Skip to content

Calcium Balance Studies in Children With CKD and on Dialysis

Assessing Calcium Balance in Children With Chronic Kidney Disease to Optimise Treatment Strategies

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03285854
Acronym
Cal-Bal
Enrollment
120
Registered
2017-09-18
Start date
2017-02-01
Completion date
2022-12-30
Last updated
2022-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease Mineral and Bone Disorder

Keywords

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

Brief summary

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.

Interventions

DIAGNOSTIC_TESTCollection of blood, urine and stool samples

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

Sponsors

University of Kiel
CollaboratorOTHER
Athens General Children's Hospital Pan. & Aglaia Kyriakou
CollaboratorOTHER
Cukurova University
CollaboratorOTHER
Great Ormond Street Hospital for Children NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes

Inclusion criteria

I - For healthy children Inclusion criteria * 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Calcium isotope fractionation in blood, urine and stool in healthy children and those with CKD24 monthsavailable on request
number of children with fractures, and clinical and biochemical correlates of fractures12 monthsavailable on request
Bone scans - whole body & lumbar spine DEXA, bone mineral density on tibial peripheral quantitative CT scan24 monthsavailable on request

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026