Effect of phosphate reduction on novel biomarkers & QOL Version 1.0
Research type
Research Study
Full title
To study the effect of a phosphate reduction program on novel biomarkers - (Fibroblast Growth factor - 23, Klotho) and quality of life in a group of peritoneal dialysis patients.
IRAS ID
148296
Contact name
Elaine Spalding
Contact email
Sponsor organisation
NHS Ayrshire & Arran
Research summary
High phosphate levels are a common finding in dialysis patients and associated with increased cardiovascular risk. About half of our patients have above recommended levels (1.1 -1.7mmol/L). The renal team at Crosshouse is currently implementing a quality improvement program that aims to reduce phosphate levels (to below 1.7mmol/L) and decrease pill burden.
As a part of this project we will study the effect of phosphate reduction and quality improvement program on novel laboratory tests (biochemical parameters) and quality of life. Further a database analysis will be performed comparing routine tests to the novel data collected to understand the relationship. All patients will be invited for research participation.
Methodology:
1. Analysis of Biochemical parameters - Vitamin D levels and two novel biomarkers (Fibroblast growth factor 23 (FGF-23) and Klotho) not routinely done in clinical practice. We will check the levels in blood, urine and dialysate fluid. This will be done in collaboration with Glasgow University.
2. Quality of life questionnaire survey using ’KDQOL-36™, a validated survey available as a public document and routinely used in clinical practice (http://www.rand.org/health/surveys_tools/kdqol.html). This data will be collected anonymously and will include an optional set of suggested demographic i.e. date of birth (to calculate age), sex and diagnosis for comparison of various group members.
3. Database analysis comparing the routine tests done in clinical practice i.e. Bone profile (phosphate, parathyroid hormone (PTH), calcium, alkaline phosphatase and albumin) and clinic blood pressure to the novel biomarkers.
Both the biochemical and questionnaire aspects will be performed during routine clinical interaction (further details in summary and methodology section A13). There will be no extra visits solely for purposes of research.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
14/YH/0095
Date of REC Opinion
24 Mar 2014
REC opinion
Favourable Opinion