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RECRUITING
NCT07827989
NA

Study of the Impact of Phosphate Supplementation on FGF23 Concentrations in Patients With Hypophosphatemia

Sponsor: University Hospital, Clermont-Ferrand

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-06-13

Completion Date

2027-09

Last Updated

2026-09-18

Healthy Volunteers

No

Interventions

BIOLOGICAL

Blood sample

Collection of one EDTA tube for FGF23 measurement and one heparin tube for phosphorus measurement

Locations (3)

CHU Clermont-Ferrand Service de réanimation

Clermont-Ferrand, France

CHU Clermont-Ferrand Service Oncologie

Clermont-Ferrand, France

CHU Clermont-Ferrand Service Rhumatologie

Clermont-Ferrand, France