Condition category
Musculoskeletal Diseases
Date applied
16/08/2012
Date assigned
16/08/2012
Last edited
18/09/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Christine Harle

ORCID ID

Contact details

Newcastle University
William Leech Building
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom
christine.harle@newcastle.ac.uk

Additional identifiers

EudraCT number

2011-004890-10

ClinicalTrials.gov number

Protocol/serial number

12356

Study information

Scientific title

Optimising Vitamin D Status in Older People: A Randomised Controlled Trial of Vitamin D Supplementation

Acronym

VDOP

Study hypothesis

Vitamin D insufficiency is common in older people, where it may lead to an increase in bone breakdown, resulting in bone loss as well as impairment of muscle function and an increased risk of falls and fractures.

This is a non-commercial single centre study to determine the efficacy of three doses of vitamin D supplementation to prevent bone loss, given each month for a year on the change in Bone Mineral Density (BMD) in subjects aged 70 years or older, at risk of vitamin D deficiency.

We aim to establish the effects of three doses of vitamin D supplement, given for 12 months on the change in BMD.

The effects of the supplement and blood levels of vitamin D (plasma 25OHD concentration) on parathyroid hormone levels and a number of other biochemical markers of bone metabolism, will also be examined which will give insights into bone health and risk of fracture.

The doses used are consistent with current UK guidance and the most recent review performed by the Institute of Medicine, in North America and Canada for adults in this age group. The study offers the opportunity to evaluate the impact of dosage of vitamin D supplement on structural (DXA Scanning) and biochemical markers in order to prevent bone loss and to determine an adequate vitamin D intake to maintain bone health.

Ethics approval

First MREC, 13 April 2012 ref: 12/NE/0050

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

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

Condition

Musculoskeletal diseases

Intervention

375 participants will be recruited from GP practices from the Newcastle area (within the Primary Care Research Network – Northern & Yorkshire) and will be randomised into one of 3 groups as described below. Participants will be given double-blind study supplement and asked to attend the Clinical Ageing Research Unit (CARU) for a total of 6 visits.

Participants will be randomised into the following groups:
Group 1: Oral vitamin D3 12,000 IU once monthly (equivalent to 400 IU /day)
Group 2: ; Follow Up Length: 12 month(s); Study Entry : Single Randomisation only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Change in BMD at the hip (total hip BMD)

Secondary outcome measures

Changes in achieved plasma 250HD

Overall trial start date

01/10/2012

Overall trial end date

30/04/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Ambulant, community dwelling men and women aged 70 years and above
2. Individuals capable of giving informed consent on their own behalf
3. Individuals willing to attend the Study Centre (CARU) on six occasions and to be contacted by telephone at monthly intervals between study visits over twelve months
4. Male and female participants
5. > 70 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 375

Participant exclusion criteria

1. Current antiresorptive or anabolic treatment for osteoporosis.
2. Treatment with bisphosphonates for osteoporosis in past two years.
3. Current use of vitamin D (>400 IU/day) or calcium (>500 mg/day) (including use of over-the-counter preparations).
4. Fragility fracture in the previous six months.
5. Known primary hyperparathyroisism.
6. Hypercalcaemia (albumin-adjusted plasma calcium > 2.60 mmol/l).
7. Renal impairment (Stage 4-5 Chronic Kidney Disease: GFR < 30 ml/min/1.73m2).
8. History of renal stones.
9. Peanut allergy

Recruitment start date

01/10/2012

Recruitment end date

30/04/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newcastle University
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.newcastle-hospitals.org.uk/

Funders

Funder type

Charity

Funder name

Arthritis Research (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24041337

Publication citations

  1. Protocol

    Schoenmakers I, Francis RM, McColl E, Chadwick T, Goldberg GR, Harle C, Yarnall A, Wilkinson J, Parker J, Prentice A, Aspray T, Vitamin D supplementation in older people (VDOP): Study protocol for a randomised controlled intervention trial with monthly oral dosing with 12,000 IU, 24,000 IU or 48,000 IU of vitamin D₃., Trials, 2013, 14, 299, doi: 10.1186/1745-6215-14-299.

Additional files

Editorial Notes