Investigation of Hypophosphataemia Following Intravenous Iron

Investigation of the Mechanisms for the Development of Hypophosphataemia Following Administration of Intravenous Iron in Patients With Severe Anaemia

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Diseases; Anemia; Hypophosphatemia; Intestinal Disease

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• United Kingdom
  • Belfast, United Kingdom
    • Belfast Health and Social Care Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

For Patients

• aged 18 years or older
• previously diagnosed with intestinal failure or advanced CKD
• have anaemia requiring administration of intravenous iron
• be able to adequately speak and understand English
• Have capacity to give written informed consent

For Healthy Volunteers

• aged 18 years or more
• be able to adequately speak and understand English
• have capacity to give written informed consent

Exclusion Criteria:

For patients

• have dialysis-dependent CKD
• participation in any other study which will affect results of the current study

For Healthy Volunteers

• have CKD (eGFR <60 mls/min/1.73^2)
• history of any form of metabolic bone disease
• Participation in any other study which will affect the results of the current study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	To examine the effect of delayed separation and fasting vs non-fasting on FGF23 levels	1 week

Collaborators and Investigators

• Sponsor: Belfast Health and Social Care Trust
• Investigators: Principal Investigator: Brona Roberts, Beflast Health and Social Care Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 6, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Urologic Diseases; Hematologic Diseases; Gastrointestinal Diseases; Renal Insufficiency; Phosphorus Metabolism Disorders; Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Intestinal Diseases; Hypophosphatemia
• Other Study ID Numbers: 18195BR-SS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No