NCT01135576已完成不适用
Iron Fortified Beverages and Application in Women Predisposed to Anemia
National Research Council, Spain0 个研究点目标入组 122 人开始时间: 2008年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 主要终点
- Serum Ferritin
研究概览
简要总结
- The objective of the study is to know if consumption of an iron fortified fruit juice containing micronized iron pyrophosphate, is useful to increase iron status in women predisposed to iron deficiency anemia.
- A secondary objective is to know if consumption of this iron fortified fruit juice modifies bone remodelling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •non-smoker
- •non-pregnant
- •non-breastfeeding
- •serum ferritin <40 ng/ml
- •hemoglobin>=11g/dl
排除标准
- •Serum Ferritin >=40 ng/ml
- •Hemoglobin <11g/dl
- •Amenorrhea
- •Menopause
- •Iron deficiency anemia
- •Thalassemia
- •Hemochromatosis
- •Blood donors
- •Chronic gastric diseases
- •Renal diseases
- •Eating disorders
- •Allergy to any component of the study juices
- •Consumption of iron or ascorbic acid supplements within 4 month prior to participating in the study
结局指标
主要结局
Serum Ferritin
时间窗: monitored during 16 weeks
次要结局
- 25-hydroxycholecalciferol(monitored during 16 weeks)
- Serum transferrin(monitored during 16 weeks)
- Hemoglobin(monitored during 16 weeks)
- serum iron(monitored during 16 weeks)
- transferrin saturation(monitored during 16 weeks)
- soluble transferrin receptor(monitored during 16 weeks)
- zinc protoporphyrin(monitored during 16 weeks)
- Total red blood cells(monitored during 16 weeks)
- Hematocrit(monitored during 16 weeks)
- Mean corpuscular volume(monitored during 16 weeks)
- Red blood cell distribution width(monitored during 16 weeks)
- alkaline phosphatase bone-isoenzyme (ALP)(monitored during 16 weeks)
- serum cross-linked N-telopeptide of type I collagen (NTx)(monitored during 16 weeks)
- Total cholesterol(monitored during 16 weeks)
- HDL-cholesterol(monitored during 16 weeks)
- LDL-cholesterol(monitored during 16 weeks)
- Glucose(monitored during 16 weeks)
- Serum triacylglycerols(monitored during 16 weeks)
- T-chol/HDL-chol(monitored during 16 weeks)
- LDL-chol/HDL-chol(monitored during 16 weeks)
- Systolic blood pressure(monitored during 16 weeks)
- Diastolic blood pressure(monitored during 16 weeks)
研究者
M Pilar Vaquero
Scientific Researcher
National Research Council, Spain
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