Comparing Oral Iron Supplementation Using Alternate-day Dosing to the Standard of Care Consecutive-day Dosing in Iron-depleted Women With or Without Mild Anemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Serum Ferritin (SF)
研究概览
简要总结
Iron deficiency (ID) with or without anemia is a major public health problem worldwide, especially in women of reproductive age. Iron supplementation can be an effective strategy to prevent and treat ID and iron deficiency anemia (IDA). Recent studies suggests that giving oral iron every other day would be an optimized dosing regimen with maximized absorption and a lower incidence of gastrointestinal side effects compared to consecutive day dosing. Long-term trials in which participants and investigators are blinded to the dosing interval with iron status and gastrointestinal side effects as study outcomes are needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double-blinded randomized controlled study: participants and investigators are blinded
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 <25 μg/L,
- •Hb levels ≥ 11 g/dL
- •Normal Body Mass Index (18.5-25 kg/m2),
- •In possession of a mobile phone on which the study app can be loaded,
- •Signed informed consent,
- •Not mandatory (only for subgroup analysis): having participated in a former stable iron isotope study in our laboratory between 1-5 y ago
排除标准
- •Elevated CRP > 5 mg/L,
- •Any metabolic, gastrointestinal, kidney or chronic disease (self-reported) affecting iron metabolism,
- •Continuous/long-term use of medication, which may interfere with iron absorption, gut physiology and iron metabolism,
- •Consumption of additional iron supplements over the study period,
- •Consumption of iron supplements since screening,
- •Difficulties with blood sampling,
- •Known hypersensitivity or allergy to iron or placebo capsules in the given amount (ferrous sulfate, mannitol, silica)
- •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.
研究组 & 干预措施
Consecutive Day Dosing
100 mg iron as FeSO4 daily for 3 months, followed by matched placebo daily for 3 months.
干预措施: Consecutive Day Dosing (Dietary Supplement)
Alternate Day Dosing
100 mg iron as FeSO4 and matched placebo on alternating days for 6 months.
干预措施: Alternate Day Dosing (Dietary Supplement)
结局指标
主要结局
Serum Ferritin (SF)
时间窗: Day 186
in alternate day group
Event rate of GI side effects
时间窗: Day 183
in alternate day group
Serum Ferritin (SF)
时间窗: Day 93
in consecutive day group
Event rate of GI side effects
时间窗: Day 90
in consecutive day group
次要结局
- Total iron binding capacity (TIBC)(Day 186)
- Serum Iron (SFe)(Day 186)
- Hemoglobin (Hb)(Day 183)
- Serum Ferritin (SF)(Day 186)
- Serum Transferrin Receptor (sTfR)(Day 186)
- Calprotectin(Day 183)
- Event rate of GI side effects(Day 183)
- Event proportion of GI side effects(Day 183)
- Iron absorption from supplements(Day 183)
- C-Reactive Protein (CRP)(Day 186)
- Alpha-1-acid Glycoprotein (AGP)(Day 186)
- Intestinal Fatty Acid-binding Protein (I-FABP)(Day 183)
- Hepcidin(Day 183)
- Incidence of GI side effects(Day 183)
- Severity of GI side effects(Day 183)
- Fecal blood losses(Day 183)
- Serum Iron (SFe)(Day 0)
- Serum Iron (SFe)(Day 93)
- C-Reactive Protein (CRP)(Day 0)
- C-Reactive Protein (CRP)(Day 46)
- C-Reactive Protein (CRP)(Day 93)
- C-Reactive Protein (CRP)(Day 139)
- Alpha-1-acid Glycoprotein (AGP)(Day 0)
- Alpha-1-acid Glycoprotein (AGP)(Day 46)
- Alpha-1-acid Glycoprotein (AGP)(Day 93)
- Alpha-1-acid Glycoprotein (AGP)(Day 139)
- Intestinal Fatty Acid-binding Protein (I-FABP)(Day 0)
- Intestinal Fatty Acid-binding Protein (I-FABP)(Day 90)
- Calprotectin(Day 0)
- Calprotectin(Day 90)
- Hepcidin(Day 0)
- Hepcidin(Day 46)
- Hepcidin(Day 90)
- Hepcidin(Day 139)
- Event rate of GI side effects(Day 90)
- Incidence of GI side effects(Day 90)
- Event proportion of GI side effects(Day 90)
- Severity of GI side effects(Day 90)
- Fecal blood losses(Day 0)
- Fecal blood losses(Day 90)
- Iron absorption from supplements(Day 90)
- Hemoglobin (Hb)(Day 90)
- Hemoglobin (Hb)(Day 139)
- Serum Ferritin (SF)(Day 0)
- Serum Ferritin (SF)(Day 46)
- Serum Ferritin (SF)(Day 93)
- Serum Ferritin (SF)(Day 139)
- Serum Transferrin Receptor (sTfR)(Day 0)
- Serum Transferrin Receptor (sTfR)(Day 46)
- Hemoglobin (Hb)(Day 0)
- Total iron binding capacity (TIBC)(Day 0)
- Total iron binding capacity (TIBC)(Day 93)
- Hemoglobin (Hb)(Day 46)
- Serum Transferrin Receptor (sTfR)(Day 93)
- Serum Transferrin Receptor (sTfR)(Day 139)
研究者
Jessica Rigutto
Dr.
Swiss Federal Institute of Technology