NCT01739907已完成不适用
Iron-fortified Flavoured Skimmed Milk With or Without Vitamin D in Iron Deficient Women
National Research Council, Spain0 个研究点目标入组 109 人开始时间: 2012年1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
- 109
- 主要终点
- Ferritin changes over 16 weeks
研究概览
简要总结
Iron deficiency and vitamin D deficiencies are common in menstruating women. The present assay studied the influence of the consumption of a flavoured skimmed milk with iron (iron pyrophosphate) or with iron and vitamin D3 in iron deficient women on:
- Iron metabolism
- Biomarkers of bone remodelling
- Cardiovascular risk indexes
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
- Triple (Participant, 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 or smokers of ≤ 3 cigarettes/day
- •Non-pregnant
- •non-breast-feeding
- •Serum ferritin <30ng/mL
- •Haemoglobin ≥11g/dL
排除标准
- •Amenorrhea
- •Menopause
- •Any known health problems likely to influence iron status including iron-metabolism-related diseases (iron deficiency anaemia, thalassaemia, haemochromatosis)
- •Chronic gastric diseases (inflammatory bowel disease, Crohn disease, gastric ulcers, celiac disease, hemorrhagic diseases)
- •Renal disease or allergy to some of the components of the assay diary product.
- •Blood donors
- •Have regularly consumed iron or ascorbic acid supplements within the four months prior to participating in the intervention.
结局指标
主要结局
Ferritin changes over 16 weeks
时间窗: 16 weeks (Measures at 0, 4, 8, 12 and 16 weeks)
次要结局
- Haemoglobin changes over 16 weeks(16 weeks (Measures at 0, 4, 8, 12 and 16 weeks))
- Total erythrocytes changes over 16 weeks(16 weeks (Measures at 0, 4, 8, 12 and 16 weeks))
- Haematocrit changes over 16 weeks(16 weeks (Measures at 0, 4, 8, 12 and 16 weeks))
- Mean corpuscular volume changes over 16 weeks(16 weeks (Measures at 0, 4, 8, 12 and 16 weeks))
- Red blood cell distribution width changes over 16 weeks(16 weeks (Measures at 0, 4, 8, 12 and 16 weeks))
- Serum iron changes over 16 weeks(16 weeks (Measures at 0, 4, 8, 12 and 16 weeks))
- Serum transferrin changes over 16 weeks(16 weeks (Measures at 0, 4, 8, 12 and 16 weeks))
- Transferrin saturation changes over 16 weeks(16 weeks (Measures at 0, 4, 8, 12 and 16 weeks))
- Soluble transferrin receptor changes over 16 weeks(16 weeks (Measures at 0, 8, and 16 weeks))
- 25-hydroxyvitamin D changes over 16 weeks(16 weeks (Measures at 0, 8, and 16 weeks))
- Procollagen type 1 N-terminal propeptide (P1NP) changes over 16 weeks(16 weeks (measures at 0, 8 and 16 weeks))
- Cross-linked N-telopeptides of type I collagen (NTX) changes over 16 weeks(16 weeks (measures at 0, 8 and 16 weeks)
- Parathormone (PTH) changes over 16 weeks(16 weeks (measures at 0, 8 and 16 weeks)
- Total cholesterol changes over 16 weeks(16 weeks (Measures at 0, 8 and 16 weeks)
- LDL-cholesterol changes over 16 weeks(16 weeks (Measures at 0, 8 and 16 weeks))
- HDL-cholesterol changes over 16 weeks(16 weeks (Measures at 0, 8 and 16 weeks))
- Triglycerides changes over 16 weeks(16 weeks (Measures at 0, 8 and 16 weeks))
- Systolic blood pressure changes over 16 weeks(16 weeks (Measures at 0, 8 and 16 weeks))
- Diastolic blood pressure changes over 16 weeks(16 weeks (Measures at 0, 8 and 16 weeks))
- glucose changes over 16 weeks(16 weeks (Measures at 0, 8 and 16 weeks))
研究者
M Pilar Vaquero
Scientific researcher
National Research Council, Spain
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