| Study characteristics |
| Methods |
RCT |
| Participants |
Setting: United Kingdom
N = 139
Sample: patients attending a falls clinic (78% women)
Age (years): mean 76.8 (SD 6.2)
Inclusion criteria: aged ≥ 65; community‐dwelling; fallen in previous 8 wks; normal bone chemistry; 25 OHD ≤ 12 µg/litre
Exclusion criteria: AMT < 7/10; taking vitamin D or calcium supplements; history of chronic renal failure, alcohol abuse, conditions or medications likely to impair postural stability or vitamin D metabolism |
| Interventions |
1. One intramuscular injection (2 ml) of 600,000 IU ergocalciferol
2. Control: one placebo injection of 2 ml normal saline |
| Outcomes |
1. Rate of falls
2. Number of people falling |
| Duration of the study |
6 months |
| Notes |
Flowchart in Figure 1 shows N = 139 randomised with 70 in intervention group, but Table 1 (baseline characteristics) shows N = 138 randomised with 69 in intervention group |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomised in blocks of 20, by computer program |
| Allocation concealment (selection bias) |
Low risk |
Randomised independently of the investigators |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Double‐blind, placebo‐controlled study |
| Blinding of outcome assessment (detection bias)
Falls and fallers |
Low risk |
All participants used a 6‐month falls diary which was reviewed with the patient by blinded trialist |
| Incomplete outcome data (attrition bias)
Falls |
Low risk |
SeeAppendix 3 for method of assessment |
| Incomplete outcome data (attrition bias)
Fallers |
Low risk |
SeeAppendix 3 for method of assessment |
| Risk of bias in recall of falls |
Low risk |
Falls recorded in falls diary which was reviewed at follow‐up assessment |
