The Effect of Vitamin D Supplementation on The Outcome of Treatment with Bevacizumab in Diabetic Macular Edema: A Randomized Clinical Trial
Abstract Purpose: Concomitant vitamin D deficiency (VDD) is speculated to aggravate diabetic macular edema (DME). We aimed to determine the effect of hypovitaminosis D correction on the outcome of treatment with intravitreal bevacizumab (IVB) in DME eyes.Methods: 83 eyes of 83 patients with DME were recruited and divided into three groups: normal vitamin D levels + IVB administration (Group 1 ), vitamin D insufficient/deficient + IVB administration (Group 2), and vitamin D insufficient/deficient + IVB administration+ oral vitamin D supplementation (Group 3). Visual (corrected distance visual acuity, CDVA) and anatomical (central macular thickness, CMT) outcomes of intervention were evaluated 1, 3, and 6 months after the triple IVB injections were completed. Serum vitamin D levels were measured 1 and 6 months after the third IVB administration. Results: In months 1, 3, and 6, after the basic triple IVB injection, visual acuity and CMT improved in all three groups, but improvements (both functional and anatomical) in groups 1 and 3 (sufficient vitamin D and corrected hypovitaminosis D) in month 6 were more significant than in group 2 (uncorrected hypovitaminosis D) (p <0.001). The mean number of IVB injections during follow-up was 5.33 (range: 4-7), which did not differ between the groups.Conclusion: Correction of vitamin D deficiency in DME patients with type 2 diabetes and vitamin D deficiency, in addition to IVB injections, may play a role in improving CDVA and CMT. However, this beneficial effect seems to be delayed by several months.Trial registration: Iranian Registry of Clinical Trials (IRCT), IRCT20200407046978N1, registered on April 11, 2020, - retrospectively registered. https://en.irct.ir/trial/46999