Correction of Zinc Deficiency in Children With Chronic Kidney Disease and Kidney Transplant
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|ClinicalTrials.gov Identifier: NCT02126293|
Recruitment Status : Completed
First Posted : April 30, 2014
Last Update Posted : March 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Renal Insufficiency, Chronic Zinc Deficiency Trace Element Excess Trace Element Deficiency||Drug: Zinc Supplement Procedure: Repeat blood and urine tests||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Correction of Zinc Deficiency in Children With Chronic Kidney Disease and Kidney Transplant|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
Experimental: Zinc deficient patients
If the patient is found to be zinc deficient (serum zinc < 11.5 μmol/L), the family will be contacted by the RA to commence zinc supplement: zinc citrate (Zinc Lozenges, manufactured by Douglas Laboratories Inc, London, ON, Health Canada NPN 80032476) for 3 months. As per the NPN licence the dose is 10 mg (1 lozenge) orally once a day for children age 4-8 years, and 10 mg twice a day for children age 9-18 years. This should give enough time to restore serum zinc to normal in most patients.
Drug: Zinc Supplement
Other Name: Zinc Lozenges,Douglas Laboratories,HC NPN 80032476
Active Comparator: Zinc sufficient patients
Zinc sufficient patients will repeat blood and urine tests in 3 month time to compare the changes with intervention arm.
Procedure: Repeat blood and urine tests
- 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 [ Time Frame: 3 months of therapy ]
- Change in parameters of bone metabolism following zinc treatment in zinc deficient patients [ Time Frame: Baseline and 3 months ]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.
- TE levels in zinc deficient children with chronic kidney disease and kidney transplant [ Time Frame: Baseline and 12 weeks ]Establish TE levels in zinc deficient children with chronic kidney disease and kidney transplant. Establish changes in TE levels following correction of zinc deficiency.
- TE levels in zinc sufficient children with chronic kidney disease and kidney transplant [ Time Frame: Baselne and 12 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126293
|McMaster Children's Hospital|
|Hamilton, Ontario, Canada, L8S 4K1|
|Children's Hospital, London Health Science Centre University of Western Ontario|
|London, Ontario, Canada, N6A 5W9|
|Principal Investigator:||Vladimir Belostotsky, MD, PhD (eq)||Hamilton Health Sciences Corporation|