An observational study in Hypophosphatemia, Chronic Kidney Diseases and Intestinal Disease, sponsored by Belfast Health and Social Care Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-06.
Sponsored by Belfast Health and Social Care Trust · Observational
Anaemia (low haemoglobin levels) can develop in a number of conditions, including chronic kidney disease (CKD) and intestinal conditions (e.g. inflammatory bowel disease, intestinal failure). Intravenous iron can be given to patients with these conditions to help correct their aneaemia. However, intravenous iron has been associated with the development of low phosphate levels - hypophophosphataemia. The aim of this study is to determine potential causes of hypophosphataemia following administration of intravenous iron.
Low levels of iron can lead to anaemia, known as iron deficiency anaemia, which can be debilitating due to symptoms such as shortness of breath, fatigue, and dizziness. Iron deficiency anaemia can be treated by giving iron supplementation. Iron supplements can be taken orally or can be given intravenously (through the veins). Giving iron intravenously has advantages over iron supplements taken orally, which can cause side effects such as stomach pain and cramping. However, giving iron intravenously has been associated with the development of low levels of phosphate in the blood. This is known as hypophosphataemia. Phosphate is an important salt in the body and has a number of important functions. Very low levels of phosphate can cause muscle pain, disorientation, seizures and heart problems. It is unclear why giving iron intravenously can cause hypophosphataemia. This project aims to investigate the potential causes of hypophosphataemia in patients who receive intravenous iron as treatment for anaemia associated with their condition. Patients with chronic kidney disease (CKD) and intestinal failure will be recruited to the study, since people with CKD may handle iron differently than those with healthy kidneys. Samples will be taken at two time points: prior to giving the intravenous iron and at the patient's next appointment. Healthy volunteers will also be recruited to the study to allow comparison between the groups receiving iron and those who do not receive iron. Samples will be analysed to determine potential causes of hypophosphataemia. Results from before and after iron is given will be compared to determine if any of the participants developed hypophosphataemia and if any other test are affected which may explain why this has developed.
53 studies on the registry are indexed under Hypophosphatemia; 16 are open to participants now.
This study's planned enrollment of 40 is below the median of 105 across 26 observational studies indexed under Hypophosphatemia.
Browse Hypophosphatemia studies →Belfast Health and Social Care Trust is the lead sponsor of 45 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with intestinal failure or CKD will be recruited from iron infusion clinics, which are based in secondary care. Healthy Volunteers will be recruited from laboratory staff from within the Belfast Health and Social Care Trust
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For Patients
For Healthy Volunteers
Exclusion Criteria:
For patients
For Healthy Volunteers
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will consist of 10 patients who have previously been diagnosed with chronic kidney disease and are receiving intravenous iron due to anaemia.
This group will consist of 10 patients who have previously been diagnosed with intestinal conditions and are receiving intravenous iron due to anaemia.
This group will consist of 20 healthy volunteers. This group will act as a comparator for the CKD and intestinal failure groups.
FGF23 levels before and after intravenous iron
Measurement of FGF23 levels in patients with CKD before and after intravenous iron administration
Time frame: 8 weeks
FGF23 levels in patients with CKD and healthy volunteers
Comparison of measured FGF23 levels in patients with CKD and healthy volunteers
Time frame: 1 week
Characterisation of pre-analytical factors affecting FGF23 levels
To examine the effect of delayed separation and fasting vs non-fasting on FGF23 levels
Time frame: 1 week
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2019 (actual). Primary completion is estimated for Dec 2020, 14 months after the start.
Of 14 observational studies under Hypophosphatemia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's planned 14 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Belfast Health and Social Care Trust