Calcium Balance Studies in Children With CKD and on Dialysis (NCT03285854) | Clinical Trial Compass
UnknownNot Applicable
Calcium Balance Studies in Children With CKD and on Dialysis
United Kingdom120 participantsStarted 2017-02-01
Plain-language summary
This is a novel, non-invasive method of assessing Ca balance by natural Ca isotope fractionation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Calcium isotope fractionation in blood, urine and stool in healthy children and those with CKD
Timeframe: 24 months
2
number of children with fractures, and clinical and biochemical correlates of fractures
Timeframe: 12 months
3
Bone scans - whole body & lumbar spine DEXA, bone mineral density on tibial peripheral quantitative CT scan
Timeframe: 24 months
Trial details
NCT IDNCT03285854
SponsorGreat Ormond Street Hospital for Children NHS Foundation Trust