Study of the Impact of Phosphate Supplementation on FGF23 Concentrations in Patients With Hypophosphatemia (PHOSPHO-23)
Fibroblast growth factor 23 (FGF23) is the principal hormone regulating serum phosphate homeostasis. Secreted by osteocytes, it promotes renal phosphate excretion and suppresses the synthesis of 1,25-dihydroxyvitamin D. Measurement of FGF23 has become a key tool in the evaluation of hypophosphatemia, allowing distinction between FGF23-dependent forms (such as X-linked hypophosphatemic rickets, tumor-induced osteomalacia, and intravenous iron-induced hypophosphatemia) and FGF23-independent forms (including renal, gastrointestinal, nutritional, or drug-related causes).
In healthy adults, several studies have demonstrated that FGF23 levels vary according to phosphate intake, decreasing during dietary restriction and increasing following phosphate loading. In hypophosphatemic conditions, however, available data are limited to X-linked hypophosphatemic rickets, where prolonged supplementation with phosphate and calcitriol leads to increased FGF23 levels, consistent with the underlying pathophysiology.
Based on these observations, it is currently recommended, as a precaution, to measure FGF23 at least 15 days after discontinuation of phosphate supplementation in order to avoid transient elevations that may confound interpretation. In practice, however, this recommendation is difficult to implement, as most patients are already receiving phosphate supplementation at the time of evaluation.
To date, no study has specifically assessed the effect of phosphate supplementation in patients with FGF23-independent hypophosphatemia, a condition characterized by appropriately low FGF23 levels. It therefore remains unclear whether supplementation could induce a transient rise in circulating FGF23, potentially leading to misclassification as FGF23-dependent hypophosphatemia (FGF23 > 95 ng/L).
This uncertainty provides a strong rationale for conducting the present study.
調査の概要
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：Lise Laclautre
- 電話番号：0473754963
- メール：promo_interne_drci@chu-clermontferrand.fr
研究場所
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-
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Clermont-Ferrand、フランス
- 募集
- CHU Clermont-Ferrand Service de réanimation
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コンタクト：
- Lise Laclautre
- 電話番号：0473754963
- メール：promo_interne_drci@chu-clermontferrand.fr
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主任研究者：
- Laurent RENARD-TRICHE
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Clermont-Ferrand、フランス
- 募集
- CHU Clermont-Ferrand Service Oncologie
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主任研究者：
- Aurore DOUGE
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コンタクト：
- Lise Laclautre
- 電話番号：0473754963
- メール：promo_interne_drci@chu-clermontferrand.fr
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Clermont-Ferrand、フランス
- 募集
- CHU Clermont-Ferrand Service Rhumatologie
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コンタクト：
- Lise Laclautre
- 電話番号：0473754963
- メール：promo_interne_drci@chu-clermontferrand.fr
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主任研究者：
- Marie PICKERING
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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:
- Patients hospitalized in adult intensive care, oncology, or rheumatology
- Hypophosphatemia < 0.8 mmol/L
- Clinical indication for phosphate supplementation
Exclusion Criteria:
- Chronic kidney disease, stage ≥ 3 (eGFR < 60 mL/min/1.73 m²)
- Treatment with Ferinject® within the past year
- Sepsis
- Current treatment with active vitamin D
- Pregnancy or breastfeeding
- Inability to perform blood draws due to insufficient venous access
- Weight < 35 kg (for intensive care patients only)
- Hypercalcemia > 2.6 mmol/L
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：他の
- 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 |
|---|---|
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他の：Patients hospitalized in adult intensive care, oncology, or rheumatology
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Collection of one EDTA tube for FGF23 measurement and one heparin tube for phosphorus measurement
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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 |
|---|---|---|
|
Impact of phosphate supplementation on plasma FGF23 levels in acquired FGF23-independent hypophosphatemia
時間枠：Up to 21 days
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To determine whether phosphate supplementation modifies plasma FGF23 concentrations in patients with acquired FGF23-independent hypophosphatemia by studying changes in FGF23 concentrations following phosphate supplementation. The primary objective will be studied separately in two groups: first, in intensive care patients, and second, in oncology/rheumatology patients. |
Up to 21 days
|
協力者と研究者
捜査官
- スタディチェア：Damien BOUVIER、CHU Clermont-Ferrand service de biochimie
研究記録日
主要日程の研究
研究開始 (実際)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。