Vitamin D Intervention To Prevent Falls and Fractures and To Promote Mental Well-Being.
Primary Care Prevention of Falls and Fractures in the Elderly by Annual Vitamin D Supplementation.
The University of Melbourne
2,300 participants
Feb 24, 2003
Interventional
Conditions
Summary
The study hypothesis is that an annual high dose (500,000 IU) of vitamin D2 will reduce the rate of falls and fracture compared with placebo in older women.
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Interventions
A Double-Blind Randomised Placebo-Controlled Vitamin D InterventionTrial in which 2,300 women at high risk of fracture are randomised to receive treatment (500,000 IU ergocalciferol orally) or placebo every Autumn/Winter for three to five consecutive years. Participants are asked to complete a diary to record any falls and fractures. This information is collected monthly and confirmed. Participants also complete a validated mental well-being questionnaire at several timepoints throughout the study A subset of 126 women randomly selected undergo more intensive testing throughout the project. At regular intervals these women undergo basic clinical anthropometry, balance and muscle strength assessment; questionnaires to assess mental well-being and pathology testing.
Locations(1)
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ACTRN12605000658617