Status:
UNKNOWN
Vitamin B12 and Folinic Acid Supplementation in Mitochondrial DNA Deletion Syndromes
Lead Sponsor:
University of British Columbia
Conditions:
Mitochondrial DNA Deletion
Macrocytosis
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
The purpose of this single center study is to evaluate whether there is a concordant improvement in macrocytosis in patient with mtDNA deletions with established macrocytosis following a trial of Vita...
Detailed Description
Study Design: * Study type: Pilot single group study * Actual Enrollment: 25 participants * Allocation: N/A * Intervention Model: Single Group Assignment * Intervention Model Description: * Vitami...
Eligibility Criteria
Inclusion
- Ages eligible for study: 19 years and older (Adult, Older Adult)
- All subjects reviewed previously at the Adult Metabolic Diseases Clinic with clinical features characteristic of major mtDNA deletion cases with biochemical macrocytosis
- Continue prior administration of other therapies pertaining to their necessary medical care
- Subjects must be clinically stable for more than one month after any stroke-like episodes
- Written, informed consent to participate in the study
Exclusion
- Subjects with mitochondrial disease with a genetic etiology other than a major mtDNA deletion
- Palliative care patients
- Patients with a progressive neurologic disorder clinically attributable to a cause other than mitochondrial disease (e.g., ischemic stroke due to embolism from atrial fibrillation, atherosclerosis, malignant hypertension,)
- Subjects who decline blood test and/or the follow-up schedule
- Inability or refusal to give informed consent
- Coexisting participation with other investigational drug study
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06186154
Start Date
January 1 2024
End Date
March 1 2025
Last Update
December 29 2023
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