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

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ClinicalTrials.gov Identifier: NCT03285854
Recruitment Status : Recruiting
First Posted : September 18, 2017
Last Update Posted : January 14, 2019
Sponsor:
Collaborators:
University of Kiel
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
Hannover Medical School
University Hospital Heidelberg
Cukurova University
Information provided by (Responsible Party):
Great Ormond Street Hospital for Children NHS Foundation Trust

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

Condition or disease Intervention/treatment
Chronic Kidney Disease Mineral and Bone Disorder Diagnostic Test: Collection of blood, urine and stool samples

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

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Study Type : Observational
Estimated 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 : February 1, 2017
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Calcium isotope fractionation in blood, urine and stool in healthy children and those with CKD [ Time Frame: 24 months ]
    available on request

  2. number of children with fractures, and clinical and biochemical correlates of fractures [ Time Frame: 12 months ]
    available on request

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


Biospecimen Retention:   Samples Without DNA
blood, urine, stool and dialysis fluid samples will be collected


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All children with chronic kidney disease stage 3-5 and on dialysis and age matched controls
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285854


Contacts
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Contact: Rukshana C Shroff, MD PhD +442078138513 Rukshana.Shroff@gosh.nhs.uk

Locations
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United Kingdom
Great Ormond Street Hospital for Children NHS Foundation Trust Recruiting
London, United Kingdom, WC1N 3JH
Contact: Selmy Silva    +442078138513    Selmy.Silva@gosh.nhs.uk   
Sponsors and Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust
University of Kiel
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
Hannover Medical School
University Hospital Heidelberg
Cukurova University
Investigators
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Principal Investigator: Rukshana C Shroff, MD PhD Great Ormond Street Hospital for Children NHS Foundation Trust

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Responsible Party: Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03285854     History of Changes
Other Study ID Numbers: 15HM36
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD sharing will be considered at the end of the study.

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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
DEXA
peripheral quantitative CT scan (pqCT)

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Bone Diseases
Chronic Kidney Disease-Mineral and Bone Disorder
Urologic Diseases
Renal Insufficiency
Musculoskeletal Diseases
Rickets
Bone Diseases, Metabolic
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hyperparathyroidism, Secondary
Hyperparathyroidism
Parathyroid Diseases
Endocrine System Diseases
Calcium
Calcium, Dietary
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents