An investigation of the dietary requirements for vitamin D
| ISRCTN | ISRCTN20236112 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20236112 |
| Secondary identifying numbers | N05R0003 |
- Submission date
- 20/12/2007
- Registration date
- 21/02/2008
- Last edited
- 17/10/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Kevin Cashman
Scientific
Scientific
Department of Food and Nutritional Sciences
University College Cork
Cork
N/A
Ireland
Study information
| Study design | Double blinded randomised placebo controlled intervention study - multicentre collaboration (University of Ulster and University College Cork) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Dietary requirements for vitamin D: an investigation of the relative significance of dietary intake and sunlight on vitamin D status in young and elderly adults |
| Study objectives | We hypothesise that additional dietary vitamin D is required to prevent nutritional deficiency during winter in young and elderly adults. |
| Ethics approval(s) | Ethics approval received from the University of Ulster Research Ethics Committee on the 22nd March 2006 (ref: REC/06/13) |
| Health condition(s) or problem(s) studied | Dietary vitamin D intake and status |
| Intervention | Oral daily supplementation with vitamin D3 of the following doses: 1. Placebo (no treatment) 2. 5 mcg 3. 10 mcg 4. 15 mcg Supplementation is provided for six months from October to March. There is no additional follow-up. However there is a run-in phase during the preceding summer when participants are asked to keep a diary of sun exposure and activities outdoors. This is assessed in July and August. |
| Intervention type | Supplement |
| Primary outcome measure | 1. Serum 25 hydroxyvitamin D concentrations 2. Serum parathyroid hormone concentrations 3. Serum calcium concentrations 4. Dietary calcium and vitamin D intakes (from four-day food diary and food frequency questionnaire) |
| Secondary outcome measures | 1. Bone mineral density (from dual energy x-ray absorptiometry [DXA] scan of spine, hip and whole body) 2. Body composition measurements 3. Immune markers 4. Bone turnover markers |
| Overall study start date | 01/04/2006 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 240 from Coleraine and 240 from Cork |
| Key inclusion criteria | 1. Consenting adult men and women 2. Aged 20 - 85 years 3. In general good health |
| Key exclusion criteria | 1. Severe medical illness 2. Hypercalcaemia 3. Known intestinal malabsorption syndrome 4. Excessive alcohol use 5. Those who took medications known to interfere with vitamin D metabolism 6. Pregnancy or planning to become pregnant during the six months of the intervention 7. Those taking high dose vitamin D-containing supplements for three months before initiation of study 8. Those who over the six-month course of intervention are planning a winter vacation to a location at which either the altitude or the latitude would be predicted to result in significant cutaneous vitamin D synthesis from solar radiation (e.g., a mountain ski resort or a winter sun coastal resort) |
| Date of first enrolment | 01/04/2006 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Department of Food and Nutritional Sciences
Cork
N/A
Ireland
N/A
Ireland
Sponsor information
Food Standards Agency (UK)
Government
Government
UK Headquarters
Aviation House
125 Kingsway
London
WC2B 6NH
United Kingdom
| Website | http://www.food.gov.uk |
|---|---|
"ROR" |
https://ror.org/05p20a626 |
Funders
Funder type
Government
Food Standards Agency (UK) (ref: N05R0003)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- The Food Standards Agency, FSA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2009 | Yes | No | |
| Results article | results | 01/03/2011 | Yes | No | |
| Results article | results | 01/08/2012 | Yes | No |
