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| Mechanisms by which fruit and vegetables influence postmenopausal bone health: a randomised controlled trial in a well-characterised population |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN86186352 |
| Date ISRCTN assigned | 30/04/2007 |
| Local reference number(s) | FSA project number: N05043 |
| Public title | Mechanisms by which fruit and vegetables influence postmenopausal bone health: a randomised controlled trial in a well-characterised population |
| Scientific title | |
| Acronym | ADAFVT (Aberdeen Dietary Acidity, Fruit and Vegetable Trial) |
| Disease/condition/study domain | Low bone mass/risk of osteoporosis |
| Study hypothesis | To test whether fruit and vegetable intake reduces the acidity of a mixed diet and the requirement of bone for buffering, or provide other dietary components important for bone health. |
| Design/methodology | Two year placebo-controlled randomised trial (double blind for potassium citrate arms and single blind for fruit and vegetable arm). |
| Research ethics review | Ethical permission was obtained from Grampian Research Ethics Committee on the 23rd December 2002 (ref: 02/0053). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Women aged 55 years to 65 years who had taken part in a longitudinal study (Aberdeen Prospective Osteoporosis Screening Study). Includes: 1. Otherwise healthy women taking other types of diuretics (not potassium sparing diuretics) or hypertension tablets 2. Women on thyroxine treatment provided their thyroid function is stable (as assessed by free Thyroxine [T4] and Thyroid Stimulating Hormone [TSH] levels) and their dose had not changed in the year prior to study entry |
| Participants - exclusion criteria | 1. Suffering from severe disease 2. Malabsorption 3. Having difficulties swallowing tablets/capsules 4. Taking oral corticosteroids 5. On or past bisphosphonate treatment (more than a few weeks) 6. Taking Hormone Replacement Therapy (HRT) in the last six months 7. Less than five years past the menopause 8. Currently taking potassium-sparing diuretics 9. Osteoporosis diagnosed from Dual Energy X-ray Absorptiometry (DEXA) scan at baseline visit |
| Patient information material | |
| Anticipated start date | 01/03/2003 |
| Anticipated end date | 01/12/2005 |
| Status of trial | Completed |
| Target number of participants | 260 |
| Interventions | Minimisation criteria included key genotypes (vitamin D receptor genotype and Apolipoprotein E genotype, smoking and dietary acidity (calculated from protein to potassium ratio). Group A: potassium citrate equivalent to 900 g fruit and vegetables (55.5 mEq) Group B: potassium citrate equivalent to 300 g fruit and vegetables (18.5 mEq) Group C: 300 g of fruit and vegetables Group D: placebo Duration of treatment was two years for each treatment arm. |
| Primary outcome measure(s) | 1. Bone turnover markers: a. serum N-terminal Propeptide of type 1 collagen (P1NP), measured at baseline, 3, 6, 12, 18 and 24 months b. serum C-terminal telopeptide of type I collagen (CTX), measured at baseline, 3, 6, 12, 18 and 24 months c. urinary free Deoxypyridinoline cross-links (fDPD), measured at baseline, 3, 6, 12, 18 and 24 months; women also posted a fasted urine sample 6 to 8 weeks after the baseline visit |
| Secondary outcome measure(s) | Bone mineral density change over two years measured by DEXA at baseline and 24 months. |
| Sources of funding | Food Standards Agency (UK) |
| Sponsor name | Food Standards Agency (UK) |
| Sponsor details | Aviation House 125 Kingsway London United Kingdom WC2B 6NH |
| Sponsor email | alisdair.wotherspoon@foodstandards.gsi.gov.uk |
| Sponsor website | http://www.food.gov.uk |
| Contact name | Dr Helen Macdonald |
| Contact details | Osteoporosis Research Unit Health Sciences Building University of Aberdeen Osteoporosis Research Unit Foresterhill 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 | ISRCTN86186352 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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