This randomized, placebo-controlled study examined the effect of vitamin D replacement therapy on neuropathic symptoms and balance in patients with diabetic neuropathic pain and low vitamin D levels.
Among the 258 patients, the results in a total of 57 volunteers (32 in the treatment and 25 in the control arm) meeting the inclusion criteria are reported. Symptoms of neuropathic pain were assessed using Douleur Neuropathique 4 (DN4) questionnaire, and presence of polyneuropathy (PNP) was determined by performing electromyography (EMG). Balance was assessed using Berg balance test (BBT). After undergoing these examinations, the patients in the treatment group were intramuscularly (IM) injected with 300,000 IU vitamin D in a liquid formulation and those in the placebo group were IM injected with physiological saline. The DN4 and BBT were repeated after 12 weeks, and the results were compared.
The patients in the treatment group showed a significant decrease in total DN4 scores from baseline to the study endpoint compared with the patients in the placebo group (p=0.008). The patients in the treatment group also showed a significant increase in BBT scores from baseline to the study endpoint compared with the patients in the placebo group (p=0.001). Furthermore, in subgroup analysis, these patients showed a significant decrease in electric shock and burning sensation scores from baseline to the study endpoint compared with the patients in the placebo group (p=0.006, p=0.001, respectively).