Table 107Adverse events reported in RCTs

Author YearN enrolledVit D dose (IU/d)Ca dose (mg/d)DurationAdverse Event data (n=case#)
Yamamoto 1995 117471010006 moComparing calcium group to the placebo group, excessive gas and bloating were more frequently reported by white women at 3 months and by whites, in general, at 6 months, and white men reported more loose stools at 6 months.
Moschonis 2006 215112300 D3600 or 120012 moBloating, constipation and intestinal discomfort apparently related to the calcium supplement
Bunout 2006 80964008009 moAdverse events that required hospital admission:
Vit D plus exercise training group (n=3): retrosternal pain, a non-ST elevation myocardial infarction and a transient ischemic attack.
 Calcium, Vit D plus exercise training group (n=1): acute cholecystitis
Wactawski-Wende 2006 713628240010007 yThe WHI trial found an increase in the risk of renal stones (Hazard Ratio1.17 95% CI 1.02, 1.34), corresponding to 5.7 events per 10,000 person years of exposure.
Burleigh 2007 81205800 D31200Median 1 moHypercalcemia (n=2)
Lappe 2008 20852018002008 wksGI disruption such as constipation, diarrhea, upset stomach (4%), and musculoskeletal soreness (0.9%)
Brooke 1980 34126100003rd trimester onlyVit D group (craniotabes, n=2), placebo group (hypocalcemia, n=5; craniotabes, n=6)
Lappe 2007 5211801000 D31400–15004 yRenal calculi in placebo (n=1), renal calculi in calcium only (n=3), renal calculi in calcium plus vit D (n=1)
Mastaglia 2006 240655000 or 10,000 D25003 moHypercalciuria (n=1) in control group
Zhu2008982561000 D2120012 moThere were no significant differences between the vitamin D and the control groups in the rate of incident cancer and vascular disease (ischemic heart disease and stroke).
There were 8 and 5 adverse events in vitamin D and the control groups, respectively. One participant in the vitamin D group had mild asymptomatic hypercalcemia one occasion. No case of renal calculus was reported.
1 participant was deceased during the study.
Sneve 200850445Group 1: 2 capsules of vitamin D3 each, 20000 IU taken twice a week (Monday and Thursday): ~5714 IU/d
Group 2: 1 capsules of vitamin D3 each20,000 IU taken twice a week (Monday and Thursday): ~2857 IU/d
50012 moPrimary hyperparathyroidism (n=2), increase in serum calcium to 2.62 mmol/L (n=1), transient increases in serum calcium > 2.59 mmol/L (n=4).

317 other adverse events were recorded, most of them related to GI discomfort. There were no significant differences between the treatment groups regarding adverse events.

From: 3, Results

Cover of Vitamin D and Calcium
Vitamin D and Calcium: A Systematic Review of Health Outcomes.
Evidence Reports/Technology Assessments, No. 183.
Chung M, Balk EM, Brendel M, et al.

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