Effects of vitamin D and calcium on bone and falls in an elderly population of Australian women selected for their history of falling

A randomised controlled study to evaluate the effects of vitamin D and calcium on lowering fall risk and improving bone structure in an elderly population of Australian women with low vitamin D status and a history of falling

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000331538

Enrollment

294

Registered

2006-08-03

Start date

2003-04-01

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

This is a one-year randomised, double blind, placebo controlled study designed to evaluate the effects of ergocalciferol and calcium supplementation compared to calcium alone on fall risk and bone structure in elderly women with a plasma 25-hydroxy vitamin D level below 60 nmol/L and a history of falling in the past 12 months. Subjects were randomised by personnel having no contact with study subjects. The study subjects and the study staff remained blinded to the treatment codes during the 1 year study.

Interventions

A one-year randomised double-blind clinical trial of oral supplementation of 1000 International Units of ergocalciferol per day versus placebo. All subjects received 1000 mg of calcium per day orally as calcium citrate.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

70 Years to 90 Years

Healthy volunteers

Inclusion criteria

A history of falling in the past 12 months; plasma 25-hydroxy vitamin D concentration less than 60 nmol/L.

Exclusion criteria

Fracture in the past 6 months; receiving bone active agents including vitamin D; a mini mental state score less than 24; bone mineral density Z score of less than -2.0; medical conditions or disorders that influence bone mineral metabolism or substantially impair balance; significant illness; laboratory evidence of renal insufficiency (creatinine more than twofold of the normal value).

Outcome results