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?
Verified date | June 2020 |
Source | The Hospital for Sick Children |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
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.
Status | Completed |
Enrollment | 75 |
Est. completion date | September 30, 2019 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility |
Inclusion Criteria: - All patients on TPN followed by Sickkids Exclusion Criteria: - Patients not on TPN - Patients not interested in participating. |
Country | Name | City | State |
---|---|---|---|
Canada | The Hospital for Sick Children | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children | Rare Disease Foundation Microgrant competition |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Trace elements concentrtion in TPN | trace elements concentration will be measured in TPN solution using ICP-MS | 18 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02126293 -
Correction of Zinc Deficiency in Children With Chronic Kidney Disease and Kidney Transplant
|
Phase 3 |