Bries Amanda E, Wang Chong, Agbemafle Isaac, Wels Brian, Reddy Manju B
Department of Food Sciences and Human Nutrition, Iowa State University, Ames, IA, USA.
Department of Statistics, Iowa State University, Ames, IA, USA.
Curr Dev Nutr. 2019 Nov 7;3(12):nzz127. doi: 10.1093/cdn/nzz127. eCollection 2019 Dec.
Iron deficiency anemia (IDA) is a widespread nutritional deficiency, and iron supplementation, especially with ferrous sulfate (FeSO), is the most common strategy to treat IDA; however, compliance is often poor with daily FeSO owing to negative side effects. In a previous study, iron from iron-enriched [Ultimine Koji Iron (ULT)] was absorbed similarly to FeSO.
The main objective of this study was to assess the safety of consuming ULT in terms of increasing non-transferrin-bound iron (NTBI) and gastrointestinal distress.
Young female participants ( = 16) with serum ferritin <40 μg/L were randomly assigned to a double-blind, 9-wk crossover study with a 3-wk placebo/washout period between treatments. Oral FeSO and ULT supplements containing 65 mg Fe were administered daily for 21 consecutive days. On day 1, serum iron (SI), percentage transferrin saturation (%TS), and NTBI were measured for 8 h on the first day of iron consumption. Changes in biochemical indicators were evaluated after 3 wk consumption. Side effects questionnaires were completed weekly on 2 randomly selected weekdays and 1 weekend day for the entire study.
SI, %TS, and NTBI were all markedly higher during hours 2-8 (< 0.001) with FeSO than with ULT. Oxidative stress, inflammatory, and kidney and liver function markers remained unchanged with both supplementations compared with placebo. Changes in iron status markers were not significantly different among the 3 treatments. Individual or global side effects were not significantly different among all treatments. Even when common side effects of nausea, constipation, and diarrhea were combined, FeSO treatment had a significantly higher effect than ULT ( = 0.04) and placebo ( = 0.004) only at week 3, but the difference was not significant between ULT and placebo.
Low NTBI production and fewer common gastrointestinal side effects with ULT suggest that it is a safe oral iron supplement to treat IDA. This trial was registered at clinicaltrials.gov as NCT04018300.
缺铁性贫血（IDA）是一种普遍存在的营养缺乏症，补充铁剂，尤其是硫酸亚铁（FeSO），是治疗IDA最常见的策略；然而，由于副作用，每日服用FeSO的依从性往往较差。在之前的一项研究中，富含铁的[Ultimine Koji Iron（ULT）]中的铁与FeSO的吸收情况相似。
本研究的主要目的是评估服用ULT在增加非转铁蛋白结合铁（NTBI）和胃肠道不适方面的安全性。
血清铁蛋白<40μg/L的年轻女性参与者（n = 16）被随机分配到一项双盲、为期9周的交叉研究中，治疗期间有3周的安慰剂/洗脱期。每天连续21天口服含65mg铁的FeSO和ULT补充剂。在第1天，在开始服用铁剂的第一天测量血清铁（SI）、转铁蛋白饱和度百分比（%TS）和NTBI，持续8小时。服用3周后评估生化指标的变化。在整个研究过程中，每周在2个随机选择的工作日和1个周末填写副作用问卷。
在服用FeSO的2 - 8小时内，SI、%TS和NTBI均显著高于服用ULT的情况（P<0.001）。与安慰剂相比，两种补充剂在氧化应激、炎症以及肾脏和肝脏功能指标方面均无变化。三种治疗方法在铁状态指标的变化上没有显著差异。所有治疗方法在个体或总体副作用方面没有显著差异。即使将恶心、便秘和腹泻等常见副作用合并起来，仅在第3周时，FeSO治疗的副作用发生率显著高于ULT（P = 0.04）和安慰剂（P = 0.004），但ULT和安慰剂之间的差异不显著。
ULT产生的NTBI较低，常见胃肠道副作用较少，表明它是一种治疗IDA的安全口服铁补充剂。该试验已在clinicaltrials.gov上注册，注册号为NCT04018300。
