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Recruiting NCT06845501

Purine Supplementation in Patients With AICA-Ribosiduria

No phase Interventional AICA-ribosiduria Due to ATIC Deficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: purine-rich diet.
Who it may be relevant to
Registry conditions: AICA-ribosiduria Due to ATIC Deficiency. Basic parameters: from 3 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

PURICA : Purine Supplementation in Patients With AICA-Ribosiduria

Overview

AICA-Ribosiduria due to ATIC deficiency is a rare genetic metabolic disease that affects less than 10 patients (PMID: 32557644). It results in severe polyhandicap linked to neurodevelopmental disorders, visual impairment, growth retardation, severe spinal deformities and scoliosis, and often early-onset epilepsy. The disease is caused by dysfunction of the ATIC enzyme, which is involved in de novo purine biosynthesis. A recent study (PMID: 38244287) reported a decrease in disease biomarkers in a single patient after 3 months on a purine-rich diet, which persisted for at least 1 year. The investigators propose to replicate this study on several patients to investigate the potential of this treatment for this severe orphan disease.

Interventions

  • Dietary supplement purine-rich diet
    diet to achieve a purine intake of 160mg/d

Primary outcome measures

  • Urinary concentration [Time frame: 6 months]
Secondary outcome measures (2)
  • Number of hospitalizations [Time frame: 12 months]
  • Quality of life score [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Individual affected by AICA-ribosiduria due to ATIC deficiency

Exclusion criteria

\- Individual already on a purine-rich diet theoretical contraindication to a purine-rich diet

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Chu Saint-Etienne — Saint-Etienne

Identifiers

NCT: NCT06845501 · 24CH171 · 2024-A02001-46

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗