Condition category
Musculoskeletal Diseases
Date applied
27/03/2017
Date assigned
03/04/2017
Last edited
06/11/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Vitamin D is essential for good health, because it helps our bodies to absorb calcium from the diet. There is a lot of evidence that having enough vitamin D can help prevent many diseases, such as heart disease, bone diseases and cancer. Although vitamins generally come from the diet, in the case of vitamin D, the majority of people actually get most of it from sunlight. Vitamin D deficiency or insufficiency is common in adults in the UK, particularly during the winter months where over 50% of adults are thought to have low Vitamin D levels. There is evidence that patients who are having knee or hip replacement surgery who have low vitamin D levels could have a poorer outcome and a longer stay in hospital. This study is looking at whether checking patient's Vitamin D levels before they have surgery can help to improve outcomes. 180,000 total hip or knee replacement procedures are performed each year in the UK and so if a link exists, the benefits of screening may be significant, as these deficient patients could start taking supplements to correct the deficiency before surgery until six months afterwards in order to improve outcomes.

Who can participate?
Adults who are scheduled to have hip or knee replacement surgery

What does the study involve?
Patients have their vitamin D levels measured at the beginning of the study. Those who are found to have low vitamin D levels are then randomly allocated into one of two groups. Those in the first group receive Vitamin D supplementation before surgery until six months after surgery, and those in the second group receive no vitamin D supplements. Participants in both groups are followed up using questionnaires six months after their surgery and have their medical records reviewed in order to assess how well they have recovered.

What are the possible benefits and risks of participating?
There are no direct benefits from taking part in the study, as currently it is not known whether screening and then treating Vitamin D deficiency before surgery is beneficial. However, it is hoped that the information from the study will help future patients having hip or knee replacement. There are no notable risks involved with participating.

Where is the study run from?
Five NHS hospitals in the north of England (UK)

When is the study starting and how long is it expected to run for?
January 2016 to November 2018

Who is funding the study?
Orthopaedic Research UK (UK)

Who is the main contact?
Dr Rory Morrison
rorymorrison@nhs.net

Trial website

N/A

Contact information

Type

Scientific

Primary contact

Mr Rory Morrison

ORCID ID

Contact details

North Tyneside General Hospital
Rake Lane
North Shields
NE63 9JJ
United Kingdom
+44 (0)1670 564132
rorymorrison@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33969

Study information

Scientific title

A prospective, randomised-controlled feasibility study investigating the benefit of screening for Vitamin D deficiency in a pre-operative elective arthroplasty setting

Acronym

VASO

Study hypothesis

A vitamin D level below normal (hypovitaminosis D or Vitamin D insufficiency/deficiency) is linked to a poorer outcome whereas a normal level is linked to an improved outcome following primary, elective hip or knee arthroplasty.

Ethics approval

Yorkshire and The Humber - Bradford Leeds Research Ethics Committee, 13/03/2017, ref: 17/YH/0067

Study design

Randomised; Interventional; Design type: Treatment, Screening, Drug

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Musculoskeletal disorders, Primary sub-specialty: Other; UKCRC code/ Disease: Musculoskeletal/ Other osteopathies

Intervention

All patients in this feasibility trial will have their Vitamin D level checked before surgery, on the day of surgery and at 6 months after surgery. Those patients who, before their operation, are found to have a Vitamin D level below normal will be randomised to one of two groups.

Intervention group: Participants receive Vitamin D supplementation each day before surgery and for 6 months following surgery. The dosage of Vitamin D given is dependent on the patient’s levels.
Deficiency (<25nmol/L): 20,000 units orally twice per week for 8 weeks then 1,600 units orally daily until 6 months following surgery
Insufficiency (25-49nmol/L): 1,600 units orally daily until 6 months following surgery.
Vitamin D levels are rechecked day of surgery and at 6-months following surgery

Control group: Participants receive no supplementation.

Participants are followed up six months post-surgery via questionnaires and medical record review.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

1. Pain and function is measured using the Oxford hip or knee score, collected by written questionnaire at baseline and 6 months
2. Health-related quality of life is measured using the EQ-5D collected by written questionnaire at baseline and 6 months

Secondary outcome measures

1. Length of hospital stay is collected from medical notes at endline
2. Medical complications including superficial and deep infection are collected from medical notes at endline
3. Readmission rates within 30 days of primary surgery are collected from medical notes at endline
4. Return to theatre rate within 30 days is collected from medical notes at endline
5. Mortality at 90-days is collected from medical notes at endline

Overall trial start date

03/01/2016

Overall trial end date

30/11/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients scheduled for primary total hip or knee arthroplasty
2. Aged over 18
3. Presenting at a participating trial site

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 100; UK Sample Size: 100

Participant exclusion criteria

1. Lack of mental capacity to understand/comply with study procedures
2. Revision surgery
3. Known contraindication to Vitamin D treatment, e.g. previous diagnosis of sarcoidosis, primary hyperparathyroidism or other hypercalcaemic disorders, allergy
4. Renal impairment with eGFR <30 mL/minute
5. Already taking a Vitamin D supplement

Recruitment start date

04/05/2017

Recruitment end date

30/06/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wansbeck General Hospital
Woodhorn Lane
Ashington
NE63 9JJ
United Kingdom

Trial participating centre

North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom

Trial participating centre

Hexham General Hospital
Corbridge Road
Hexham
NE46 1QJ
United Kingdom

Trial participating centre

James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Trial participating centre

The Friarage Hospital
Northallerton
DL6 1JG
United Kingdom

Sponsor information

Organisation

Northumbria Healthcare NHS Foundation Trust

Sponsor details

North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom
+44 (0)191 293 4087
ResearchAndDevelopment@northumbria-healthcare.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Orthopaedic Research UK

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal and presentation at relevant scientific meetings.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/11/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29096686

Publication citations

Additional files

Editorial Notes

06/11/2017: Publication reference added. 08/05/2017: The recruitment start date has been updated from 24/04/2017 to 04/05/2017. 18/04/2017: The recruitment start date has been updated from 16/04/2017 to 24/04/2017.