Markers of Bone Disease in Children on Parenteral Nutrition

This study has been completed.
Sponsor:
Collaborator:
Rare Disease Foundation, Vancouver, Canada
Information provided by (Responsible Party):
Glenda Courtney-Martin, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01603472
First received: May 18, 2012
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

Parenteral nutrition (PN) is the provision of nutrients via the intravenous route. Parenteral nutrition associated metabolic bone disease (MBD) was first described in children in the 1980s. Since then, there has been little to no research into the underlying relationship and as a result, little evidence on which to base clinical care. In adults, MBD is associated with increased fractures. At the Hospital for Sick children in Toronto, an intestinal failure program has been set up since 2003. This is the only intestinal failure program in Canada and receives country wide referrals. Most of the patients have short bowel syndrome (SBS) and require PN for prolonged periods, or for life. About 90% of these patients have MBD, and some have had bone fractures. An understanding of the etiology of MBD would provide information to guide care, and prevent this condition. Funding for this area of research however is challenging because intestinal failure requiring long term PN is a rare condition, accounting for approximately 200 - 300 children in all of Canada. The goal of this study therefore is to gather pilot data on markers of MBD in children on long term PN, and to compare these markers to age and gender matched control patients who are fed by mouth or feeding tube. The information gathered from this study will help us begin to understand what is actually happening in the bones of children on long term PN and will form the basis for future studies and improved clinical care.


Condition
Metabolic Bone Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Markers of Parenteral Nutrition (PN) Associated Metabolic Bone Disease in Children on Long-Term PN for Intestinal Failure.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • serum osteocalcin [ Time Frame: Over 8 months ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: May 2012
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Subjects on Parenteral Nutrition
cases are those on Parenteral Nutrition >6 weeks for intestinal failure.
Subjects not on Parenteral Nutrion
Controls are those who have never been on PN but can be fed via a feeding tube

  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

Children on long term PN and childen not on PN.

Criteria

INCLUSION CRITERIA:

For Cases on Long-term PN:

  1. On PN for ≥ 6 consecutive weeks
  2. Willingness to participate in the study

For Control Subjects:

  1. Healthy as assessed by history and physical exam.
  2. Growing normally
  3. Are not on medications known to affect bone metabolism eg. Corticosteroids.
  4. Never received PN in the past

EXCLUSION CRITERIA:

For Cases on Long-term PN

  1. Patients who are on PN for shorter than 6 weeks
  2. Patients on hemodialysis

For Control Subjects

  1. Subjects who are not able to be matched to a case/subject on long-term PN for age and gender
  2. Positive history of fractures
  3. Subjects who are unable to participate because of fear of giving blood or unable to come to the hospital for sick children for blood draws.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01603472

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, MG 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Rare Disease Foundation, Vancouver, Canada
Investigators
Principal Investigator: Glenda Courtney-Martin The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Glenda Courtney-Martin, Academic &Clinical Specialist, Project Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01603472     History of Changes
Other Study ID Numbers: 1000028242
Study First Received: May 18, 2012
Last Updated: July 26, 2013
Health Authority: Canada: Research Ethics Board

Keywords provided by The Hospital for Sick Children:
pediatric
parenteral nutrition
bone disease
long-term PN

Additional relevant MeSH terms:
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 22, 2014