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Serum Aluminum Concentration of Pediatric Patients Receiving Long-Term Parenteral Nutrition

This study is currently recruiting participants.
Verified June 2011 by The Hospital for Sick Children
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01371123
First received: June 8, 2011
Last updated: June 9, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition
Aluminum Contamination of Parenteral Nutrition

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Serum Aluminum Concentration of Pediatric Patients Receiving Long-Term Parenteral Nutrition: Is There a Problem in Canada?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • serum aluminum concentration [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   None Retained

serum


Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
On long-term PN
Never been on TPN

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.

  Eligibility

Ages Eligible for Study:   6 Weeks to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients followed in the Home-TPN program at the Hospital for Sick Children

Criteria

Inclusion Criteria:

For Cases on Long-term PN:

  1. On PN for ≥ 6 consecutive weeks
  2. Has had serum AL concentration drawn and recorded in the past

For Control Subjects:

  1. Currently patients at the Hospital for Sick Children being followed on an inpatient ward or in an ambulatory clinic
  2. Are not on PN and have never received PN in the past
  3. Fed by mouth or enterally with feeding tube

Exclusion Criteria:

For Cases on Long-term PN

  1. Patients who are on PN for shorter than 6 weeks
  2. Patients who never had serum AL concentration measured
  3. Patients who received albumin infusion before blood draw for Al concentration
  4. Patients on hemodialysis

For Control Subjects

  1. Patients who are not able to be matched to a case/subject on long-term PN for age and gender
  2. Patients who do not require blood work as a part of routine clinical monitoring
  3. Patients who are on PN
  4. Patients with known renal impairment
  5. Patients who received albumin infusion before blood draw for Al concentration -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371123

Contacts
Contact: Glenda Courtney-Martin, MSc, RD, PhD 416-813-5744 glenda.courtney-martin@sickkids.ca
Contact: Alison Campbell, BSc. 416-813-7654 ext 8852 alison.campbell@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Glenda Courtney-Martin, MSc, PhD     416-813-5744     glenda.courtney-martin@sickkids.ca    
Contact: Alison Campbell, BSc.     416-813-7654 ext 8852     alison.campbell@sickkids.ca    
Principal Investigator: Glenda Courtney-Martin, MSc., PhD            
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Glenda Courtney-Martin, MSc, PhD, RD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Glenda Courtney-Martin. MSc, RD, PhD/ Principal Investigator, The Hospital for Sick Children, Toronto, ON. M5G 1X8
ClinicalTrials.gov Identifier: NCT01371123     History of Changes
Other Study ID Numbers: 1000025865
Study First Received: June 8, 2011
Last Updated: June 9, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
serum aluminum
parenteral nutrition
children

ClinicalTrials.gov processed this record on May 21, 2013