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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24041337
Publication citations
-
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
- ISRCTN35648481 _PIS_22Aug12_V3.pdf Uploaded 07/04/2017