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ISRCTN
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ISRCTN96210443
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ClinicalTrials.gov identifier
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Public title
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15-month longitudinal study of dietary and sunlight influences on vitamin D status in a well-characterised population of postmenopausal women at 57ºN
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Scientific title
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Acronym
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ANSaVID (Aberdeen Nutrition Sunlight and VItamin D study)
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Serial number at source
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Food Standards Agency ref no: N05062
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Study hypothesis
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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).
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Ethics approval
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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).
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Study design
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Observational longitudinal study - single centre
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Low bone mass/risk of osteoporosis
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Participants - inclusion criteria
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Women from a previous sceening study (Aberdeen Prospective Osteoporosis Screening Study - APOSS) aged less than 65 years.
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Participants - exclusion criteria
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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)
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Anticipated start date
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01/01/2006
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Anticipated end date
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31/10/2008
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Status of trial
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Completed
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Patient information material
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Target number of participants
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360
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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Food Standards Agency (UK) (ref: N05062)
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Trial website
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Publications
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Contact name
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Dr
Helen
Macdonald
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Address
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Osteoporosis Research Unit
Health Sciences Building
Forestehill
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City/town
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Aberdeen
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Zip/Postcode
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AB25 2ZD
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Country
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United Kingdom
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Tel
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+44 (0)1224 559001
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Fax
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+44 (0)1224 559348
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Email
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h.macdonald@abdn.ac.uk
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Sponsor
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Food Standards Agency (UK)
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Address
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Aviation House
125 Kingsway
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City/town
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London
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Zip/Postcode
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WC2B 6NH
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Country
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United Kingdom
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Email
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saadia.noorani@foodstandards.gsi.gov.uk
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Sponsor website:
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http://www.food.gov.uk/
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Date applied
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04/09/2007
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Last edited
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16/10/2007
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Date ISRCTN assigned
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16/10/2007
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