Calcium Balance Studies in Children With CKD and on Dialysis

Chronic Kidney Disease Mineral and Bone Disorder Clinical Trial

— Cal-Bal  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03285854
• Other study ID #: 15HM36
• Status: Active, not recruiting
• Start date: February 1, 2017
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2022
• Source: Great Ormond Street Hospital for Children NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Bone Diseases
• Chronic Kidney Disease Mineral and Bone Disorder
• Chronic Kidney Disease-Mineral and Bone Disorder
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Diagnostic Test:
• Collection of blood, urine and stool samples
Collection of blood, urine and stool samples, diet diary and bone scans

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital for Children NHS Foundation Trust	London

Sponsors (4)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

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