The impact of ready-to-use-therapeutic-food (RUTF) on micronutrient levels in undernourished children with cancer: a randomized open-labelled controlled study.
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BACKGROUND: Emerging evidence suggests that micronutrient deficiencies are predictive of poorer outcomes in children with cancer. We assessed the prevalence and clinical impact of circulating micronutrient concentrations, as well as the change in micronutrient status after RUTF supplementation, in undernourished children with cancer. METHODS: Undernourished children with cancer were randomized 1:1 to receive either standard nutritional therapy(SNT) or SNT + RUTF for 6 weeks. The primary outcome was weight gain, and secondary outcomes included changes in micronutrient status from study entry to 6 weeks, including serum copper, phosphorus, zinc, iron, B12 and 25-OH vitamin D3. Predefined laboratory reference cut-offs for low circulating micronutrient concentrations were applied. Clinical outcomes assessed were significant infection, grade 3-4 mucositis and treatment delay >1 week. RESULTS: Between July-2015 and March-2018, 260 subjects were enrolled; 191 (76.7%) had low circulating concentrations of at least one micronutrient and 37 (14.9%) low circulating concentrations of 3 or more micronutrients. Low circulating concentrations were noted with vitamin D3-111 (42.7%), serum zinc in 97 (37.3%), phosphorus-62 (23.8%) and iron-45 (18%). Fewer children who received RUTF-34 (27.6%) had low zinc concentrations compared to SNT-45 (35.7%, p = 0.045) and 35 (25.5%) had improvement in vitamin B12 concentrations compared to SNT-23 (18.3%, p = 0.045). Irrespective of treatment arm, low circulating zinc and copper at study entry were associated with treatment delay (OR 1.8; 95% CI 1.1-3.2 and OR 4.7; 95% CI 0.4-53.2, respectively). Low circulating vitamin B12 was associated with toxic death (OR 9.7; 95% CI 2.4-38.8). CONCLUSIONS: There is a high prevalence of low circulating micronutrient concentrations, specifically vitamin D3, zinc, phosphorus and iron in children with cancer, often associated with adverse clinical outcomes. Supplementation with RUTF showed an inconsistent improvement in micronutrient levels. The clinical impact of micronutrient deficiencies in children with cancer should be the focus of future interventional trials. There is a need for evidence-based micronutrient supplementation in children with cancer.