%0 Journal Article %T Trials and tribulations of recruiting 2,000 older women onto a clinical trial investigating falls and fractures: Vital D study %A Kerrie M Sanders %A Amanda L Stuart %A Elizabeth N Merriman %A Meaghan L Read %A Mark A Kotowicz %A Doris Young %A Roderick Taylor %A Ian Blair-Holt %A Alistair G Mander %A Geoffrey C Nicholson %J BMC Medical Research Methodology %D 2009 %I BioMed Central %R 10.1186/1471-2288-9-78 %X The Vital D Study recruited older women identified at high risk of fracture through the use of an eligibility algorithm, adapted from identified risk factors for hip fracture. Participants were randomised to orally receive either 500,000 IU vitamin D3 (cholecalciferol) or placebo every autumn for five consecutive years. A variety of recruitment strategies were employed to attract potential participants.Of the 2,317 participants randomised onto the study, 74% (n = 1716/2317) were consented onto the study in the last five months of recruiting. This was largely due to the success of a targeted mail-out. Prior to this only 541 women were consented in the 18 months of recruiting. A total of 70% of all participants were recruited as a result of targeted mail-out. The response rate from the letters increased from 2 to 7% following revision of the material by a public relations company. Participant demographic or risk factor profile did not differ between those recruited by targeted mail-outs compared with other methods.The most successful recruitment strategy was the targeted mail-out and the response rate was no higher in the local region where the study had extensive exposure through other recruiting strategies. The strategies that were labour-intensive and did not result in successful recruitment include the activities directed towards the GP medical centres. Comprehensive recruitment programs employ overlapping strategies simultaneously with ongoing assessment of recruitment rates. In our experience, and others direct mail-outs work best although rights to privacy must be respected.ISRCTN83409867 and ACTR12605000658617.It is widely acknowledged that falls and fractures among older population are a major health problem and are associated with significant morbidity and reduced quality of life in Australia [1-4] and in other developed populations [5,6]. The highest rate of fracture and the highest number of fractures occur in the oldest sector (70 years and over) of the f %U http://www.biomedcentral.com/1471-2288/9/78