NCT04987073

Brief Summary

Preclinical evaluation of a vitamin D analog for the treatment of vitamin D 24-hydroxylase using fibroblast from patients with CYP24A1 mutation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jul 2022Jul 2027

First Submitted

Initial submission to the registry

July 22, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

July 17, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

4 years

First QC Date

July 22, 2021

Last Update Submit

July 22, 2025

Conditions

Idiopathic Infantile Hypercalcemia - Severe Form

Keywords

CYP24A1vitamin D

Outcome Measures

Primary Outcomes (1)

  • Effects of the analog on vitamin D induced genes' expression

    RNA quantification of genes induced by vitamin D in presence of analog in patients' fibroblast

    3 years

Study Arms (1)

patients with CYP24A1 mutation

EXPERIMENTAL
Procedure: skin biopsy

Interventions

skin biopsyPROCEDURE

A skin biopsy to cultivate fibroblasts.

patients with CYP24A1 mutation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • biallelic mutation in CYP24A1
  • consent

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arnaud Molin

Caen, Normandy, 14033, France

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2021

First Posted

August 3, 2021

Study Start

July 17, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

July 25, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)