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Trace Element Excess clinical trials

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NCT ID: NCT03906890 Completed - Clinical trials for Trace Element Excess

Chromium Contamination of Parenteral Nutrition

Start date: February 25, 2018
Phase:
Study type: Observational

It has been observed that patients on total parenteral nutrition (TPN) have high plasma chromium level. There is reason to believe that TPN solutions contain chromium and possibly other trace elements as contaminants. Chromium in particular can lead to kidney damage. The purpose of this research are 1). to collect discarded TPN samples from patients on TPN for analysis and compare analyzed concnetrations of trace elements to prescribed concentrations. 2) analyze small volume parenterals obtained from a TPN supplier for evaluation of trace elements contcentrations to be compared with what is reported on the label. 3) retrospectively collect blood levels of chromium from charts of patients on home TPN who consented to have their TPN samples analyzed (#1 above), as well as prescribed Cr in their TPN at the time blood levels are recorded.

NCT ID: NCT02126293 Completed - Clinical trials for Renal Insufficiency, Chronic

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

Start date: September 2014
Phase: Phase 3
Study type: Interventional

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.