Markers of Bone Disease in Children on Parenteral Nutrition

NCT01603472 | Completed

• 1 other identifier: 1000028242
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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

Keywords

pediatric; parenteral nutrition; bone disease; long-term PN

Outcome Measures

Primary Outcomes (1)

• serum osteocalcin

  Over 8 months

Study Arms (2)

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 Criteria

• Age: 6 Weeks - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children on long term PN and childen not on PN.

You may qualify if:

• For Cases on Long-term PN:
• On PN for ≥ 6 consecutive weeks
• Willingness to participate in the study
• For Control Subjects:
• Healthy as assessed by history and physical exam.
• Growing normally
• Are not on medications known to affect bone metabolism eg. Corticosteroids.
• Never received PN in the past

You may not qualify if:

• For Cases on Long-term PN
• Patients who are on PN for shorter than 6 weeks
• Patients on hemodialysis
• For Control Subjects
• Subjects who are not able to be matched to a case/subject on long-term PN for age and gender
• Positive history of fractures
• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Rare Disease Foundation, Vancouver, Canada: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, MG 1X8, Canada

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Hyperphagia; Bone Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Glenda Courtney-Martin

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic &Clinical Specialist, Project Investigator

Study Record Dates

• First Submitted: May 18, 2012
• First Posted: May 22, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: July 29, 2013

Record last verified: 2013-07

Locations

CA (1)