Clinical trial NCT01603472: Markers of Bone Disease in Children on Parenteral Nutrition
Official title: Markers of Parenteral Nutrition (PN) Associated Metabolic Bone Disease in Children on Long-Term PN for Intestinal Failure.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Bone Disease
Keywords: pediatric
parenteral nutrition
bone disease
long-term PN
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Rare Disease Foundation, Vancouver, Canada
First posted: 2012-05-22
Enrollment: 38
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children on long term PN and childen not on PN.

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: serum osteocalcin
timeFrame: Over 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Glenda Courtney-Martin
role: PRINCIPAL_INVESTIGATOR
References: