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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.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000658617
Acronym
Vital D Study
Enrollment
2300
Registered
2005-10-19
Start date
2003-02-24
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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

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.

Sponsors

The University of Melbourne
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
70 Years to No maximum
Healthy volunteers
No

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 31, 2026