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

March 15, 2022 updated by: Great Ormond Street Hospital for Children NHS Foundation Trust

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1N 3JH
        • Great Ormond Street Hospital for Children NHS foundation trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All children with chronic kidney disease stage 3-5 and on dialysis and age matched controls

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children with CKD stage 3-5 and dialysis
Children of all ages with an eGFR <60ml/min/1.73m2, including those on dialysis
Diagnostic test: Collection of blood, urine and stool samples
Collection of blood, urine and stool samples, diet diary and bone scans
Other Names:
  • DEXA - lumbar spine and hips
  • tibial peripheral quantitative CT
  • Dietary record
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.
Diagnostic test: Collection of blood, urine and stool samples
Collection of blood, urine and stool samples, diet diary and bone scans
Other Names:
  • DEXA - lumbar spine and hips
  • tibial peripheral quantitative CT
  • Dietary record

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Collaborators

Cukurova University
University of Kiel
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"

Investigators

  • Principal Investigator: Rukshana C Shroff, MD PhD, Great Ormond Street Hospital for Children NHS foundation trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

December 30, 2021

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

September 12, 2017

First Submitted That Met QC Criteria

September 13, 2017

First Posted (Actual)

September 18, 2017

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15HM36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

IPD sharing will be considered at the end of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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