TABLE 5.
Reported safety outcomes1
| Group | Safety outcome | Ratio of new to total RCTs2 | Quality of new RCTs (quality score: no. of RCTs)3 |
| Infants (adapted from reference 13, Table 18, p 191) | Hypercalcemia, hypercalciuria | 1:2 | ≤2 (1 RCT) |
| Children (adapted from reference 13, Table 18, p 192) | Hypercalcemia, hypercalciuria, withdrawal because of adverse effects | 1:1 | ≥3 (1 RCT) |
| Women predominantly of productive age ± middle-aged men (adapted from reference 13, Table 18, pp 192–193) | Hypercalcemia, hypercalciuria | 2:2 | ≤2 (2 RCTs) |
| Predominantly postmenopausal women and/or elderly men (adapted from reference 13, Table 18, pp 193–204) | Serum calcium, hypercalcemia, hypercalciuria, kidney stones, mortality, gastrointestinal, ratio of urinary calcium to creatinine, 24-h urinary calcium, creatinine clearance, serum uric acid, high level of adverse effects, withdrawal because of adverse effects, osteomuscular effects, mortality, serum creatinine, total adverse events, renal insufficiency | 11:17 | ≤2 (2 RCTs) |
| ≥3 (9 RCTs) |
Data adapted from Cranney et al, 2007 (13). RCT, randomized clinical trial.
“New” refers to references not likely to have been available to the 1997 Dietary Reference Intake Committee and included all studies published after 1997 and studies published during 1997 that were not cited in the master reference list for the 1997 Institute of Medicine's report “Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride” (3) and excluded studies published before and during 1996 and studies published during 1997 that were cited in the master reference list for the 1997 Institute of Medicine's report.
The study quality was assessed in the systematic review (13) by using the validated Jadad scale with a score of ≥3 (out of a possible 5) indicating studies of higher quality.