Supplemental vitamin D doses of 3200–4000 IU/d appear to increase the risk of hypercalcemia and some other adverse events in a small proportion of individuals, indicating that this dose is not completely safe. Quality assessment revealed high risk of incomplete reporting of safety-related outcome data. Risks of hypercalciuria, kidney stones, and mortality did not differ significantly between study arms. Risks of falls and hospitalization were also significantly increased in the vitamin D arm with an RR of 1.25 (95%CI: 1.01–1.55 4 studies) and 1.16 (95%CI: 1.01–1.33 7 studies), respectively.
control arm was 2.21 (95%CI: 1.26–3.87 10 studies), with a vitamin D-induced frequency of hypercalcemia of 4 cases per 1000 individuals. The relative risk (RR) of hypercalcemia in the vitamin D vs. All trials used supplemental vitamin D 3.
The selected trials comprised a total number of 12,952 participants. Parameters of calcium metabolism, falls, hospitalization, and mortality were assessed. We performed a systematic review and meta-analysis of randomized controlled trials in several databases and identified 22 trials reporting safety data. We summarized reported harmful effects of a daily vitamin D supplement of 3200–4000 IU in trials lasting ≥ 6 months. The upper tolerable intake level for vitamin D in the general population has been set at 4000 international units (IU) daily, but considerable uncertainty remains.
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