A large-scale nationwide clinical study reports its findings. It showed that high-dose Vitamin D supplementation does not lower cancer or malignancy incidence (risk). In addition, supplementation does not help prevent prostate, endometrial, lung, breast, pancreatic, and other primary cancers. However, it did have a minor positive effect on non-obese individuals.
Vitamin D & Cancer Risk: vitamins D and omegA-3 trial (VITAL)
A prospective clinical study performed by researchers at the Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School showed the relation between Vitamin D and cancer. The National Institute of Health (NIH) funded this research. The main aim was to find if Vitamin D supplementation helps prevent cancer. The results of this prospective VITAL study (VITamin D and omegA-3 trial) (NCT01169259) are in the New England Journal of Medicine (Manson JE et al, New Engl J Med., 2019).
Key highlights of the trial design, scientific rationale, and results are below:
Trial Design for VITAL Study
- There was a total of 25,871 participants in this study, which included 50 year
- old men and 55 years and older women.
- The experimental participants consumed 2000 IU of Vitamin D3 (cholecalciferol) supplements per day (2-3 times the recommended dietary allowance). The placebo group had no Vitamin D supplementation.
- Enrolled participants had no history of cancer at trial entry.
- The primary endpoint was assessing the diagnosis of invasive cancer of any type. This would help researchers calculate the risk of breast cancer and other major cancers.
- The median follow-up of the participants was 5.3 years.
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Scientific Rationale for VITAL Study
- Vitamin D supplementation helped prevent breast, prostate, endometrial, lung, and other primary cancers. Additionally, Vitamin D supplementation and cardiovascular disease risk were also inversely proportional. It also helped prevent bone-related disorders in patients. However, the data from observational studies and meta-analysis showed a significant variation in results. Hence, this study explored vitamin D supplementation risks and benefits in a clinical setting.
- The use of Vitamin D supplementation has increased substantially in the US. (Kantor ED et al, JAMA, 2016)
- Observational studies have shown an association between increased sun exposure and body generated Vitamin D with lower cancer rates. (Mason JE et al, Contemp Clin Trials, 2012)
- Further observational studies showed an association between low serum levels of 25- hydroxy Vitamin D and increased risk of cancer. (Yin L et al, Prev. Med., 2013)
- VITAL study assessed Vitamin D supplementation risks and benefits. In addition, the study observed whether large doses of Vitamin D supplementation helped prevent cancer in adults with no prior history of cancer.
Results of VITamin D and omegA-3 trial.
- The randomized trial found no statistically significant difference in cancer diagnosis between the Vitamin D supplement and placebo groups. Vitamin D supplementation was not associated with a lower risk of cancer.
- There was no significant difference in Vitamin D supplementation and cardiovascular disease risk, the incidence of breast cancer, prostate cancer, or ovarian cancer.
- Vitamin D supplementation did not lead to a significantly lower incidence of invasive cancer compared to the placebo group.
- However, results were slightly different for non-obese participants with a normal body mass index. When these participants received Vitamin D supplementation, they had a lower cancer risk. This contradictory information exists because of hormonal dysregulation, which in obese individuals reduces the benefit of Vitamin D supplementation.
In summary, this large-scale, randomized trial study highlighted that high-dose Vitamin D supplementation does not generally result in a lower cancer incidence, except in non-obese people. However, Vitamin D supplementation helps prevent bone-related conditions, so a recommended dose of 400–800 IU/day or 10–20 micrograms is beneficial. Additionally, sun exposure and an improved diet can help replace supplementation.
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