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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Kidney Disease | This group will consist of 10 patients who have previously been diagnosed with chronic kidney disease and are receiving intravenous iron due to anaemia. | ||
| Intestinal failure | This group will consist of 10 patients who have previously been diagnosed with intestinal conditions and are receiving intravenous iron due to anaemia. | ||
| Healthy Volunteers | This group will consist of 20 healthy volunteers. This group will act as a comparator for the CKD and intestinal failure groups. |
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| Measure | Description | Time Frame |
|---|---|---|
| FGF23 levels before and after intravenous iron | Measurement of FGF23 levels in patients with CKD before and after intravenous iron administration | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| FGF23 levels in patients with CKD and healthy volunteers | Comparison of measured FGF23 levels in patients with CKD and healthy volunteers | 1 week |
| Characterisation of pre-analytical factors affecting FGF23 levels |
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Inclusion Criteria:
For Patients
For Healthy Volunteers
Exclusion Criteria:
For patients
For Healthy Volunteers
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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
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| Name | Affiliation | Role |
|---|---|---|
| Brona Roberts | Beflast Health and Social Care Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belfast Health and Social Care Trust | Belfast | United Kingdom |
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| ID | Term |
|---|---|
| D017674 | Hypophosphatemia |
| D051436 | Renal Insufficiency, Chronic |
| D007410 | Intestinal Diseases |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D051437 | Renal Insufficiency |
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Serum, EDTA plasma, and urine samples will be collected and stored for batch analysis.
To examine the effect of delayed separation and fasting vs non-fasting on FGF23 levels
| 1 week |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |