Markers of Bone Disease in Children on Parenteral Nutrition

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01603472

Enrollment

Registered

2012-05-22

Start date

2012-05-31

Completion date

2012-10-31

Last updated

2013-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Bone Disease

Keywords

pediatric, parenteral nutrition, bone disease, long-term 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

6 Weeks to 18 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
serum osteocalcin	Over 8 months

Countries

Canada

Outcome results