Assessing Calcium Balance in Children With Chronic Kidney Disease to Optimise Treatment Strategies
| Registry | NCT03285854, acronym Cal-Bal |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 120 (Actual) |
| Sponsor | Great Ormond Street Hospital for Children NHS Foundation Trust (Other); collaborators: University of Kiel, Athens General Children's Hospital "Pan. & Aglaia Kyriakou", Cukurova University |
| Conditions | Chronic Kidney Disease Mineral and Bone Disorder |
| Interventions | Collection of blood, urine and stool samples (Diagnostic test) |
| Dates | start 2017-02-01, primary completion 2021-12-30, completion 2022-12-30 (estimated), first posted 2017-09-18, last updated 2022-03-16 |
| Locations | 1 site in United Kingdom |
Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Kidney Disease Mineral and Bone Disorder All trials of Collection of blood, urine and stool samples
This is a novel, non-invasive method of assessing Ca balance by natural Ca isotope fractionation.
Detailed description and study protocol will be available to individuals on request.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Children with CKD stage 3-5 and dialysis | Diagnostic Test: Collection of blood, urine and stool samples | Children 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 samples | 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. |
Sex: All, ages: any to 18 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Great Ormond Street Hospital for Children NHS Foundation Trust | London | United Kingdom |