| Trial ID: | L1190 |
| Source ID: | NCT02126293
|
| Associated Drug: |
Zinc Supplement
|
| Title: |
Correction of Zinc Deficiency in Children With Chronic Kidney Disease and Kidney Transplant
|
| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Renal Insufficiency, Chronic|Zinc Deficiency|Trace Element Excess|Trace Element Deficiency
|
| Interventions: |
DRUG: Zinc Supplement|PROCEDURE: Repeat blood and urine tests
|
| Outcome Measures: |
Primary: Establish proportion of zinc deficient children with chronic kidney disease and kidney transplant, who achieved correction of zinc deficiency after 3 months of zinc therapy, 3 months of therapy | Secondary: Change in parameters of bone metabolism following zinc treatment in zinc deficient patients, Correlations between various parameters of bone metabolism, kidney function, zinc, FGF-23 and Klotho assessed by a multiple regression model. Change from baseline in FGF-23, Klotho, TE levels and phosphate excretion after zinc therapy analyzed by a paired t-test., Baseline and 3 months|TE levels in zinc deficient children with chronic kidney disease and kidney transplant, Establish TE levels in zinc deficient children with chronic kidney disease and kidney transplant. Establish changes in TE levels following correction of zinc deficiency., Baseline and 12 weeks|TE levels in zinc sufficient children with chronic kidney disease and kidney transplant, Establish TE levels in zinc sufficient children with chronic kidney disease and kidney transplant. Establish TE levels 12 weeks later as a quality control measure., Baselne and 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Hamilton Health Sciences Corporation | Collaborators: London Health Sciences Centre
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
40
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2014-09
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| Completion Date: |
2017-01
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| Results First Posted: |
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| Last Update Posted: |
2017-03-13
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| Locations: |
McMaster Children's Hospital, Hamilton, Ontario, L8S 4K1, Canada|Children's Hospital, London Health Science Centre University of Western Ontario, London, Ontario, N6A 5W9, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT02126293
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