Status:
UNKNOWN
Calcium Balance Studies in Children With CKD and on Dialysis
Lead Sponsor:
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborating Sponsors:
University of Kiel
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
Conditions:
Chronic Kidney Disease Mineral and Bone Disorder
Eligibility:
All Genders
Up to 18 years
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.
Eligibility Criteria
Inclusion
- 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.
- Exclusion criteria
- As listed above for healthy children.
Exclusion
Key Trial Info
Start Date :
February 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03285854
Start Date
February 1 2017
End Date
December 30 2022
Last Update
March 16 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Great Ormond Street Hospital for Children NHS Foundation Trust
London, United Kingdom, WC1N 3JH