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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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10 August 2015 |
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Main ID: |
NCT00104494 |
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Date of registration:
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01/03/2005 |
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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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Zinc Homeostasis and Kinetics in Children With Cystic Fibrosis (CF)
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Scientific title:
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Zinc Homeostasis and Kinetics in Children With CF |
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Date of first enrolment:
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May 2004 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00104494 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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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United States
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Contacts
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Name:
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Ian J Griffin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Baylor College of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Aged 8-14 years old
- Have clinical pancreatic insufficiency (defined as the need for pancreatic enzyme
replacement)
- Have no other medical problems except CF (and its complications)
- Weigh > 25kg
Exclusion Criteria:
- Are taking any medicines (other than for CF and its complications)
- Have known pancreatic endocrine dysfunction
- Are taking more than 10 mg/d elemental zinc supplements
- Have had major GI surgery, including gut resection, but not including surgery for
decompression of meconium ileus (if this was the presenting feature of CF)
Age minimum:
8 Years
Age maximum:
14 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Zinc acetate (20mg/d)
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Primary Outcome(s)
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Zinc balance
[Time Frame: 120h]
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Secondary Outcome(s)
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Serum ferritin
[Time Frame: 8wk]
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Serum ceruloplasmin
[Time Frame: 8wk]
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Serum copper
[Time Frame: 8wk]
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Secondary ID(s)
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GRIFFI04A0
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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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