levels of the hormone FGF23 in healthy volunteers with a low phosphate level

Phase 1

• Conditions: healthy volunteersthe information of this pilot study will be used in the care of patients with hypophosphatemia due to renal phosphate wasting; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2016-002602-39-NL
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-18
• Last Update Posted: 19 September 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

age older than 18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

any medical history
inability to give informed consent
pregnancy
medication use (except from oral contraceptives)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to determine if serum FGF23 levels are affected by hypophospatemia;Secondary Objective: not applicable;Primary end point(s): serum levels of FGF23 and serum phosphate;Timepoint(s) of evaluation of this end point: monday, tuesday, wednesday, thursday, friday

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): serum calcium, PTH, 1.25OHD, 25OHD, FePi;Timepoint(s) of evaluation of this end point: monday, tuesday, wednesday, thursday, friday