Clinical trial
Role of Vitamin E as an Adjuvant Therapy for Patients With Gaucher Disease Under Enzyme Replacement Therapy in Relation to Oxidative Stress
Name
FMASU MD72/2022
Description
gaucher disease (GD) can be classified into three clinical types .type 1,the most common type ,is the chronic non neuronpathic form of the disease,which shows gighly variable signs and symptoms and variable course,with visceral,skeletal and hematologic involvement among others.the neurologocal involvement can be observed in types 2 and 3
Trial arms
Trial start
2023-03-03
Estimated PCD
2023-09-05
Trial end
2023-10-05
Status
Completed
Phase
Early phase I
Treatment
Vitamin E
Vitamin E will be taken for 6 months for gaucher disease patients who have oxidative stress and vitamin E defecient
Arms:
cases who are taking vitamin E
Other names:
No other alternatives
Size
40
Primary endpoint
effect of vitamin E on oxidative stress and antioxidant markers in gaucher disease patients
6 months
Eligibility criteria
Inclusion Criteria:
children and adolescents aged fron 2 to 18 years old with gaucher disease both type 1 and type 3 diagnosed clinically and confirmed by laboratory analysis patients who are on stable enzyme replacement therapy for at least 6 months -
Exclusion Criteria:
patients with infection or another inflammatory condition patients on multivitamin therapy known chronic liver disease (viral hepatitis,HIV) patients with renal impairement defined as creatinine level greater 1.2 for female and greater than 1.4 for male.
-
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2024-01-18
1 organization
1 product
1 indication
Organization
Ain Shams UniversityProduct
Vitamin EIndication
Gaucher's Disease