Trace Element ExcessNCT03906890
Chromium Contamination of Parenteral Nutrition
An observational study of Trace Element Excess, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Trace Element Excess
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 25 Feb 2018to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients who are on TPN and are "inpatients at Sickkids" or outpatients on Home TPN.
Who may be able to join
- All patients on TPN followed by Sickkids
Who cannot join
- Patients not on TPN
- Patients not interested in participating.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- 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.
- 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.
Read the detailed description
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
- 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.
- Compare the total delivered amounts of the above elements to the current recommended amounts for age.
- 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.
- 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.
- 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.
- Conditions
- Trace Element Excess
What is being measured
The primary outcome is the main question the study is designed to answer.
Trace elements concentrtion in TPN
trace elements concentration will be measured in TPN solution using ICP-MS
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start25 Feb 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trace Element ExcessStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Rare Disease Foundation Microgrant competition
- Responsible party
- Principal investigator, Glenda Courtney-Martin, The Hospital for Sick Children
- Investigators
- Glenda Courtney-Martin, PhD, RD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906890
- Sponsor's protocol ID
- 1000057101
- Status last verified
- Jun 2020
- First submitted
- 21 Mar 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT03906890
- Acronym / sponsor ID
- 1000057101
- Conditions
- Trace Element Excess
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Rare Disease Foundation Microgrant competition
- Study start
- 25 Feb 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
Detailed description
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
- 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.
- Compare the total delivered amounts of the above elements to the current recommended amounts for age.
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who are on TPN and are "inpatients at Sickkids" or outpatients on Home TPN.
Key inclusion criteria (1 listed)
- All patients on TPN followed by Sickkids
Key exclusion criteria (2 listed)
- Patients not on TPN
- Patients not interested in participating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Trace elements concentrtion in TPN
Time frame: 18 months
trace elements concentration will be measured in TPN solution using ICP-MS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenda Courtney-Martin, PhD, RD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trace Element Excess, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trace elements concentrtion in TPN (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.