End stage renal disease Urological and Genital Diseases End stage renal disease
Conditions
Interventions
Participants are randomly allocated to one of two groups.
Intervention group: Participants will receive oral cholecalciferol 60,000IU fortnightly for the duration of the trial mean follow-up 5.5 year
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over 2. Have given written informed consent to participate 3. UK Resident 4. Have dialysis-requiring end stage renal disease (ESRD)
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 23/11/2017: 1. Current treatment with high dose (>1,000IU/day) cholecalciferol or ergocalciferol in the last 30 days 2. Persistent hypercalcaemia (>2.62 mmol/l on three separate and sequential occasions without precipitating cause) 3. Life expectancy of less than 6 months 4. Women who are pregnant / planning to become pregnant 5. Hypersensitivity to colecalciferol or any of the excipients 6. Not contributing, or willing to contribute, data to the UK Renal Registry (UKRR) Previous exclusion criteria: 1. Current treatment with high dose (>1,000IU/day) cholecalciferol 2. Persistent hypercalcaemia (>2.62 mmol/l on three separate and sequential occasions without precipitating cause) 3. Life expectancy of less than 6 months 4. Women who are pregnant / planning to become pregnant 5. Inability to provide informed consent 6. Not contributing, or willing to contribute, data to the UK Renal Registry (UKRR)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All cause mortality will be determined from the national deaths register at 7 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health-related quality of life is measured using the EQ5D questionnaire , determined at 6-monthly intervals for the duration of the trial 2. Hospitalisation-requiring composite cardiovascular events (defined as CV death, acute coronary syndrome, heart failure or arrhythmia and stroke) is determined from Hospital Episode Statistics, and will be obtained at at least 6-monthly intervals for the duration of the trial 3. Hospitalisation for infection is determined from Hospital Episode Statistics, and will be obtained at at least 6-monthly intervals for the duration of the trial 4. Cancer incidence determined from the UK and Ireland Association of Cancer Registries (UKIACR) database after the end of the trial (after 2,200 deaths have occurred, estimated to be 7 years after enrolment of the first participant) 5. Hospitalisation for fracture is determined from Hospital Episode Statistics, and will be obtained at at least 6-monthly intervals for the duration of the trial 6. Cost-effectiveness of cholecalciferol is determined by calculating life years gained per patient (estimated from mortality data from the National Deaths Register (ONS) and Quality Adjusted Life Years (QALYs) gained (estimated from both ONS mortality data and EQ5D data converted to health state utilities relevant to the UK population) at 7 years | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed