Calcium Balance Studies in Children With CKD and on Dialysis

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Kidney Disease Mineral and Bone Disorder

Intervention / Treatment
-----------------
* Diagnostic Test: Collection of blood, urine and stool samples


Participation Criteria
=================
Eligibility 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. Exclusion criteria As listed above for healthy children.

Ages Eligible for Study
-----------------
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with CKD stage 3-5 and dialysis<br>Children of all ages with an eGFR <60ml/min/1.73m2, including those on dialysis | Diagnostic Test: Collection of blood, urine and stool samples<br>* Collection of blood, urine and stool samples, diet diary and bone scans<br>* Other names: Dietary record;|
| Healthy age and gender matched children<br>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. | Diagnostic Test: Collection of blood, urine and stool samples<br>* Collection of blood, urine and stool samples, diet diary and bone scans<br>* Other names: Dietary record;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcium isotope fractionation in blood, urine and stool in healthy children and those with CKD | available on request | 24 months | 
| number of children with fractures, and clinical and biochemical correlates of fractures | available on request | 12 months | 
| Bone scans - whole body & lumbar spine DEXA, bone mineral density on tibial peripheral quantitative CT scan | available on request | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DXA, Dialysis, calcium, mineral and bone disorder (MBD), calcification, peripheral quantitative CT scan (pqCT), CKD