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

Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03285854
Collaborator
University of Kiel (Other), Athens General Children's Hospital "Pan. & Aglaia Kyriakou" (Other), Cukurova University (Other)
120
Enrollment
1
Location
70.9
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Collection of blood, urine and stool samples

Detailed Description

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

Study Design

Study Type:
Observational
Actual Enrollment :
120 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Assessing Calcium Balance in Children With Chronic Kidney Disease to Optimise Treatment Strategies
Actual Study Start Date :
Feb 1, 2017
Actual Primary Completion Date :
Dec 30, 2021
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm 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

    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.

    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Calcium isotope fractionation in blood, urine and stool in healthy children and those with CKD [24 months]

      available on request

    2. number of children with fractures, and clinical and biochemical correlates of fractures [12 months]

      available on request

    3. Bone scans - whole body & lumbar spine DEXA, bone mineral density on tibial peripheral quantitative CT scan [24 months]

      available on request

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Great Ormond Street Hospital for Children NHS Foundation Trust London United Kingdom WC1N 3JH

    Sponsors and Collaborators

    • Great Ormond Street Hospital for Children NHS Foundation Trust
    • University of Kiel
    • Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
    • Cukurova University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Great Ormond Street Hospital for Children NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT03285854
    Other Study ID Numbers:
    • 15HM36
    First Posted:
    Sep 18, 2017
    Last Update Posted:
    Mar 16, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Great Ormond Street Hospital for Children NHS Foundation Trust
    CKD
    Dialysis
    calcium
    mineral and bone disorder (MBD)
    calcification
    DXA
    peripheral quantitative CT scan (pqCT)
    Additional relevant MeSH terms:
    Bone Diseases
    Chronic Kidney Disease-Mineral and Bone Disorder
    Kidney Diseases
    Renal Insufficiency, Chronic

    Study Results

    No Results Posted as of Mar 16, 2022