Condition category
Musculoskeletal Diseases
Date applied
16/08/2012
Date assigned
16/08/2012
Last edited
07/04/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Vitamin D is essential for healthy bones and muscles, particularly in older people where low levels contribute to weak bones and falls. Although vitamins generally come from the diet, in the case of vitamin D, the majority of people actually get most of it from sunlight. Almost every cell in the body contains a vitamin D receptor that is vital for a variety of functions. Low vitamin D therefore can prevent tissues from carrying out their normal functions, which can lead to a range of long-term health conditions, such as weak bones, heart disease and problems with the immune system. People over the age of 70 slowly lose bone density over time, and vitamin D may help to slow this loss down. The aim of this study is to look at the effectiveness of three doses of vitamin D supplementation to prevent bone loss, given each month for a year on the change in bone density in older adults at risk of vitamin D deficiency.

Who can participate?
Men and women aged 70 years and over who are living in the community and are able to walk.

What does the study involve?
Participants are randomly allocated to one of three groups. Each group are given vitamin D supplements to take at different doses. The supplement is in the form of oil which is taken by mouth. There are six study visits during the study, two at the start, then every three months until the last visit at one year later, where participants are given the study supplement, have a blood test taken, and provide a urine sample. Before these visits, participants are asked not to eat anything after 10pm the night before. Participants also undergo two Dexa scans, which measure done density and complete questionnaires about diet and health, quality of life and a sunshine exposure.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Newcastle University (UK)

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

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

Who is the main contact?
Dr Alexander von Wilamowitz-Moellendorff
alexander.von-wilamowitz-moellendorff@newcastle.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alexander von Wilamowitz-Moellendorff

ORCID ID

Contact details

Newcastle Clinical Trials Unit
Newcastle University
1-4 Claremont Terrace
Newcastle Upon Tyne
NE2 4AE
United Kingdom
+44 191 208 2524
alexander.von-wilamowitz-moellendorff@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

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.

Ethics approval

NRES Committee North East – Sunderland, 13/04/2012, 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

See additional files

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 which is equivalent to 10 mcg /day
Group 2: Oral vitamin D3 – 24,000 IU once monthly which is equivalent to 20 mcg /day
Group 3: Oral vitamin D3 – 48,000 IU once monthly which is equivalent to 40 mcg /day

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

06/06/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Inclusion criteria as of 07/04/2017:
1. Ambulant, community dwelling men and women aged 70 years and above (by end April2013)
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

Original 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

Exclusion criteria as of 07/04/2017:
1. Current antiresorptive or anabolic treatment for osteoporosis
2. Treatment with bisphosphonates for osteoporosis in past two years
3. Current supplement 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 hyperparathyroidism
6. Hypercalcaemia (albumin-adjusted plasma calcium > 2.60 mmol/l)
7. Renal impairment (Stage 4-5 Chronic Kidney Disease: eGFR < 30 ml/min/1.73m2)
8. History of renal stones

Original 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

08/11/2012

Recruitment end date

06/06/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newcastle University
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Organisation

Newcastle Joint Research Office

Sponsor details

Level 1 Regent Point
Regent Farm Road
Gosforth
Newcastle Upon Tyne
NE1 4LP
United Kingdom
+44 191 282 4518
Trust.R&D@nuth.nhs.uk

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

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The study results will be published in peer reviewed journals and presented at scientific conferences. A lay summery of the main findings will be circulated to all trial participants.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study is not expected to be made available due to lack of consent from trial participants for sharing of trial data. A formal request may be made to the Chief Investigator and following ethical approval via a proportionate review from a UK-REC data may be shared with non-collaborators.

Intention to publish date

31/12/2018

Participant level data

Not expected to be available

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

07/04/2017: The following changes have been made to the record: 1. The study contact has been updated from Christine Harle to Alexander von Wilamowitz-Moellendorff 2. The recruitment dates have been updated from 01/10/2012 - 30/04/2013 to 08/11/2012 - 06/06/2014 and the overall trial end date has been updated from 30/04/2013 to 06/06/2014 3. The inclusion criteria and exclusion criteria have been updated 4. A plain English summary has been added 5. The publication and dissemination plan and IPD sharing plan have been added 6. The participant information sheet has been uploaded.