Effects of Nutritional Iron Absorption Enhancers and Inhibitors and Daytime on Absorption From Oral Iron Supplements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Fractional iron absorption [percent]
研究概览
简要总结
Iron deficiency (ID) is a major public health problem worldwide and oral iron supplementation can be an effective strategy to treat and prevent ID. To maximize iron bioavailability form oral iron supplements the simultaneous intake of the iron absorption enhancer ascorbic acid (AA) is recommended, and the simultaneous intake of coffee or tea containing the iron absorption inhibitors polyphenols should be avoided. Also, oral iron supplements are recommended to be taken on an empty stomach in the morning and without a meal to avoid any interaction with phytic acid, another iron absorption inhibitor present in many foods. However, the effects of these iron absorption enhancers and inhibitors have only been shown on iron absorption from dietary iron (up to 10mg). Also, the effect of the diurnal hepcidin increase on absorption from an iron supplement given in the afternoon without a preceding morning dose is unclear. Whether AA also increases iron bioavailability from a supplemental iron dose and whether a cup of coffee, a breakfast or iron administration in the afternoon decreases iron bioavailability from a supplemental dose is uncertain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, 18 to 45 years old,
- •SF levels <30 μg/L,
- •Body weight < 70 kg
- •Normal Body Mass Index (18.5-25 kg/m2),
- •Signed informed consent.
排除标准
- •Anemia (Hb < 12 g/dL)
- •Elevated CRP > 5 mg/L,
- •Any metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement) affecting iron metabolism,
- •Continuous/long-term use of medication during the whole study, which may interfere with iron absorption, gut physiology and iron metabolism,
- •Consumption of mineral and vitamin supplements since screening and over the study period until last blood sample collection,
- •Difficulties with blood sampling,
- •Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 6 months,
- •Known hypersensitivity or allergy to iron capsules in the given amount (ferrous fumarate, brilliant blue FCF (E133), titandioxide (E171) and sodium lauryl sulfate)
- •Pregnancy, breastfeeding
- •Women who intend to become pregnant during the course of the study,
- •Known or suspected non-compliance, drug or alcohol (more than 2 drinks/day) abuse,
- •Smokers (> 1 cigarette per week),
- •Participant is likely to be absent on one the study appointments,
- •Inability to follow the procedures of the study, e.g. due to language problems, self-reported psychological disorders, etc. of the participant.
结局指标
主要结局
Fractional iron absorption [percent]
时间窗: Day 43
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
Total iron absorption [mg]
时间窗: Day 43
Total iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products. Total iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
次要结局
- Hemoglobin (Hb)(Day 1, 22, 26 and 43)
- Alpha-1-acid-glycoprotein (AGP)(Day 1, 22, 26 and 43)
- Hepcidin(Day 1, 22 and 26)
- Serum ferritin (SF)(Day 1, 22, 26 and 43)
- Serum transferrin receptor (sTfR)(Day 1, 22, 26 and 43)
- Serum iron (SFe)(Day 1, 22, 26 and 43)
- Total iron binding capacity (TIBC)(Day 1, 22, 26 and 43)
- C-reactive protein (CRP)(Day 1, 22, 26 and 43)