Trace Element Excess Clinical Trial
Official title:
Chromium and Trace Element Content (Cobalt, Copper, Manganese, Molybdenum, Selenium, Vanadium, Zinc) of Pediatric Parenteral Nutrition Solutions in Canada: Are Pediatric Patients on Parenteral Nutrition Exposed to Toxic Amounts?
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.
Intestinal Failure (IF) occurs when a person's gut cannot work well enough to absorb enough
nutrients and fluids. In these cases, life-saving nutrition called Parenteral Nutrition (PN)
is given through their veins for months or years. Unfortunately, tubes of certain nutrients
that are added to PN solutions have contaminants such as chromium (Cr). While the body needs
a very small amount of Cr to function properly, too much is unsafe. Patients on PN may
therefore get too much Cr in the PN fluids. Too much Cr can affect kidndy function. In
addition to chromium, it is also possible that other trace elements are present as
contaminants. While optimal nutrition if important for growth in children, too much of any
nutriteint is potenially harmful. The goals of the current study therefore are
1. Measure and compare the amount of chromium, cobalt, copper, manganese, molybdenum,
selenium, vanadium and zinc in a sample of discarded PN bags versus the amount of each
actually ordered in those PN bags to determine the level of contamination for each of
those trace elements.
2. Compare the total delivered amounts of the above elements to the current recommended
amounts for age.
3. To determine if in fact patients are receiving greater than recommended amounts of
chromium and other trace elements so that decisions can be made regarding current
practice at SickKids.
4. To obtain small volumePN solutions from a PN supplier for analysis of each of the above
mentioned trac elements for comparios what the information listed on the label of each
of those products.
5. To retrospecitvely review the charts of patients who consented to have their PN analyzed
from goal #1 and record blood chromium levels done over the last 5 yrs (Jan 1/2013 - Nov
30/2018) as well as Cr content of their PN solutions at the time blood Cr levels were
recorded.
All patients on PN at Sickkids were eligible to participate. Data will be collected on
patients weight, age, date of birth, and PN order as well as blood levels of Cr of home PN
patients for the retrspective portion of the study.
Samples will be analyzed at London Health Science Centre in their Trace Elements laboratory
using a Thermo Fisher ELEMENT 2 "High Resolution Sector Field Inductively Coupled Plasma Mass
Spectrometer" (HR-SF-ICP-MS). This analyzer is considered the Gold Standard of
Instrumentation. Samples are assessed against NIST Traceable Standards accompanying
Commercial Controls to maintain as high a degree of accuracy as possible. The report of
analysis will be sent to the Principal Investigator of the study.
Statistics:
Statistical analysis will be performed on primary and derived variables using SAS. Student's
t-test will be used to compare the amount of teh trace elements in the PN compared to what
has been ordered. Trace elements recieved pre kg/body weight will abls be compared to the
recommended amount by ASPEN.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02126293 -
Correction of Zinc Deficiency in Children With Chronic Kidney Disease and Kidney Transplant
|
Phase 3 |