Markers of Bone Disease in Children on Parenteral Nutrition

Metabolic Bone Disease Clinical Trial

Official title:

Markers of Parenteral Nutrition (PN) Associated Metabolic Bone Disease in Children on Long-Term PN for Intestinal Failure.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603472
• Other study ID #: 1000028242
• Status: Completed
• Phase: N/A
• First received: May 18, 2012
• Last updated: July 26, 2013
• Start date: May 2012
• Est. completion date: October 2012

Study information

• Verified date: July 2013
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Research Ethics Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 18 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Metabolic
• Metabolic Bone Disease

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Rare Disease Foundation, Vancouver, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum osteocalcin		Over 8 months	No