Chromium Contamination of Parenteral Nutrition
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?
1 other identifier
observational
75
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 25, 2018
CompletedFirst Submitted
Initial submission to the registry
March 21, 2019
CompletedFirst Posted
Study publicly available on registry
April 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedJune 4, 2020
June 1, 2020
1.6 years
March 21, 2019
June 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Trace elements concentrtion in TPN
trace elements concentration will be measured in TPN solution using ICP-MS
18 months
Eligibility Criteria
Patients who are on TPN and are "inpatients at Sickkids" or outpatients on Home TPN.
You may qualify if:
- All patients on TPN followed by Sickkids
You may not qualify if:
- Patients not on TPN
- Patients not interested in participating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Glenda Courtney-Martin, PhD, RD
The Hospital for Sick Children
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Scientist
Study Record Dates
First Submitted
March 21, 2019
First Posted
April 8, 2019
Study Start
February 25, 2018
Primary Completion
September 30, 2019
Study Completion
September 30, 2019
Last Updated
June 4, 2020
Record last verified: 2020-06