Chronic Kidney Disease Mineral and Bone DisorderCal-BalNCT03285854
Calcium Balance Studies in Children With CKD and on Dialysis
An observational study of Chronic Kidney Disease Mineral and Bone Disorder, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a novel, non-invasive method of assessing Ca balance by natural Ca isotope fractionation. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease Mineral and Bone Disorder
- What is being tested?
- Collection of blood, urine and stool samples
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2017to 30 Dec 2022
- 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All children with chronic kidney disease stage 3-5 and on dialysis and age matched controls
Who may be able to join
- All children <18 years
- Normal renal function (eGFR 90-120ml/min/1.73m2 [calculated by Schwartz formula] in children >1 year and serum creatinine <35μMol/L in children <1 year)
- Weight, height and BMI within 2 SD of normal using WHO growth charts In order to make this study as 'real-life' as possible, free-living UK children on their usual diet and dietary supplementation (including Ca and Vit D), if any, will be included, but analysis will account for medication doses and blood levels.
- Children of all ages with an eGFR <60ml/min/1.73m2, including those on dialysis.
Who cannot join
- Pre-existing bone disease - inherited or acquired
- Fractures in the preceding 6 months
- Glucocorticoid therapy in the preceding year, or a lifetime cumulative steroid exposure ≥6 months
- Bisphosphonate therapy at any time in the past
- Any acute illness in the preceding 2 weeks (when the child is unable to maintain their usual diet or has bed rest)
- II - For CKD and dialysis children
- As listed above for healthy children.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Great Ormond Street Hospital for Children NHS Foundation Trust
London, WC1N 3JH
About this study
Official title: Assessing Calcium Balance in Children With Chronic Kidney Disease to Optimise Treatment Strategies
This is a novel, non-invasive method of assessing Ca balance by natural Ca isotope fractionation.
Read the detailed description
Detailed description and study protocol will be available to individuals on request.
- Being tested
- Collection of blood, urine and stool samples
- Keywords
- CKD, Dialysis, calcium, mineral and bone disorder (MBD), calcification, DXA, peripheral quantitative CT scan (pqCT)
- Medical subject headings
- Chronic Kidney Disease-Mineral and Bone Disorder, Calcinosis, Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of blood, urine and stool samplesDiagnostic test
Also called DEXA - lumbar spine and hips, tibial peripheral quantitative CT, Dietary record
Collection of blood, urine and stool samples, diet diary and bone scans
| Study group | Role | What they receive |
|---|---|---|
| Children with CKD stage 3-5 and dialysis | Children of all ages with an eGFR <60ml/min/1.73m2, including those on dialysis Receives: Diagnostic Test: Collection of blood, urine and stool samples | |
| Healthy age and gender matched children | 1. All children <18 years
2. Normal renal function (eGFR 90-120ml/min/1.73m2 [calculated by Schwartz formula] in children >1 year and serum creatinine <35μMol/L in children <1 year)
3. Weight, height and BMI within 2 SD of normal using WHO growth charts In order to make this study as 'real-life' as possible, free-living UK children on their usual diet and dietary supplementation (including Ca and Vit D), if any, will be included, but analysis will account for medication doses and blood levels. Receives: Diagnostic Test: Collection of blood, urine and stool samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium isotope fractionation in blood, urine and stool in healthy children and those with CKD
available on request
Measured: 24 months
number of children with fractures, and clinical and biochemical correlates of fractures
available on request
Measured: 12 months
Bone scans - whole body & lumbar spine DEXA, bone mineral density on tibial peripheral quantitative CT scan
available on request
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start1 Feb 2017
- Primary completion30 Dec 2021
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Mineral and Bone DisorderStudies 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
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kiel, Athens General Children's Hospital "Pan. & Aglaia Kyriakou", Cukurova University
- Responsible party
- Sponsor
- Investigators
- Rukshana C Shroff, MD PhD, Principal investigator, Great Ormond Street Hospital for Children NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285854
- Sponsor's protocol ID
- 15HM36
- Acronym
- Cal-Bal
- Status last verified
- Mar 2022
- First submitted
- 12 Sep 2017
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing will be considered at the end of the study.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Calcium Balance in Children With Chronic Kidney Disease to Optimise Treatment Strategies
- ClinicalTrials.gov ID
- NCT03285854
- Acronym / sponsor ID
- Cal-Bal / 15HM36
- Keywords
- CKD, Dialysis, calcium, mineral and bone disorder (MBD), calcification, DXA, peripheral quantitative CT scan (pqCT)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Kiel, Athens General Children's Hospital "Pan. & Aglaia Kyriakou", Cukurova University
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 18 Sep 2017 (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.
This is a novel, non-invasive method of assessing Ca balance by natural Ca isotope fractionation.
Detailed description
Detailed description and study protocol will be available to individuals on request.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with CKD stage 3-5 and dialysis | – | Diagnostic Test: Collection of blood, urine and stool samplesChildren of all ages with an eGFR <60ml/min/1.73m2, including those on dialysis |
| Healthy age and gender matched children | – | Diagnostic Test: Collection of blood, urine and stool samples1. All children <18 years 2. Normal renal function (eGFR 90-120ml/min/1.73m2 [calculated by Schwartz formula] in children >1 year and serum creatinine <35μMol/L in children <1 year) 3. Weight, height and BMI within 2 SD of normal using WHO growth charts In order to make this study as 'real-life' as possible, free-living UK children on their usual diet and dietary supplementation (including Ca and Vit D), if any, will be included, but analysis will account for medication doses and blood levels. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All children with chronic kidney disease stage 3-5 and on dialysis and age matched controls
Key inclusion criteria (4 listed)
- All children <18 years
- Normal renal function (eGFR 90-120ml/min/1.73m2 [calculated by Schwartz formula] in children >1 year and serum creatinine <35μMol/L in children <1 year)
- Weight, height and BMI within 2 SD of normal using WHO growth charts In order to make this study as 'real-life' as possible, free-living UK children on their usual diet and dietary supplementation (including Ca and Vit D), if any, will be included, but analysis will account for medication doses and blood levels.
- Children of all ages with an eGFR <60ml/min/1.73m2, including those on dialysis.
Key exclusion criteria (7 listed)
- Pre-existing bone disease - inherited or acquired
- Fractures in the preceding 6 months
- Glucocorticoid therapy in the preceding year, or a lifetime cumulative steroid exposure ≥6 months
- Bisphosphonate therapy at any time in the past
- Any acute illness in the preceding 2 weeks (when the child is unable to maintain their usual diet or has bed rest)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of blood, urine and stool samplesAlso: DEXA - lumbar spine and hips, tibial peripheral quantitative CT, Dietary recordCollection of blood, urine and stool samples, diet diary and bone scans | Diagnostic test | Children with CKD stage 3-5 and dialysis, Healthy age and gender matched children |
Primary outcome
Calcium isotope fractionation in blood, urine and stool in healthy children and those with CKD
Time frame: 24 months
available on request
number of children with fractures, and clinical and biochemical correlates of fractures
Time frame: 12 months
available on request
Bone scans - whole body & lumbar spine DEXA, bone mineral density on tibial peripheral quantitative CT scan
Time frame: 24 months
available on request
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: Undecided. IPD sharing will be considered at the end of the study.
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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.
Rukshana C Shroff, MD PhD principal investigator
Great Ormond Street Hospital for Children NHS Foundation Trust
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 Chronic Kidney Disease Mineral and Bone Disorder, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 16 Mar 2022. 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 United Kingdom. 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?
Results are not available in the source record.
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?
Calcium isotope fractionation in blood, urine and stool in healthy children and those with CKD (time frame: 24 months). 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 Mar 2022.