The effectiveness of vitamin D 2000 IU as add-on therapy for painful diabetic neuropathy patients: randomized controlled trial

Abstract Background Painful diabetic neuropathy is a major burden of health problems worldwide and a major microvascular complication in patients with diabetes mellitus. Patients with painful diabetic neuropathic (PDN) have a poor quality of life as a result of disturbed sleep and daily activities. Previous epidemiological data have shown that vitamin D deficiency is common and closely related to the severity of diabetic neuropathy. Available symptomatic therapy does not significantly reduce pain. Clinical trials of the benefits of supplemental vitamin D therapy are still limited and have not been widely conducted in Indonesia. To measure the effectiveness of 2000 IU of vitamin D as adjunctive therapy for painful diabetic neuropathy patients. Methods This study was a randomized controlled trial, comparing a control group receiving symptomatic therapy and an experimental group receiving symptomatic therapy and 1000 IU twice daily vitamin D for 8 weeks. Sampling was conducted using a consecutive sampling technique. Data analysis was performed univariate and bivariate with the Mann–Whitney test. The outcome of the study was the Brief Pain Inventory (BPI). Results Data were obtained from 60 patients divided into two groups with similar baseline characteristics. From the results of the Mann–Whitney test, it was found that giving 1000 IU of vitamin D twice a day could reduce pain and improve sleep quality ( p = 0.004), daily activities ( p = 0.003), and mood ( p = 0.002) in the experimental group compared to the control group. Conclusions Giving vitamin D 2000 IU as add-on therapy for painful diabetic neuropathic patients effectively reduces pain and improves sleep quality, daily activity abilities, and patient's mood. Trial registration INA REGISTRY, INA-WHMG3FX. Registered 3 February 2020, https://ina-registry.org/?act=registry_trial_detail&code_trial=08202048022521WHMG3FX .