Correction of Zinc Deficiency in Children With Chronic Kidney Disease and Kidney Transplant
Condition: Renal Insufficiency, Chronic; Zinc Deficiency; Trace Element Excess; Trace Element Deficiency
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
Study type: Interventional
Phase: Phase 3

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.
    


Intervention name(s): Zinc Supplement; Repeat blood and urine tests
Intervention type(s): Drug; Procedure
Other intervention name(s): Zinc Lozenges,Douglas Laboratories,HC NPN 80032476
Intervention MeSH terms: Zinc
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment