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STAREE Study: Vitamin D in Older Adults
The STAREE trial investigated whether high-dose vitamin D3 supplementation could improve disability-free survival in older adults aged 60 and above.
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The STAREE trial investigated whether high-dose vitamin D3 supplementation could improve disability-free survival in older adults aged 60 and above.
What Is the STAREE Study?
The STAREE study (STudy of the cardiovascular, cancer, muscle and cognitive effects of vitamin D supplementation in the Elderly) is a large-scale, randomised, double-blind, placebo-controlled clinical trial conducted in Australia by Monash University in Melbourne. The study investigated whether long-term supplementation with high-dose vitamin D3 could improve health outcomes and reduce disability and dependency in adults aged 60 years and older.
Background and Objectives
Low vitamin D levels are common in older adults. Observational studies and laboratory research had suggested that vitamin D might protect against cardiovascular disease, cancer, cognitive decline, and muscle weakness. The STAREE trial aimed to rigorously test these associations in a large clinical setting.
The primary endpoint of the study was disability-free survival – defined as survival without persistent disability or dementia. Secondary endpoints included cardiovascular events, cancer incidence, falls, cognitive function, and muscle strength.
Study Design
- Study type: Randomised, double-blind, placebo-controlled trial
- Participants: More than 18,000 adults aged 60 years and older in Australia, without known cardiovascular disease or diabetes at baseline
- Intervention: Monthly oral dose of 60,000 IU of vitamin D3 (equivalent to approximately 2,000 IU per day) for an average of five years
- Comparison: Matching placebo
- Timeline: Recruitment began in 2015; primary results were published in 2023 in the New England Journal of Medicine
Key Findings
The primary results of the STAREE trial, published in the New England Journal of Medicine in 2023, demonstrated:
- High-dose vitamin D3 supplementation did not significantly improve disability-free survival in older adults compared to placebo.
- There was no significant difference in all-cause mortality between the vitamin D group and the placebo group.
- Secondary endpoints, including major cardiovascular events and cancer incidence, also showed no significant benefit from supplementation.
- A subgroup analysis suggested that participants with a body mass index (BMI) below 25 might derive some benefit from vitamin D supplementation – however, this finding requires further investigation.
Clinical Significance
The STAREE findings complement those of other major vitamin D trials, including the VITAL trial (USA) and the D-HEALTH trial (Australia). Taken together, current evidence suggests that routine high-dose vitamin D supplementation does not provide additional health benefits for older adults who already have adequate vitamin D levels.
For individuals with clinically confirmed vitamin D deficiency, medically supervised supplementation remains appropriate and recommended. The trial highlights the importance of evidence-based supplementation rather than broad population-wide recommendations without confirmed deficiency.
Conclusions for Patients
If you are aged 60 or older and are considering vitamin D supplementation, it is advisable to discuss this with your doctor. A blood test can determine whether an actual deficiency is present. Based on current evidence, routine high-dose vitamin D supplementation without a confirmed deficiency is not recommended for older adults in general.
References
- Zhu K et al. – Effect of Monthly High-Dose Vitamin D Supplementation on Disability-Free Survival in Older Adults: A Randomized Clinical Trial. New England Journal of Medicine, 2023. DOI: 10.1056/NEJMoa2300033
- Manson JE et al. – Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease. New England Journal of Medicine, 2019. DOI: 10.1056/NEJMoa1809944 (VITAL Trial)
- Monash University – STAREE Trial. Official study website: www.staree.org.au (accessed 2024)
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