Chronic Kidney Disease Mineral and Bone Disorder Clinical Trial
— Cal-BalOfficial title:
Assessing Calcium Balance in Children With Chronic Kidney Disease to Optimise Treatment Strategies
Verified date | March 2022 |
Source | Great Ormond Street Hospital for Children NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a novel, non-invasive method of assessing Ca balance by natural Ca isotope fractionation.
Status | Active, not recruiting |
Enrollment | 120 |
Est. completion date | December 30, 2022 |
Est. primary completion date | December 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Great Ormond Street Hospital for Children NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
Great Ormond Street Hospital for Children NHS Foundation Trust | Athens General Children's Hospital "Pan. & Aglaia Kyriakou", Cukurova University, University of Kiel |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Calcium isotope fractionation in blood, urine and stool in healthy children and those with CKD | available on request | 24 months | |
Primary | number of children with fractures, and clinical and biochemical correlates of fractures | available on request | 12 months | |
Primary | Bone scans - whole body & lumbar spine DEXA, bone mineral density on tibial peripheral quantitative CT scan | available on request | 24 months |
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