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临床试验/NCT02126293
NCT02126293已完成3 期

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

Hamilton Health Sciences Corporation2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
40
试验地点
2
主要终点
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

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
4 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

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

研究组 & 干预措施

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.

干预措施: Zinc Supplement (Drug)

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.

干预措施: Repeat blood and urine tests (Procedure)

结局指标

主要结局

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

时间窗: 3 months of therapy

次要结局

  • TE levels in zinc deficient children with chronic kidney disease and kidney transplant(Baseline and 12 weeks)
  • Change in parameters of bone metabolism following zinc treatment in zinc deficient patients(Baseline and 3 months)
  • TE levels in zinc sufficient children with chronic kidney disease and kidney transplant(Baselne and 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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