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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Lise Laclautre
- Telefonnummer: 0473754963
- E-post: promo_interne_drci@chu-clermontferrand.fr
Studiesteder
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-
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Clermont-Ferrand, Frankrike
- Rekruttering
- CHU Clermont-Ferrand Service de réanimation
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Ta kontakt med:
- Lise Laclautre
- Telefonnummer: 0473754963
- E-post: promo_interne_drci@chu-clermontferrand.fr
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Hovedetterforsker:
- Laurent RENARD-TRICHE
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Clermont-Ferrand, Frankrike
- Rekruttering
- CHU Clermont-Ferrand Service Oncologie
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Hovedetterforsker:
- Aurore DOUGE
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Ta kontakt med:
- Lise Laclautre
- Telefonnummer: 0473754963
- E-post: promo_interne_drci@chu-clermontferrand.fr
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Clermont-Ferrand, Frankrike
- Rekruttering
- CHU Clermont-Ferrand Service Rhumatologie
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Ta kontakt med:
- Lise Laclautre
- Telefonnummer: 0473754963
- E-post: promo_interne_drci@chu-clermontferrand.fr
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Hovedetterforsker:
- Marie PICKERING
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Annen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Impact of phosphate supplementation on plasma FGF23 levels in acquired FGF23-independent hypophosphatemia
Tidsramme: 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
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Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Damien BOUVIER, CHU Clermont-Ferrand service de biochimie
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RBHP 2025 BOUVIER
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