Vitamin D in older people
| ISRCTN | ISRCTN35648481 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35648481 |
| EudraCT/CTIS number | 2011-004890-10 |
| Secondary identifying numbers | 12356 |
- Submission date
- 16/08/2012
- Registration date
- 16/08/2012
- Last edited
- 29/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
Newcastle Clinical Trials Unit
Newcastle University
1-4 Claremont Terrace
Newcastle Upon Tyne
NE2 4AE
United Kingdom
| Phone | +44 191 208 2524 |
|---|---|
| alexander.von-wilamowitz-moellendorff@newcastle.ac.uk |
Study information
| Study design | Randomised interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | ISRCTN35648481 _PIS_22Aug12_V3.pdf |
| Scientific title | Optimising Vitamin D Status in Older People: A Randomised Controlled Trial of Vitamin D Supplementation |
| Study acronym | VDOP |
| Study objectives | 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(s) | NRES Committee North East – Sunderland, 13/04/2012, ref: 12/NE/0050 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Change in BMD at the hip (total hip BMD) |
| Secondary outcome measures | Changes in achieved plasma 250HD |
| Overall study start date | 01/10/2012 |
| Completion date | 06/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | UK Sample Size: 375 |
| Total final enrolment | 379 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 08/11/2012 |
| Date of final enrolment | 06/06/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NE2 4HH
United Kingdom
Sponsor information
Hospital/treatment centre
Level 1 Regent Point
Regent Farm Road
Gosforth
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom
| Phone | +44 191 282 4518 |
|---|---|
| Trust.R&D@nuth.nhs.uk | |
| Website | http://www.newcastle-hospitals.org.uk/ |
"ROR" |
https://ror.org/01kj2bm70 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 17/09/2013 | Yes | No | |
| Participant information sheet | version V3 | 22/08/2012 | 07/04/2017 | No | Yes |
| Results article | results | 01/01/2019 | 10/01/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN35648481 _PIS_22Aug12_V3.pdf
- Uploaded 07/04/2017
Editorial Notes
29/08/2019: The total final enrolment was added.
10/01/2019: Publication reference added.
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.
