Effect of four monthly oral vitamin D₃ (cholecalciferol) supplementation on fractures and mortality in men and women living in the community: randomised double blind controlled trial

From the mid 1980s, North Manchester podiatry service offered all its
patients over the age of 65, 100,000 i.u. vitamin D orally twice yearly
when they were seen for their podiatry needs. This was based on the
suggestive evidence that vitamin D deficiency increased the risk of hip
fracture and caused osteomalacia. As there had been no intervention trial
of vitamin D for the reduction of osteomalacia, we undertook such a study
in Bolton in 1996-8 (1)

The prevalence of osteomalacia in the elderly has been estimated at
rates of 1.5% to 4%(2-4). In this double-blind study, 3,443 patients aged
over 65 were randomised to either 5ml of arachis oil containing 30,000
i.u. of vitamin D or 5ml of arachis oil only.

In the absence of any validated questionnaire for osteomalacia,
patients were asked about non-joint pain by a series of questions
(available on request) at two to three months and, for who had an
improvement in bone pain at this first assessment, at twelve months after
further doses of vitamin D or placebo every two to three months.

Of the 3,443 patients who took part in the study, 1,246 (36%)
reported non-joint bone pain at baseline. The results showed no
difference between the two groups (full results available on request). For
example, amongst those initially reporting non-joint bone pain, the
results at three months were:

Number 	    Number       Total	             improved(%)    worse(%)  
number
Intervention	     113 (17.5)	    20 (3.1)	 645
Control	             105 (17.5)	    21 (3.5)	 601

Although we failed to show any difference or get our results
published, mainly due to the use of unvalidated questions, both this study
and the experience in North Manchester shows the feasibility of
podiatrists administering vitamin D in their everyday work. As it appears
that vitamin D does reduce fractures(5), and podiatrists see a
considerable proportion of people aged over 65, their possible role should
be considerd.

Competing interests:  
None declared