Calcium Balance Studies in Children With CKD and on Dialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-01

Study Completion Date

2022-12-30

Brief Summary

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

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Detailed Description

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

Conditions

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Chronic Kidney Disease Mineral and Bone Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Children with CKD stage 3-5 and dialysis

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

Collection of blood, urine and stool samples

Intervention Type DIAGNOSTIC_TEST

Collection of blood, urine and stool samples, diet diary and bone scans

Healthy age and gender matched children

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.

Collection of blood, urine and stool samples

Intervention Type DIAGNOSTIC_TEST

Collection of blood, urine and stool samples, diet diary and bone scans

Interventions

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Collection of blood, urine and stool samples

Collection of blood, urine and stool samples, diet diary and bone scans

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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DEXA - lumbar spine and hips tibial peripheral quantitative CT Dietary record

Eligibility Criteria

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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.

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

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

* As listed above for healthy children.

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes