Status:
COMPLETED
Modified Ketogenic Diet in Patients With McArdle Disease Part B
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
University College, London
Conditions:
McArdle Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
McArdle disease, glycogen storage disease type V, is a rare metabolic disease. Affected individuals are unable to utilize sugar stored as glycogen in muscle. Investigators hypothesize that a modified ...
Detailed Description
A blinded randomized, placebo-controlled, cross-over study to investigate the effects of a modified ketogenic diet in patients with McArdle disease. McArdle disease, glycogen storage disease type V, ...
Eligibility Criteria
Inclusion
- Genetically confirmed GSDV
- Patient is willing and able to provide written informed consent prior to participation.
- Patient is ambulatory.
- Women in fertile age must be willing to practice the following medically acceptable methods of birth control
Exclusion
- Patient has any prior or current medical conditions that, in the judgment of the Investigator, would prevent the patient from safely participating in and/or completing all study requirements.
- Pregnancy or breastfeeding
- Patient does not have the cognitive capacity to understand/comprehend and complete all study assessments
- Patients with porphyria or disorders of fat metabolism (primary carnitine deficiency, carnitine palmitoyltransferase I or II, β-oxidation defects etc.).
Key Trial Info
Start Date :
August 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04044508
Start Date
August 3 2019
End Date
December 1 2022
Last Update
February 13 2023
Active Locations (2)
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1
Copenhagen Neuromuscular Center, Rigshospitalet
Copenhagen, Denmark
2
National Hospital for Neurology and neurosurgery
London, United Kingdom