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.