Calcium Balance Studies in Children With CKD and on Dialysis

• Conditions: Chronic Kidney Disease Mineral and Bone Disorder
• Interventions: Diagnostic Test: Collection of blood, urine and stool samples

• Registration Number: NCT03285854
• Lead Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust

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.

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-09-12
• Study First Submitted QC: 2017-09-13
• Study First Posted: 2017-09-18
• Primary Completion: 2021-12-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-16
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with CKD stage 3-5 and dialysis	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	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Great Ormond Street Hospital for Children NHS Foundation Trust; 🇬🇧 London, United Kingdom