Status:
UNKNOWN
Using Different Doses of Active Vitamin D Combined With Neutral Phosphate in Children With X-linked Hypophosphatemia
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
X-linked Hypophosphatemia
Eligibility:
All Genders
1-12 years
Phase:
PHASE4
Brief Summary
X-linked hypophosphatemia (XLH) is the most common form of heritable rickets. Current treatments include active vitamin D metabolites (e.g. calcitriol) and phosphate salts. There is no consistent weig...
Eligibility Criteria
Inclusion
- Male or female, aged 1-12 years, inclusive
- Diagnosis of XLH by clinical features: serum phosphorus level \< 2.5 mg/dl; ALP?; RSS total score ≥2; bowed legs; short stature; family history with appropriate X-linked inheritance
- Meet at least one of the following: confirmed Phosphate regulating gene with homology to endopeptidases located on the X chromosome (PHEX) mutation in the participant, or serum FGF23 level \>30 pg/ml (Kainos assay)
- Willing to participate the study, and provide an informed consent
- Able to complete all aspects of study and adhere to the visit schedule
Exclusion
- Use of growth hormone within 12 months before first visit
- Height \>50 percentile for age and sex specific data
- Presence of nephrocalcinosis or nephrolithiasis
- Serum intact parathyroid hormone level\>170 pg/ml
- Plan to receive orthopaedic surgery in 12 months
- Poor compliance
- Use of gonadotropin-releasing hormone therapy right now
- Use of aluminium hydroxide, steroid, acetazolamide or thiazide drugs within 7 days before first visit
- Not be fit to participant in the study, by the judgement of investigators
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03820518
Start Date
January 1 2017
End Date
December 31 2022
Last Update
January 30 2019
Active Locations (1)
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1
Department of Endocrinology, Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730