| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN96210443 |
| Date ISRCTN assigned | 16/10/2007 |
| Local reference number(s) | Food Standards Agency ref no: N05062 |
| Public title | 15-month longitudinal study of dietary and sunlight influences on vitamin D status in a well-characterised population of postmenopausal women at 57ºN |
| Scientific title |
|
| Acronym | ANSaVID (Aberdeen Nutrition Sunlight and VItamin D study) |
| Disease/condition/study domain | Low bone mass/risk of osteoporosis |
| Study hypothesis | To establish whether diet and previous summer's sunlight exposure maintain vitamin D levels at northerly latitudes of the United Kingdom (UK) and determine how much dietary vitamin D is required (if any). |
| Design/methodology | Observational longitudinal study - single centre |
| Research ethics review | Approval received from the National Health Service Research Ethics Committee (NHS REC): Grampian Local Research Ethics Committee on the 13th January 2006 (ref: 05/S0802/149). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Women from a previous sceening study (Aberdeen Prospective Osteoporosis Screening Study - APOSS) aged less than 65 years. |
| Participants - exclusion criteria | Participants will be excluded if they:
1. Have chronic gastro-intestinal disease associated with malabsorption
2. Are taking oral corticosteroids
3. Are receiving bisphosphonate therapy (as there is a possibility of interaction with vitamin D metabolism) |
| Patient information material |
|
| Anticipated start date | 01/01/2006 |
| Anticipated end date | 31/10/2008 |
| Status of trial | Ongoing |
| Target number of participants | 360 |
| Interventions | This is a 15-month observational study starting in March 2006 aiming to assess how diet and sunlight exposure influence vitamin D status for each three-monthly season. There will be five visits in total.
All women will complete food diaries, sunlight exposure and falls diaries, physical activity questionnaires, and have grip strength assessed at three-month intervals (five visits in total) and wear sunlight exposure badges for one week every three months. There will also be a quantitative measure of sunlight exposure using a hand held spectrophotometer/chromometer which measures skin colouration. At each visit the women will be asked if they will provide a blood sample for measurement of 25-hydroxy vitamin D (a marker of vitamin D status) and bone turnover markers. All women will be offered two bone mineral density scans: the first in the autumn and the second the following spring.
A subgroup of women (n = 48) will use accelerometers for one week every three months to estimate physical activity in more detail. |
| Primary outcome measure(s) | Monitor longitudinally the seasonal variation in vitamin D status at a northerly latitude, assessing the individual contributions of sunlight and diet.
All primary and secondary outcomes were measured at each visits, i.e., at Baseline (BL), 3-month, 6-month, 9-month and 12-month visits. |
| Secondary outcome measure(s) | 1. Monitor seasonal variation in physical activity (confounder of vitamin D status)
2. Monitor seasonal variation in:
2.1. Markers of bone turnover (functional marker)
2.2. Falls, muscle strength (functional markers not related to bone health)
3. Determine the relationship between vitamin D status, functional markers (Bone Mineral Density [BMD], bone resorption, muscle strength) with and without adjustment for physical activity level
All primary and secondary outcomes were measured at each visits, i.e., at Baseline (BL), 3-month, 6-month, 9-month and 12-month visits; BMD was measured at 6-month and 9-month visits only. |
| Sources of funding | Food Standards Agency (UK) (ref: N05062) |
| Sponsor name | Food Standards Agency (UK) |
| Sponsor details | Aviation House
125 Kingsway
London
United Kingdom
WC2B 6NH |
| Sponsor email | saadia.noorani@foodstandards.gsi.gov.uk |
| Sponsor website | http://www.food.gov.uk/ |
| Contact name | Dr Helen Macdonald |
| Contact details | Osteoporosis Research Unit
Health Sciences Building
Forestehill
Aberdeen
United Kingdom
AB25 2ZD |
| Contact telephone | +44 (0)1224 559001 |
| Contact fax | +44 (0)1224 559348 |
| Contact email | h.macdonald@abdn.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN96210443 |
| Date last extracted from ISRCTN register | 17/04/2008 |
