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Vitamin D supplementation and adverse skeletal and non-skeletal outcomes in individuals at increased cardiovascular risk: results from the The International Polycap Study (TIPS)-3 randomized controlled trial

Published:November 14, 2022DOI:https://doi.org/10.1016/j.numecd.2022.11.001
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      Highlights

      • Monthly, high-dose vitamin D was compared to placebo in a middle-aged population at increase cardiovascular risk primary from South Asia, South East Asia and South America.
      • Vitamin D was not associated with a lower risk of fracture.
      • Vitamin D was not associated with a lower risk of composite adverse cardiovascular events, cancers, fractures or falls.
      • A higher risk of death was observed in the Vitamin D group.
      • Results do not support the routine use of high-dose vitamin D in similar populations.

      Abstract

      Background and Aims

      Vitamin D has mostly been tested in Western populations. We examined the effect of high dose vitamin D in a population drawn predominantly from outside of Western countries.

      Methods and Results

      This randomized trial tested vitamin D 60,000 IU monthly in 5670 participants without vascular disease but at increased CV risk. The primary outcome was fracture. The secondary outcome was the composite of CV death, myocardial infarction stroke, cancer, fracture or fall. Death was a pre-specified outcome.
      Mean age was 63·9 years, and 3005 (53·0%) were female. 3034 (53·5%) participants resided in South Asia, 1904 (33·6%) in South East Asia, 480 (8·5%) in South America, and 252 (4·4%) in other regions. Mean follow-up was 4·6 years. A fracture occurred in 20 participants (0·2 per 100 person years) assigned to vitamin D, and 19 (0·1 per 100 person years) assigned to placebo (HR 1·06, 95% CI 0·57-1·99, p-value = 0·86). The secondary outcome occurred in 222 participants (1·8 per 100 person years) assigned to vitamin D, and 198 (1·6 per 100 person years) assigned to placebo (HR 1·13, 95% CI 0·93-1·37, p=0·22). 172 (1·3 per 100 person years) participants assigned to vitamin D died, compared with 135 (1·0 per 100 person years) assigned to placebo (HR 1·29, 95% CI 1·03-1·61, p=0·03).

      Conclusion

      In a population predominantly from South Asia, South East Asia and South America, high-dose vitamin D did not reduce adverse skeletal or non-skeletal outcomes. Higher mortality was observed in the vitamin D group.

      Registration number

      NCT01646437.
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