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Correction of Zinc Deficiency in Children With Chronic Kidney Disease and Kidney Transplant

Primary Purpose

Renal Insufficiency, Chronic, Zinc Deficiency, Trace Element Excess

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Zinc Supplement
Repeat blood and urine tests
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Insufficiency, Chronic

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children between 4 and 18 years of age; diagnosis of CKD; renal transplant recipient with declining renal function (eGFR<90 ml/min/1.73 m2).

Exclusion Criteria:

  • Children with CKD or kidney transplant younger than 4 years. Kidney transplant recipients with eGFR>90 ml/min/1.73 m2.

Sites / Locations

  • McMaster Children's Hospital
  • Children's Hospital, London Health Science Centre University of Western Ontario

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Zinc deficient patients

Zinc sufficient patients

Arm Description

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.

Zinc sufficient patients will repeat blood and urine tests in 3 month time to compare the changes with intervention arm.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 30, 2014
Last Updated
March 10, 2017
Sponsor
Hamilton Health Sciences Corporation
Collaborators
London Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02126293
Brief Title
Correction of Zinc Deficiency in Children With Chronic Kidney Disease and Kidney Transplant
Official Title
Correction of Zinc Deficiency in Children With Chronic Kidney Disease and Kidney Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
London Health Sciences Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Children with chronic kidney disease, even after transplantation, may be at risk for bone problems due to an imbalance of calcium and phosphorus in the blood, especially as their kidneys progressively fail to function. While some drug and diet treatments are available to prevent such bone disease, many children refuse to take them due to bad taste and tummy cramps. If calcium and phosphorus status remain abnormal for a long time, hard crystals can form in the blood vessels, eventually clogging them and resulting in heart problems. Investigators are studying possible new methods to help the kidneys maintain a normal balance of nutrients in the blood which is important for growing healthy bones and the prevention of side effects in blood vessels that can lead to heart disease. One method is to improve the team work of a hormone FGF-23 and a protein called Klotho that together stimulate the kidneys to increase phosphate removal. Investigators propose that this problem may be due to low blood zinc levels which often occur in children with kidney disease. Thus, in this study, investigators propose to first measure zinc in blood from children with chronic kidney disease (CKD) or who have had kidney transplants to assess zinc and phosphate status, the hormone FGF-23 and its assistant Klotho. If zinc status is low, the children will receive zinc supplementation for 3 months. After treatment with zinc, the same blood measurements will be repeated to determine if the zinc supplements have helped the hormones to remove phosphate from the body. If this pilot project is successful, investigators will then consider a larger scale project involving adult patients as well as pediatric patients from other pediatric centers. This project will also guide investigators as to whether they need to introduce zinc measurements as part of routine testing of CKD and transplant patients. In addition to measuring zinc levels in study participants, trace elements (TE) will also be measured. These include heavy metals such as cadmium, chromium, nickel, vanadium, copper, lead, manganese and selenium. Very little is known about levels and metabolism of TE in CKD especially before dialysis. In adults, cadmium, chromium, nickel, and vanadium probably accumulate in hemodialysis patients, while copper and lead may accumulate. Manganese, selenium are probably deficient. The study will allow investigators to obtain the information about TE in this group of pediatric patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic, Zinc Deficiency, Trace Element Excess, Trace Element Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zinc deficient patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Zinc sufficient patients
Arm Type
Active Comparator
Arm Description
Zinc sufficient patients will repeat blood and urine tests in 3 month time to compare the changes with intervention arm.
Intervention Type
Drug
Intervention Name(s)
Zinc Supplement
Other Intervention Name(s)
Zinc Lozenges,Douglas Laboratories,HC NPN 80032476
Intervention Type
Procedure
Intervention Name(s)
Repeat blood and urine tests
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change in parameters of bone metabolism following zinc treatment in zinc deficient patients
Description
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.
Time Frame
Baseline and 3 months
Title
TE levels in zinc deficient children with chronic kidney disease and kidney transplant
Description
Establish TE levels in zinc deficient children with chronic kidney disease and kidney transplant. Establish changes in TE levels following correction of zinc deficiency.
Time Frame
Baseline and 12 weeks
Title
TE levels in zinc sufficient children with chronic kidney disease and kidney transplant
Description
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.
Time Frame
Baselne and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children between 4 and 18 years of age; diagnosis of CKD; renal transplant recipient with declining renal function (eGFR<90 ml/min/1.73 m2). Exclusion Criteria: Children with CKD or kidney transplant younger than 4 years. Kidney transplant recipients with eGFR>90 ml/min/1.73 m2.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Belostotsky, MD, PhD (eq)
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Facility Name
Children's Hospital, London Health Science Centre University of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29992019
Citation
Filler G, Taheri S, McIntyre C, Smith C, Subramanian L, Fusch G, Fusch C. Chronic kidney disease stage affects small, dense low-density lipoprotein but not glycated low-density lipoprotein in younger chronic kidney disease patients: a cross-sectional study. Clin Kidney J. 2018 Jun;11(3):383-388. doi: 10.1093/ckj/sfx115. Epub 2017 Oct 12.
Results Reference
derived
PubMed Identifier
28592575
Citation
Filler G, Kobrzynski M, Sidhu HK, Belostotsky V, Huang SS, McIntyre C, Yang L. A cross-sectional study measuring vanadium and chromium levels in paediatric patients with CKD. BMJ Open. 2017 Jun 6;7(5):e014821. doi: 10.1136/bmjopen-2016-014821.
Results Reference
derived

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Correction of Zinc Deficiency in Children With Chronic Kidney Disease and Kidney Transplant

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