum tryptophan level (µmol/L) as a longitudinal marker of tryptophan and NAD+ metabolism during CICR-NAM supplementation.
Assessment time points: therapy group session 1 (start of participation, screening for reduced serum tryptophan, T1), session 2 (start of supplementation, T2), session 3 (after approximately 1 month of supplementation, T3), and session 6 (end of the therapy group, after approximately 4 months, T4).
Method: quantitative determination of serum tryptophan (UKSH laboratory diagnostics)
|
From T1 (start of participation, screening for reduced serum tryptophan) to T6 (end of the therapy group) approximately 5 month.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- CICR-NAM-PCS_V01_2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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