atural vitamin D (cholecalciferol) versus standard care in patients receiving dialysis

Phase 4

• Conditions: End stage renal disease; Urological and Genital Diseases

• Registration Number: ISRCTN15087616
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

2015 presented at 3rd International Clinical Trials Methodology Conference in http://doi.org/10.1186/1745-6215-16-S2-O15 (added 10/05/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-30
• Last Update Posted: 24 May 2021
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 4200

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified