<b>VITAFOOT: A double-blind, randomized controlled pilot trial of combined Vitamin C, Vitamin A and zinc supplementation in people with non-healing diabetes-related foot ulcers</b>

<p dir="ltr"><b>Objective:</b> Micronutrient deficiencies are common in patients with diabetes-related foot ulcers (DFU), however effects of micronutrient supplementation on DFU healing are unclear. We evaluated the effect of combined vitamin C (VitC), vitamin A (VitA) and zinc supplementation on wound healing in patients with non-healing DFU.</p><p><br></p><p dir="ltr"><b>Research Design and Methods:</b> Participants in this double-blinded, randomized controlled pilot trial were assigned to receive 28 days of combination supplement containing VitC (1000mg), VitA (750mcg/2500IU) and zinc picolinate (25mg) daily or identical placebo. The primary outcome was percentage change in DFU area from baseline to 12 weeks. Post-hoc exploratory outcomes included complete healing at 4 and 12 weeks.</p><p><br></p><p dir="ltr"><b>Results: </b>Ninety-nine participants were randomized to placebo (n=50) or intervention (n=49) groups. <a href="" target="_blank">Baseline deficiency in VitC, VitA and zinc was observed in 49 (49.5%), 1 (1%) and 11 (11.1%) participants, respectively</a>. At 12 weeks there was a median [interquartile range] 65% [10-100%] reduction in DFU area in intervention group and 75% [43-100%] reduction in DFU area in placebo group (<i>P</i>=0.42). At 4 weeks, 7/49 (14.3%) DFUs healed in intervention group compared with 1/50 (2%) in placebo group<i> (P</i>=0.02). At 12 weeks, 13/49 (26.5%) wounds were healed in intervention group, and 14/50 (28%) in placebo group (<i>P</i>=0.87).</p><p><br></p><p dir="ltr"><b>Conclusions:</b> Despite high baseline rates of VitC deficiency, <a href="" target="_blank">micronutrient supplementation for 28 days did not improve percentage change in DFU area at 12 weeks. A higher proportion of patients had complete DFU healing at 4 weeks in the intervention group, but no difference at 12 weeks compared to standard care.</a></p><p dir="ltr"><b>Article Highlights:</b></p><p dir="ltr">· Why did we undertake this study?</p><p dir="ltr">-Diabetes related foot ulcers (DFU) take months to heal.</p><p dir="ltr">-Micronutrient deficiencies are common amongst people with DFU.</p><p dir="ltr">-Evidence that micronutrient supplementation improves DFU healing is limited</p><p dir="ltr">· What is the specific question we wanted to answer?</p><p dir="ltr">-Does combined micronutrient (VitC, VitA and zinc) supplementation improve DFU healing compared to standard care?</p><p dir="ltr">· What did we find?</p><p dir="ltr">-Vitamin C deficiency was common amongst people with DFU (49.5%).</p><p dir="ltr">-Combined micronutrient (VitC, VitA and zinc) supplementation for 28 days did not improve percentage change in DFU area at 12 weeks.</p><p dir="ltr">-There was a higher proportion of patients with complete DFU healing at 4 weeks in the intervention group</p><p dir="ltr">· What are the implications of our findings?</p><p dir="ltr">Micronutrient supplementation was not associated with improved DFU healing at 12 weeks.</p>