Iron Bioavailability From Salt Fortified With Ferrous Sulphate, Zinc Sulphate and Ascorbic Acid Encapsulated in a Polymer Jacket
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline in the isotopic ratio of iron in blood at week 2
研究概览
简要总结
Salt is one of the very few regularly purchased food item in all socioeconomic classes including poor remote areas with subsistence farming. Therefore, it is a promising vehicle for fortification with micronutrients, such as iodine, iron, vitamin A, to alleviate the burden of micronutrient deficiencies. However, ensuring the bioavailability of iron and the sensory quality in fortified salt is difficult. Water-soluble iron compounds, such as ferrous sulphate FeSO4, are the most bioavailable, but they react with moisture and impurities in salt, and cause unacceptable changes in colour. Encapsulation can reduce iron-mediated colour change in fortified salt without significantly compromise bioavailability. In the present project we aim to investigate the iron bioavailability from salt fortified with FeSO4 using a new encapsulation type based on hyaluronic acid (HA) and a polymer from the eudragit family (EPO).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, 18 to 40 years old
- •Marginal iron status (ferritin < 25 ng/ml)
- •Body weight < 65 kg
- •Normal body Mass Index (18.5 - 25 kg/m2)
- •Signed informed consent
排除标准
- •Pregnancy (assessed by a pregnancy test) / intention to become pregnant
- •Lactating up to 6 weeks before study initiation
- •Moderate or severe anaemia (hemoglobin < 9.0 g/dL)
- •Elevated C-reactive protein (> 5.0 mg/L)
- •Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
- •Continuous/long-term use of medication during the whole study (except for contraceptives)
- •Consumption of mineral and vitamin supplements within 2 weeks prior to 1st meal administration
- •Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
- •Earlier participation in a study using Fe stable isotopes or participation in any clinical study within the last 30 days
- •Participant who cannot be expected to comply with study protocol (e.g. not available on certain study appointments or difficulties with blood sampling)
结局指标
主要结局
Change from baseline in the isotopic ratio of iron in blood at week 2
时间窗: baseline, 2 weeks
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Change from week 2 in the isotopic ratio of iron in blood at week 4
时间窗: 2 weeks, 4 weeks
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
次要结局
未报告次要终点