Limitations
Given the study’s retrospective nature, at times there was difficulty in locating information in the EHR, including accurate reports of active medication use during study periods or documentation of all falls that had occurred in the appropriate format. This was further complicated by the reliance on self-reporting of falls, which may potentiate an underestimation of total falls.
The largely homogenous study population may limit extrapolating these results. Additionally, although some diseases and medications with an inherent risk on fall risk were incorporated into the exclusion criteria, on analysis, other diseases and medications were identified that also may pose a similar risk. These include legal blindness and a history of below-the-knee amputation as well as long-term opioid therapy and intensive antihypertensive therapy with multiple agents. Furthermore, other potential risk factors for falls were not addressed, such as functional status, use of assistive devices, or unsafe home environments.
For the secondary endpoint, sample size was not met for statistical significance, which limited the study’s ability to confirm the veracity of the trend of increased falls. Study duration posed an additional limitation. As most veterans enrolled in HBPC have vitamin D supplementation initiated soon after enrollment when the need for vitamin D repletion is routinely assessed, a 2-month duration for evaluation prior to and immediately following initiation of ergocalciferol was necessary to allow for adequate study enrollment for analysis of the primary endpoint. However, this may be resolved through conduction of a prospective study in the future.
Conclusion
There was no difference identified in the rate of falls immediately prior to and following initiation of ergocalciferol 50,000 IU self-administered once weekly. There was a trend of increased rate of falls in subjects with high levels of 25(OH)D achieved. In light of a similar finding of high-dose vitamin D3 associated with an increased rate of falls, particularly with higher achieved levels of 25(OH)D, it may be warranted to consider avoiding high-dose vitamin D2 supplementation. Future research including prospective, randomized clinical studies with a longer duration of follow-up would be recommended to confirm these findings and test the generalizability in the non-HBPC community-dwelling population.