Markers of Bone Disease in Children on Parenteral Nutrition

NCT ID: NCT01603472

Last Updated: 2013-07-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-10-31

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.

Conditions

Metabolic Bone Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Subjects on Parenteral Nutrition

cases are those on Parenteral Nutrition \>6 weeks for intestinal failure.

No interventions assigned to this group

Subjects not on Parenteral Nutrion

Controls are those who have never been on PN but can be fed via a feeding tube

No interventions assigned to this group

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.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rare Disease Foundation, Vancouver, Canada

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Glenda Courtney-Martin

Academic &Clinical Specialist, Project Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Glenda Courtney-Martin

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000028242

Identifier Type: -

Identifier Source: org_study_id