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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02218632 |
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Date of registration:
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07/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Glycosylation in Patients With Galactosaemia
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Scientific title:
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Galactosaemia, a Modifiable Multi-system Glycosylation Disorder? |
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Date of first enrolment:
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July 2012 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02218632 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Ireland
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Contacts
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Name:
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Eileen Treacy, MD, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Children's Hospital Dublin Irleland |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Classical galactosaemia
- Q188R Genotype
- On lactose-free diet
- No complications, condition well controlled
- Male/femal adults and children aged between 5-12 yrs.
- Informed consent /assent
- Patient attend the Galactosaemia Clinic, NCIMD Dublin
Exclusion Criteria:
- Complications, such as cataracts
- Galactosaemia varaint, no Q188R-Genotype
- Poor compliance
- Intercurrent illness
- Individual may not complete follow up
- Children below 5 years of age
- Unable to provide informed consent
- Patient not under the care of Galactosaemia Clinic, NCIMD Dublin
Age minimum:
5 Years
Age maximum:
40 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Classical Galactosaemia
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Intervention(s)
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Dietary Supplement: Temporary oral galactose supplements
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Other: lactose-free diet
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Primary Outcome(s)
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Number of patients with Classical Galactosaemia on a lactose-free diet in Ireland with disease specific complications
[Time Frame: 2 years]
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Secondary Outcome(s)
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Number of participants with Classical Galactosaemia with variations in their glycosylation status in the Irish cohort
[Time Frame: 2 years]
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Secondary ID(s)
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12020
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grant PAC number 12.64
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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