Calcium Balance Studies in Children With CKD and on Dialysis (Cal-Bal)

NHS Foundation Trust

Status: Unknown

Conditions: Chronic Kidney Disease Mineral and Bone Disorder

Treatments: Diagnostic Test: Collection of blood, urine and stool samples

Study type: Observational

Funder types: Other

Identifiers

NCT03285854

15HM36

Details and patient eligibility

About

This is a novel, non-invasive method of assessing Ca balance by natural Ca isotope fractionation.

Full description

Detailed description and study protocol will be available to individuals on request.

Enrollment: 120 patients

Sex: All

Ages: Under 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

120 participants in 2 patient groups

Children with CKD stage 3-5 and dialysis

Description:

Children of all ages with an eGFR \<60ml/min/1.73m2, including those on dialysis

Treatment:

Diagnostic Test: Collection of blood, urine and stool samples

Healthy age and gender matched children

Description:

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.

Treatment:

Diagnostic Test: Collection of blood, urine and stool samples