ClinicalTrials.gg
Status unknownNCT03285854Cal-BalUpdated Mar 16, 2022

Calcium Balance Studies in Children With CKD and on Dialysis

An observational study in Chronic Kidney Disease Mineral and Bone Disorder, sponsored by Great Ormond Street Hospital for Children NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged Up to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-16.

Sponsored by Great Ormond Street Hospital for Children NHS Foundation Trust · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
120
Ages
Up to 18 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Kidney Disease Mineral and Bone Disorder

Keywords

  • CKD
  • Dialysis
  • calcium
  • mineral and bone disorder (MBD)
  • calcification
  • DXA
  • peripheral quantitative CT scan (pqCT)
03

In context

Chronic Kidney Disease-Mineral and Bone Disorder

73 studies on the registry are indexed under Chronic Kidney Disease-Mineral and Bone Disorder; 20 are open to participants now.

This study's enrollment of 120 is below the median of 164 across 36 observational studies indexed under Chronic Kidney Disease-Mineral and Bone Disorder.

Browse Chronic Kidney Disease-Mineral and Bone Disorder studies →

Lead sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust is the lead sponsor of 82 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

All children with chronic kidney disease stage 3-5 and on dialysis and age matched controls

Eligibility criteria

I - For healthy children

Inclusion criteria

  • All children \<18 years
  • Normal renal function ( 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 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.

Exclusion criteria

  • Pre-existing bone disease - inherited or acquired
  • Fractures in the preceding 6 months
  • 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

Inclusion criteria

  • Children of all ages with an eGFR \<60ml/min/1.73m2, including those on dialysis.

Exclusion criteria

  • As listed above for healthy children.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Children with CKD stage 3-5 and dialysis

    Children of all ages with an eGFR \<60ml/min/1.73m2, including those on dialysis

    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.

    Diagnostic Test: Collection of blood, urine and stool samples

Interventions

  • Diagnostic testCollection of blood, urine and stool samples

    Collection of blood, urine and stool samples, diet diary and bone scans

    Also known as: DEXA - lumbar spine and hips, tibial peripheral quantitative CT, Dietary record

06

What researchers measure

Primary outcomes

  1. Calcium isotope fractionation in blood, urine and stool in healthy children and those with CKD

    available on request

    Time frame: 24 months

  2. number of children with fractures, and clinical and biochemical correlates of fractures

    available on request

    Time frame: 12 months

  3. Bone scans - whole body & lumbar spine DEXA, bone mineral density on tibial peripheral quantitative CT scan

    available on request

    Time frame: 24 months

07

Study locations

1 site
  • Great Ormond Street Hospital for Children NHS Foundation Trust
    London, WC1N 3JH, United Kingdom
08

References and documents

Individual participant data

Plan to share: Undecided — IPD sharing will be considered at the end of the study.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03285854
Lead sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborators
University of Kiel, Athens General Children's Hospital "Pan. & Aglaia Kyriakou", Cukurova University
Responsible party
Sponsor
First posted
Sep 18, 2017
Start date
Feb 1, 2017
Primary completion
Dec 30, 2021
Completion
Dec 30, 2022 (estimated)
Last update
Mar 16, 2022

Study contacts

Rukshana C Shroff, MD PhD
principal investigator · Great Ormond Street Hospital for Children NHS Foundation Trust

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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