|
Welcome
|
|
04 February 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| An investigation of the dietary requirements for vitamin D |
| ISRCTN | ISRCTN20236112 |
| ClinicalTrials.gov identifier | |
| Public title | An investigation of the dietary requirements for vitamin D |
| 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 |
| Acronym | N/A |
| Serial number at source | N05R0003 |
| Study hypothesis | We hypothesise that additional dietary vitamin D is required to prevent nutritional deficiency during winter in young and elderly adults. |
| Lay summary | |
| Ethics approval | Ethics approval received from the University of Ulster Research Ethics Committee on the 22nd March 2006 (ref: REC/06/13) |
| Study design | Double blinded randomised placebo controlled intervention study - multicentre collaboration (University of Ulster and University College Cork) |
| Countries of recruitment | Ireland |
| Disease/condition/study domain | Dietary vitamin D intake and status |
| Participants - inclusion criteria |
1. Consenting adult men and women
2. Aged 20 - 85 years 3. In general good health |
| Participants - 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) |
| Anticipated start date | 01/04/2006 |
| Anticipated end date | 31/12/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 240 from Coleraine and 240 from Cork |
| Interventions |
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. |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding | Food Standards Agency (UK) (ref: N05R0003) |
| Trial website | |
| Publications |
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19297462
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21270359 |
| Contact name | Prof Kevin Cashman |
| Address |
Department of Food and Nutritional Sciences
University College Cork |
| City/town | Cork |
| Zip/Postcode | N/A |
| Country | Ireland |
| Sponsor | Food Standards Agency (UK) |
| Address |
UK Headquarters
Aviation House 125 Kingsway |
| City/town | London |
| Zip/Postcode | WC2B 6NH |
| Country | United Kingdom |
| Sponsor website: | http://www.food.gov.uk |
| Date applied | 20/12/2007 |
| Last edited | 27/04/2011 |
| Date ISRCTN assigned | 21/02/2008 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|