Cochrane

# Supplementary material 16 to:
Interventions for preventing falls in older people living in the community

Gillespie LD , Robertson MC , Gillespie WJ , Sherrington C , Gates S , Clemson L , Lamb SE
https://doi.org/10.1002/14651858.CD007146.pub3

Cochrane disclaims all liability and responsibility arising from any reliance placed on this supplementary material which has been supplied by the author(s). The above associated publication’s Author Licence will apply in respect of any supplemental materials published. How to cite the supplementary material is defined in the Cochrane policy.

# Adverse effects possibly attributable to vitamin D or vitamin D analogues reported in included studies

Study ID | Hypercalcaemia | Renal disease | Gastrointestinal effects | Other
--- | --- | --- | --- | ---
Bischoff-Ferrari 2006 (reported in Dawson-Hughes 1999) | ND | Only side effects resulting in discontinuation of treatment. Calcium–vitamin D group: hypercalciuria 1/219 | Only side effects resulting in discontinuation of treatment. Placebo group: epigastric distress 2/216. Calcium–vitamin D group: constipation 3/219, epigastric distress 1/219 | Only side effects resulting in discontinuation of treatment. Placebo group: flank pain 1/216. Calcium–vitamin D group: sweating 1/219.
Bischoff-Ferrari 2010 | At 7 to 10 days mild hypercalcaemia was recorded in two 800 IU participants and one 2000 IU participant. At 6-month follow-up mild hypercalcaemia was recorded in one 800 IU participant, and in two 2000 IU participants. | “Creatinine clearance did not differ significantly between groups at baseline or at 7 to 10 days, or 6 and 12 months of follow-up. There was no report of nephrolithiasis throughout the trial period.” | ND | ND
Dhesi 2004 | — | — | — | —
Dukas 2004 | "During the 36 weeks of intervention, six cases (1 in the placebo group and 5 in the alfacalcidol group) of slight transient hypercalcemia (one measurement of serum calcium above normal with subsequent (1 week later) control measurement within normal ranges) were observed..." "The difference in the incidence of hypercalcaemia between study groups was not significant (P=0.0621)." | ND | ND | “Frequency of reported side effects was equally distributed between treatment groups (82 cases in placebo vs 75 cases in alfacalcidol, P = 0.850. The most common side effects were itching (placebo treatment group: 23 cases; alfacalcidol treatment group: 22 cases) and skin eruption (placebo treatment group: 11 cases; alfacalcidol treatment groups: 15 cases)."
Gallagher 2001 | Mild hypercalcaemia occurred in 6% of placebo participants and 12% of calcitriol participants | "At least one episode of hypercalciuria (400 mg or 10 mmol) occurred in 8% of the patients on placebo, 26% on calcitriol ...There were 58 cases of hypercalciuria occurring on calcitriol alone" | Gastrointestinal problems were reported in the calcitriol group (N = 20) and the placebo group (N = 22) | ND
Grant 2005 | 21 participants developed hypercalcaemia; there was no significant difference between groups | 7 participants developed renal insufficiency and 4 developed renal stones. No significant difference between groups. | 428/2617 (16.4%) allocated to calcium; 319/2675 (11.9%) not allocated to calcium. 363/2646 (13.7%) allocated to vitamin D3; 386/2643 (14.7%) not allocated to vitamin D3 | ND
Harwood 2004 | No cases occurred in either participant group | ND | ND | ND
Kärkkäinen 2010 | ND | ND | Adverse events in the intervention group (N = 1586) resulting in discontinuation of the intervention. Gastrointestinal symptoms (abdominal pain and heartburn) 64/1586, nausea 12/1586 | Adverse events in the intervention group (N = 1586) resulting in discontinuation of the intervention Skin reactions 9/1586, miscellaneous other adverse effects (not individually listed) 28/1586
Latham 2003 | — | — | — | —
Pfeifer 2000 | — | — | — | —
Pfeifer 2009 | — | — | — | —
Porthouse 2005 | — | — | — | —
Prince 2008 | One participant in the ergocalciferol group had mild asymptomatic hypercalcaemia on one occasion | ND | Constipation: ergocalciferol group 16/151 (10.6%) vs control group 18/151 (11.9%) | No difference in incidence of cancer, ischaemic heart disease, or stroke
Sanders 2010 | ND | ND | ND | “Serious adverse events (International Conference on Harmonization/WHO Good Clinical Practice definition including hospitalization or death) did not differ significantly. None of the serious adverse events were considered related to study medication.”
Smith 2007 | — | — | — | —
Trivedi 2003 | ND | ND | ND | The incidence of major health events did not differ significantly between groups.

— : adverse events not described in the study

ND: no incidence available for this adverse event