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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Lise Laclautre
- Telefonnummer: 0473754963
- E-post: promo_interne_drci@chu-clermontferrand.fr
Studieorter
-
-
-
Clermont-Ferrand, Frankrike
- Rekrytering
- CHU Clermont-Ferrand Service de réanimation
-
Kontakt:
- Lise Laclautre
- Telefonnummer: 0473754963
- E-post: promo_interne_drci@chu-clermontferrand.fr
-
Huvudutredare:
- Laurent RENARD-TRICHE
-
Clermont-Ferrand, Frankrike
- Rekrytering
- CHU Clermont-Ferrand Service Oncologie
-
Huvudutredare:
- Aurore DOUGE
-
Kontakt:
- Lise Laclautre
- Telefonnummer: 0473754963
- E-post: promo_interne_drci@chu-clermontferrand.fr
-
Clermont-Ferrand, Frankrike
- Rekrytering
- CHU Clermont-Ferrand Service Rhumatologie
-
Kontakt:
- Lise Laclautre
- Telefonnummer: 0473754963
- E-post: promo_interne_drci@chu-clermontferrand.fr
-
Huvudutredare:
- Marie PICKERING
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: Patients hospitalized in adult intensive care, oncology, or rheumatology
|
Collection of one EDTA tube for FGF23 measurement and one heparin tube for phosphorus measurement
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Impact of phosphate supplementation on plasma FGF23 levels in acquired FGF23-independent hypophosphatemia
Tidsram: Up to 21 days
|
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
|
Samarbetspartners och utredare
Utredare
- Studiestol: Damien BOUVIER, CHU Clermont-Ferrand service de biochimie
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RBHP 2025 BOUVIER
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .