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

NCT02126293 | Completed Phase 3

• 1 other identifier: ZICKD13-827
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Renal Insufficiency, Chronic; Zinc Deficiency; Trace Element Excess; Trace Element Deficiency

Outcome Measures

Primary Outcomes (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

  3 months of therapy

Secondary Outcomes (3)

• Change in parameters of bone metabolism following zinc treatment in zinc deficient patients

  Baseline and 3 months

• TE levels in zinc deficient children with chronic kidney disease and kidney transplant

  Baseline and 12 weeks

• TE levels in zinc sufficient children with chronic kidney disease and kidney transplant

  Baselne and 12 weeks

Study Arms (2)

Zinc deficient patients

EXPERIMENTAL

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

Zinc sufficient patients

ACTIVE COMPARATOR

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

Interventions

Zinc Supplement DRUG

Also known as: Zinc Lozenges,Douglas Laboratories,HC NPN 80032476

Zinc deficient patients

Repeat blood and urine tests PROCEDURE

Zinc sufficient patients

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• London Health Sciences Centre: collaborator

Study Sites (2)

McMaster Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

Location

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

London, Ontario, N6A 5W9, Canada

Location

Related Publications (2)

• 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.

  PMID: 29992019 DERIVED

• 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.

  PMID: 28592575 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Urinalysis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Investigative Techniques

Study Officials

• Vladimir Belostotsky, MD, PhD (eq)

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: April 30, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: March 13, 2017

Record last verified: 2017-03

Locations

CA (2)