Intestinal FailureNCT05909228
Bone Markers in Pediatric IF
An observational study of Intestinal Failure and Osteoporosis, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 weeks to 18 years
- Conditions the study is for
- Intestinal Failure, Osteoporosis, Metabolic Bone Disease
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 31 Mar 2023to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks to 18 years
- All sexes
- Child, Adult
Study population: Children with intestinal failure on parenteral nutrition and healthy controls without parenteral nutrition.
Who may be able to join
- In order to be eligible to participate in this study, a patient must meet all of the following criteria at time of inclusion:
- 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).
- For healthy controls the inclusion criteria are as follows:
Show all 18Show fewer
- 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.
- For healthy controls, the exclusion criteria are as follows:
- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bone Turnover Markers in Children With Intestinal Failure After Optimization of Parenteral Nutrition
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.
Read the detailed description
It is currently unknown if optimization of PN mixtures leads to a measurable change in bone turnover markers. Our hypothesis is that bone turnover markers of children with IF whose PN has been optimized will not differ from those of healthy control subjects, with a positive effect on bone mineral density.
Our aims are:
- To measure bone turnover markers in children with IF on long-term PN and compare them with age- and sex-matched healthy children who never received PN
- To evaluate if changes in bone turnover markers are related to changes in bone mineral density measured by Dual energy X-ray absorptiometry (DXA)
- To identify IF- and PN-related factors associated with bone health
To be able to answer these aims, bone markers in children with IF will be compared to bone markers in healthy controls, age- and sex-matched.
- Conditions
- Intestinal Failure, Osteoporosis, Metabolic Bone Disease
- Medical subject headings
- Intestinal Failure, Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with intestinal failure | Children with intestinal failure on parenteral nutrition | |
| Healthy controls | Healthy controls without parenteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (3)
Bone health
Association of serum osteocalcin, C-telopeptide and bone-specific alkaline phosphatase with bone mineral density Z-scores for lumber spine and total body less head obtained from DXA scans performed as standard clinical care.
Measured: 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
Association of intestinal failure and parenteral nutrition related factors such as duration of parenteral nutrition (y) with serum osteocalcin, C-telopeptide and bone-specific alkaline phosphatase levels.
Measured: Baseline
Intestinal failure and parenteral nutrition related factors
Association of intestinal failure and parenteral nutrition related factors such as parenteral nutrition dependency index (%) with serum osteocalcin, C-telopeptide and bone-specific alkaline phosphatase levels.
Measured: Intestinal failure and parenteral nutrition related factors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start31 Mar 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glenda Courtney-Martin, The Hospital for Sick Children
- Investigators
- Glenda Courtney-Martin, PhD, RD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909228
- Sponsor's protocol ID
- 1000080417
- Status last verified
- Jan 2024
- First submitted
- 31 May 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Turnover Markers in Children With Intestinal Failure After Optimization of Parenteral Nutrition
- ClinicalTrials.gov ID
- NCT05909228
- Acronym / sponsor ID
- 1000080417
- Conditions
- Intestinal Failure, Osteoporosis, Metabolic Bone Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It is currently unknown if optimization of PN mixtures leads to a measurable change in bone turnover markers. Our hypothesis is that bone turnover markers of children with IF whose PN has been optimized will not differ from those of healthy control subjects, with a positive effect on bone mineral density.
Our aims are:
- To measure bone turnover markers in children with IF on long-term PN and compare them with age- and sex-matched healthy children who never received PN
- To evaluate if changes in bone turnover markers are related to changes in bone mineral density measured by Dual energy X-ray absorptiometry (DXA)
- To identify IF- and PN-related factors associated with bone health
To be able to answer these aims, bone markers in children with IF will be compared to bone markers in healthy controls, age- and sex-matched.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with intestinal failure | – | –Children with intestinal failure on parenteral nutrition |
| Healthy controls | – | –Healthy controls without parenteral nutrition |
Who may qualify
- Ages
- 6 weeks to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children with intestinal failure on parenteral nutrition and healthy controls without parenteral nutrition.
Key inclusion criteria (18 listed)
- In order to be eligible to participate in this study, a patient must meet all of the following criteria at time of inclusion:
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone turnover markers - Osteocalcin
Time frame: Baseline
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.
Bone turnover markers - C-telopeptide
Time frame: Baseline
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.
Bone turnover markers - Bone-specific alkaline phosphatase
Time frame: Baseline
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.
3 secondary outcomes
Bone health
Time frame: 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
Time frame: Baseline
Intestinal failure and parenteral nutrition related factors
Time frame: Intestinal failure and parenteral nutrition related factors
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenda Courtney-Martin, PhD, RD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Failure and Osteoporosis, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone turnover markers - Osteocalcin (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.