Using Different Doses of Active Vitamin D Combined With Neutral Phosphate in Children With X-linked Hypophosphatemia
NCT ID: NCT03820518
Last Updated: 2019-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2017-01-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High-dose
Receiving 60 ng/kg/day of calcitriol and 30 mg/kg/day of elemental phosphorus.
Calcitriol
Low-dose
Receiving 20 ng/kg/day of calcitriol and 30 mg/kg/day of elemental phosphorus.
Calcitriol
Interventions
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Calcitriol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
1 Year
12 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Locations
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Department of Endocrinology, Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JS-1824
Identifier Type: -
Identifier Source: org_study_id
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