|
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.
|
