The D-Health Trial: A trial of vitamin D for prevention of mortality and cancer in older Australian adults.

Phase 3

Active, not recruiting

• Conditions: Alternative and Complementary Medicine - Other alternative and complementary medicine; Mortality; Cancer; Public Health - Other public health; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12613000743763
• Lead Sponsor: QIMR Berghofer Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-04
• Last Update Posted: 27 September 2021

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 21315

Inclusion Criteria

1. Aged 60 to 79 years old
2. Enrolled to vote
3. Do not have any of the health conditions listed in exclusions criteria and are not cognitively impaired
4. Are not taking vitamin D at doses greater than 500 IU/day

Exclusion Criteria

People will be excluded if they are unable to give consent or to communicate well enough in English to understand study materials or if they indicate in an initial screening form that they:
1. Have any of the following medical conditions (which either preclude or require high dose vitamin D supplementation or prevent informed consent): hyperparathyroidism, sarcoidosis, osteomalacia, osteoporosis, a history of renal calculi, a history of high calcium
2. Are taking vitamin D at doses greater than 500 IU/day
3. Cognitive impairment
4. Do not have a telephone (landline or mobile)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome: All cause mortality as assessed though data linkage to the National Death Index (NDI).[Time point: Linkage to the NDI for up to 15 years]

Secondary Outcome Measures

Name	Time	Method
Secondary outcome: Total cancer incidence, colorectal cancer incidence. <br>Assess though linkage to Australian Cancer Registers.<br>[Time point: Linkage to Cancer Registers for up to 15 years<br>];Tertiary Outcome: Total cardiovascular events, depression, upper respiratory illnesses, exacerbations of asthma or chronic obstructive pulmonary disease, hyper- or hypothyroidism, diabetes, high blood pressure, falls, fractures, arthritis, use of anti-inflammatory, use of antibiotics, cognitive decline, overall self-reported health status, muscle aches and pains. <br>Assess though D-Health Annual Surveys and Data linkage to health records.<br>[Time point: Baseline and annual surveys for 5 years and linkage to health records for up to 15 years]