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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
Sponsor:
Collaborator:
London Health Sciences Centre
Information provided by (Responsible Party):
Hamilton Health Sciences Corporation

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
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
Sponsors and Collaborators
Hamilton Health Sciences Corporation
London Health Sciences Centre
Investigators
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Principal Investigator: Vladimir Belostotsky, MD, PhD (eq) Hamilton Health Sciences Corporation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT02126293     History of Changes
Other Study ID Numbers: ZICKD13-827
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
Zinc
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs