Evaluation of the Effects of Calcitriol's in the Neurological Symptoms of Friedreich's Ataxia Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

August 25, 2021

Primary Completion Date

September 30, 2022

Study Completion Date

January 31, 2023

Conditions
Friedreich Ataxia
Interventions
DRUG

Calcitriol

Administration of Calcitrol 0.25mcg/24h for a year in Friedreich's Ataxia patients (n=20)

OTHER

Blood analysis for frataxin's level measurement

"1. Five blood analysis in Friedreich's Ataxia patients: before starting the treatment, and after fifteen days, 4 months, 8 months and 12 months of the treatment.~2. To validate the Frataxin's levels measurement, a blood analysis will also be done in two kind of controls for every Friedreich's Ataxia patient, only once at the beginning of the trial.~The control groups will be composed by:~* Heterozygous Ataxia's Friedreich controls (a close relative of the patient, either a heterozygous sibling or one of the parents)~* Age- and gender-matched controls (supposedly non-heterozygous)."

DIAGNOSTIC_TEST

Blood analysis for hypercalcemia's control

Five blood analysis in Friedreich's Ataxia patients for monitoring the hypercalcemia risk (with measurement of Calcium, D Vitamin, renal function, albumin, protein, phosphate, sodium and potassium) Before starting the treatment, and after fifteen days, at 4 months, 8 months and 12 months of the treatment.

Trial Locations (1)

17190

Hospital Santa Caterina/Parc Martí i Julià, Salt

All Listed Sponsors
collaborator

Institut de Recerca Biomèdica de Lleida

OTHER

collaborator

Universitat de Lleida

OTHER

collaborator

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

OTHER

lead

Berta Alemany

OTHER

NCT04801303 - Evaluation of the Effects of Calcitriol's in the Neurological Symptoms of Friedreich's Ataxia Patients | Biotech Hunter | Biotech Hunter