NCT05909228

Brief Summary

Poor bone health is a well-recognized but poorly understood complication in children with intestinal failure (IF) who are dependent on parenteral nutrition (PN). Previously, we showed that children with IF have decreased bone turnover markers. It is currently unknown if optimization of parenteral nutrition is related to improved bone turnover markers. Serum concentrations of bone markers (osteocalcin, bone-specific alkaline phosphatase and c-telopeptide) will be measured in 30 IF patients treated at a multidisciplinary intestinal rehabilitation and home PN program at the Hospital for Sick Children and compared to bone markers in 30 age- and sex-matched healthy controls.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

May 31, 2023

Last Update Submit

January 12, 2024

Conditions

Intestinal FailureOsteoporosisMetabolic Bone Disease

Outcome Measures

Primary Outcomes (3)

  • Bone turnover markers - Osteocalcin

    To measure serum osteocalcin levels in children with intestinal failure on long-term parenteral nutrition and compare them with age- and sex-matched healthy children who never received parenteral nutrition.

    Baseline

  • Bone turnover markers - C-telopeptide

    To measure serum C-telopeptide levels in children with intestinal failure on long-term parenteral nutrition and compare them with age- and sex-matched healthy children who never received parenteral nutrition.

    Baseline

  • Bone turnover markers - Bone-specific alkaline phosphatase

    To measure serum bone-specific alkaline phosphatase levels in children with intestinal failure on long-term parenteral nutrition and compare them with age- and sex-matched healthy children who never received parenteral nutrition.

    Baseline

Secondary Outcomes (3)

  • Bone health

    DXA scan results will be collected when performed within 6 months of the blood draw for the bone markers.

  • Intestinal failure and parenteral nutrition related factors

    Baseline

  • Intestinal failure and parenteral nutrition related factors

    Intestinal failure and parenteral nutrition related factors

Study Arms (2)

Children with intestinal failure

Children with intestinal failure on parenteral nutrition

Healthy controls

Healthy controls without parenteral nutrition

Eligibility Criteria

Age6 Weeks - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children with intestinal failure on parenteral nutrition and healthy controls without parenteral nutrition.

You may qualify if:

  • Consent provided
  • Age \< 18 years
  • Suffering from IF needing PN providing at least 25% of calories for ≥6 weeks
  • Medically stable with no acute changes in condition requiring hospitalization, or other intervention at home (for at least 3 months).
  • Consent provided
  • Age \< 18 years.
  • A patient who meets any of the following criteria will be excluded from participation in this study:
  • On PN for \< 6 weeks
  • Suffering from an acute clinical event, for example gastroenteritis, colds and flu
  • Suffering from sepsis on antibiotics
  • On medication known to affect bone metabolism, for example steroids
  • Having a history of fracture within the last 12 months.

You may not qualify if:

  • Any condition known to affect bone health (chronic disease, bone disease, history of malignancy, radiotherapy, steroid use, mental or physical disability)
  • A positive history of fractures within the past 2 years
  • Poor growth (weight- and height-for-age below - 2 or above + 2 standard deviation score using the WHO growth charts).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bone markers: osteocalcin, bone-specific alkaline phosphatase and c-telopeptide

MeSH Terms

Conditions

Intestinal FailureOsteoporosisBone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Glenda Courtney-Martin, PhD, RD

    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
Principal Investigator

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 18, 2023

Study Start

March 31, 2023

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

January 16, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)