Effect of Daily Bovine Lactoferrin Supplementation on Fetal Development and Iron Metabolism in Healthy Pregnant Women: A Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- iron-deficiency anemia morbility of pregnant women
研究概览
简要总结
To assess the effects of a lactoferrin supplemented formula on fetal development , iron metabolism and immunity in healthy pregnant women. One hundred and twenty healthy pregnant women (24<gestational weeks<26) are enrolled and randomly assigned to lactoferrin-supplemented formula group (active group) or normal formula group (control group, without lactoferrin supplementation). Subjects allocated in active group consume lactoferrin supplemented formula (85mg lactoferrin per 100g) 3 times a day (81g totally), while those in control group consume formula without lactoferrin supplementation (<6mg lactoferrin per 100g formula) according to the same schedule. Routine blood test including hemoglobin and serum ferritin, and food frequency questionnaire-based review and 24h*3 dietary record are performed every 4 weeks during intervention until delivery. Body weight of newborns are recorded after delivery. The differences in iron deficiency anemia morbility of pregnant women and anthropometric measurements of newborns between groups would be analyzed after completion of this study.
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
- 20 Years 至 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy pregnant women with gestational weeks between 24 and 26;
- •with hemoglobin concentration > 110g / L;
- •without indication of abortion;
- •without infectious disease or hereditary disease;
- •without iron supplementation before enrollment.
排除标准
- •with red blood count <3.5*10^12/L，hemoglobin concentration<110g/L or serum ferritin <20 μg/L；
- •diagnosed with gestational diabetes mellitus;
- •enrolled in other intervention study within past 1 month.
结局指标
主要结局
iron-deficiency anemia morbility of pregnant women
时间窗: every 4 weeks during intervention, namely 28th gestational weeks, 32nd gestational weeks, 36th gestational weeks and the day of delivery.
次要结局
- iron metabolism of pregnant women(every 4 weeks during intervention, namely 28th gestational weeks, 32nd gestational weeks, 36th gestational weeks and the day of delivery.)
- fetal growth and development(the day of delivery,recorded by nurse immediately)
- fetal development(the day of delivery, measured and recorded by nurse.)
- fetal growth(the day of delivery, recorded by nurse.)