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NCT03748966 · ClinicalTrials.gov registry record · Early Phase 1
Calcitriol Monotherapy for X-Linked Hypophosphatemia
A Early Phase 1 study of X-linked Hypophosphatemia and Hypophosphatemic Rickets, X-Linked Dominant, sponsored by Massachusetts General Hospital.
- Active
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03748966: Active Early Phase 1 study of X-linked Hypophosphatemia and Hypophosphatemic Rickets, X-Linked Dominant, sponsored by Massachusetts General Hospital.
NCT03748966 is a Early Phase 1 study of X-linked Hypophosphatemia and Hypophosphatemic Rickets, X-Linked Dominant that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 20 participants, below the 170-participant average among 5 other X-linked Hypophosphatemia trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03748966, a Early Phase 1 study of X-linked Hypophosphatemia and Hypophosphatemic Rickets, X-Linked Dominant, is active but no longer recruiting, sponsored by Massachusetts General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Children and adults with XLH recruited will be treated with calcitriol alone (without phosphate supplementation) for one year, during which the calcitriol dose will be escalated during the first 3 months of therapy. The investigators hypothesize that treatment of adults and children with XLH alone will improve serum phosphate levels and skeletal mineralization without causing an increase in kidney calcifications. The study will also examine if calcitriol therapy will improve growth in children.
Primary Outcome
serum phosphate
Conditions Studied
Interventions
- DRUG Calcitriol
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-03-28 |
| Est. Completion | 2026-05 |
| Phase | Early Phase 1 |
What the registry record for NCT03748966 still lists
NCT03748966 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 170-participant average among 5 other X-linked Hypophosphatemia trials with a reported enrollment target (88% lower).
The record links to 3 conditions, with X-linked Hypophosphatemia appearing as the primary indexed condition, and to 1 intervention - of which Calcitriol is the first listed.
NCT03748966 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03748966 about?
NCT03748966 is a clinical study titled "Calcitriol Monotherapy for X-Linked Hypophosphatemia". Children and adults with XLH recruited will be treated with calcitriol alone (without phosphate supplementation) for one year, during which the calcitriol dose will be escalated during the first 3 months of therapy. The investigators hypothesize that treatment of adults and children with XLH alone w...
What is the current status of trial NCT03748966?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2019-03-28. Estimated completion is 2026-05.
What conditions does trial NCT03748966 study?
This clinical trial studies the following conditions: X-linked Hypophosphatemia, Hypophosphatemic Rickets, X-Linked Dominant, Hypophosphatemic Rickets.
What interventions are being tested in trial NCT03748966?
The interventions under investigation include: Calcitriol (DRUG).
Who is sponsoring clinical trial NCT03748966?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03748966 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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