Aluminum Contamination of Parenteral NutritionNCT01371123
Serum Aluminum Concentration of Pediatric Patients Receiving Long-Term Parenteral Nutrition
An observational study of Aluminum Contamination of Parenteral Nutrition, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether children on long-term parenteral nutrition (>6 weeks) have serum aluminum concentrations that are higher than children (aged and gender matched) that have never received parenteral nutrition. Read more about this study
- Who is it for?
- Ages 6 weeks to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Aluminum Contamination of Parenteral Nutrition
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Dec 2012
- 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 6 weeks to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients followed in the Home-TPN program at the Hospital for Sick Children
Who may be able to join
- For Cases on Long-term PN:
- On PN for ≥ 6 consecutive weeks
- Has had serum AL concentration drawn and recorded in the past
- For Control Subjects:
- Currently patients at the Hospital for Sick Children being followed on an inpatient ward or in an ambulatory clinic
- Are not on PN and have never received PN in the past
- Fed by mouth or enterally with feeding tube
Who cannot join
- For Cases on Long-term PN
- Patients who are on PN for shorter than 6 weeks
- Patients who never had serum AL concentration measured
- Patients who received albumin infusion before blood draw for Al concentration
- Patients on hemodialysis
- For Control Subjects
Show all 11Show fewer
- Patients who are not able to be matched to a case/subject on long-term PN for age and gender
- Patients who do not require blood work as a part of routine clinical monitoring
- Patients who are on PN
- Patients with known renal impairment
- Patients who received albumin infusion before blood draw for Al concentration -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Aluminum Concentration of Pediatric Patients Receiving Long-Term Parenteral Nutrition: Is There a Problem in Canada?
The purpose of this study is to determine whether children on long-term parenteral nutrition (>6 weeks) have serum aluminum concentrations that are higher than children (aged and gender matched) that have never received parenteral nutrition.
Read the detailed description
Aluminum contamination of parenteral nutrition (PN) solutions has been a concern for decades because of its link to metabolic bone disease (MBD) due to it's high aluminum content. Currently in the United States, FDA regulations are in place to protect American patients on PN from the effects of aluminum (AL) toxicity. Despite these regulations, pediatric patients on PN are still receiving higher than recommended AL intakes from PN.
Unlike the United States, there are no regulations governing AL content of or intakes from PN solutions in Canada. Consequently, the investigators are unaware of the AL content of the various PN solutions given to our patients. The investigators (the authors) have observed that a significant number of our patients on long-term PN (Home PN), have MBD. Some of our patients have also had bone fractures. The investigators have also observed alteration in calcium and phosphate concentrations as well as suppressed PTH. In an effort to understand the etiology of the MBD the investigators have measured serum AL concentrations in our patients and have found them to be high; between 900 - 2000 nmol/L compared to 0 to 220 nmol/L reported in healthy adults. This has led us to believe that there is a significant problem of AL contamination in PN solutions in Canada. Because the investigators are unable to obtain information on the AL content of the various PN solutions from the PN suppliers, the investigators have decided to report on the serum AL concentrations of our patients as well as the AL concentration of a random sample of PN solutions provided to patients. Plasma aluminum concentrations have already been analyzed in each of the cases. Blood was drawn for routine clinical monitoring on each subject after they had been on PN for six weeks or more.
This is the first step towards raising awareness of the potential problem. It is our hope that this will provide initial evidence to help guide Health Canada's decision regarding regulations on AL content in PN solutions in Canada.
- Keywords
- serum aluminum, parenteral nutrition, children
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| On long-term PN | Not described | |
| Never been on TPN | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum aluminum concentration
A 4 ml blood sample will be obtained from each control subject when they are giving blood for routine clinbical purposes. These subjects will be recruited from in-patient wards or ambulatory clinics. The aluminum content of samples (plasma aluminum concentration) will be determined by high resolution sector field inductively coupled mass spectrometry (HR-SF-ICP-MS). The accuracy and precision of the instrument used to determine aluminum concentration is measured using external and internal standards. Accuracy and precision was last measured at ± 0.5 to 2.5% and 5 to 10% respectively
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aluminum Contamination of Parenteral NutritionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glenda Courtney-Martin, The Hospital for Sick Children
- Investigators
- Glenda Courtney-Martin, MSc, PhD, RD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371123
- Sponsor's protocol ID
- 1000025865
- Status last verified
- Jul 2013
- First submitted
- 8 Jun 2011
- Last updated
- 29 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Courtney-Martin G, Kosar C, Campbell A, Avitzur Y, Wales PW, Steinberg K, Harrison D, Chambers K. Plasma Aluminum Concentrations in Pediatric Patients Receiving Long-Term Parenteral Nutrition. JPEN J Parenter Enteral Nutr. 2015 Jul;39(5):578-85. doi: 10.1177/0148607114531046. Epub 2014 Apr 17.
PubMed 24743391
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Aluminum Concentration of Pediatric Patients Receiving Long-Term Parenteral Nutrition: Is There a Problem in Canada?
- ClinicalTrials.gov ID
- NCT01371123
- Acronym / sponsor ID
- 1000025865
- Keywords
- serum aluminum, parenteral nutrition, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 Jun 2011 (estimated)
- 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.
The purpose of this study is to determine whether children on long-term parenteral nutrition (>6 weeks) have serum aluminum concentrations that are higher than children (aged and gender matched) that have never received parenteral nutrition.
Detailed description
Aluminum contamination of parenteral nutrition (PN) solutions has been a concern for decades because of its link to metabolic bone disease (MBD) due to it's high aluminum content. Currently in the United States, FDA regulations are in place to protect American patients on PN from the effects of aluminum (AL) toxicity. Despite these regulations, pediatric patients on PN are still receiving higher than recommended AL intakes from PN.
Unlike the United States, there are no regulations governing AL content of or intakes from PN solutions in Canada. Consequently, the investigators are unaware of the AL content of the various PN solutions given to our patients. The investigators (the authors) have observed that a significant number of our patients on long-term PN (Home PN), have MBD. Some of our patients have also had bone fractures. The investigators have also observed alteration in calcium and phosphate concentrations as well as suppressed PTH. In an effort to understand the etiology of the MBD the investigators have measured serum AL concentrations in our patients and have found them to be high; between 900 - 2000 nmol/L compared to 0 to 220 nmol/L reported in healthy adults. This has led us to believe that there is a significant problem of AL contamination in PN solutions in Canada. Because the investigators are unable to obtain information on the AL content of the various PN solutions from the PN suppliers, the investigators have decided to report on the serum AL concentrations of our patients as well as the AL concentration of a random sample of PN solutions provided to patients. Plasma aluminum concentrations have already been analyzed in each of the cases. Blood was drawn for routine clinical monitoring on each subject after they had been on PN for six weeks or more.
This is the first step towards raising awareness of the potential problem. It is our hope that this will provide initial evidence to help guide Health Canada's decision regarding regulations on AL content in PN solutions in Canada.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On long-term PN | – | – |
| Never been on TPN | – | – |
Who may qualify
- Ages
- 6 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients followed in the Home-TPN program at the Hospital for Sick Children
Key inclusion criteria (7 listed)
- On PN for ≥ 6 consecutive weeks
- Has had serum AL concentration drawn and recorded in the past
- Currently patients at the Hospital for Sick Children being followed on an inpatient ward or in an ambulatory clinic
- Are not on PN and have never received PN in the past
- Fed by mouth or enterally with feeding tube
Key exclusion criteria (11 listed)
- For Cases on Long-term PN
- Patients who are on PN for shorter than 6 weeks
- Patients who never had serum AL concentration measured
- Patients who received albumin infusion before blood draw for Al concentration
- Patients on hemodialysis
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
serum aluminum concentration
Time frame: 5 months
A 4 ml blood sample will be obtained from each control subject when they are giving blood for routine clinbical purposes. These subjects will be recruited from in-patient wards or ambulatory clinics. The aluminum content of samples (plasma aluminum concentration) will be determined by high resolution sector field inductively coupled mass spectrometry (HR-SF-ICP-MS). The accuracy and precision of the instrument used to determine aluminum concentration is measured using external and internal standards. Accuracy and precision was last measured at ± 0.5 to 2.5% and 5 to 10% respectively
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 29 Jul 2013.
- Derived from this study: PubMed 24743391Courtney-Martin G, Kosar C, Campbell A, Avitzur Y, Wales PW, Steinberg K, Harrison D, Chambers K. Plasma Aluminum Concentrations in Pediatric Patients Receiving Long-Term Parenteral Nutrition. JPEN J Parenter Enteral Nutr. 2015 Jul;39(5):578-85. doi: 10.1177/0148607114531046. Epub 2014 Apr 17.
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, MSc, 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 Aluminum Contamination of Parenteral Nutrition, 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 7 inclusion and 11 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 29 Jul 2013. 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?
serum aluminum concentration (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01371123, which also lists 1 linked publication.
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 29 Jul 2013.