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Completed

NCT Number: NCT01603472

Markers of Bone Disease in Children on Parenteral Nutrition

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.

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Key information

Age range

6 week–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children

Toronto, Ontario, MG 1X8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

  1. serum osteocalcin

    Time frame: Over 8 months

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Rare Disease Foundation, Vancouver, Canada

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 22, 2012
Registry last updated
Jul 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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