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Table 107. Adverse events reported in RCTs

Author Year

N enrolled

Vit D dose (IU/d)

Ca dose (mg/d)

Duration

Adverse Event data (n=case#)

Yamamoto 1995117

471

0

1000

6 mo

Comparing 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 2006215

112

300 D3

600 or 1200

12 mo

Bloating, constipation and intestinal discomfort apparently related to the calcium supplement

Bunout 200680

96

400

800

9 mo

Adverse 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 200671

36282

400

1000

7 y

The WHI trial found an increase in the risk of renal stones (Hazard Ratio 1.17 95% CI 1.02, 1.34), corresponding to 5.7 events per 10,000 person years of exposure.

Burleigh 200781

205

800 D3

1200

Median 1 mo

Hypercalcemia (n=2)

Lappe 2008208

5201

800

200

8 wks

GI disruption such as constipation, diarrhea, upset stomach (4%), and musculoskeletal soreness (0.9%)

Brooke 198034

126

1000

0

3rd trimester only

Vit D group (craniotabes, n=2), placebo group (hypocalcemia, n=5; craniotabes, n=6)

Lappe 200752

1180

1000 D3

1400-1500

4 y

Renal calculi in placebo (n=1), renal calculi in calcium only (n=3), renal calculi in calcium plus vit D (n=1)

Mastaglia 2006240

65

5000 or 10,000 D2

500

3 mo

Hypercalciuria (n=1) in control group

Zhu 200898

256

1000 D2

1200

12 mo

There 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 200850

445

Group 1: 2 capsules of vitamin D3 each 20,000 IU taken twice a week (Monday and Thursday): ~5714 IU/d

Group 2: 1 capsules of vitamin D3 each 20,000 IU taken twice a week (Monday and Thursday): ~2857 IU/d

500

12 mo

Primary 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.



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