Micronutrient-supplemented Milk Study in Women of Childbearing Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Increase in red blood cell folate concentration
研究概览
简要总结
The purpose of this study is to determine if consuming ANMUM Materna (a fortified milk product) over a 12-week period increases red blood cell folate concentrations in women of childbearing age in Singapore, compared to an equivalent amount of standard (unfortified) milk.
详细描述
Folic acid (~400 µg/day) taken around the time of conception significantly reduces the risk of a neural tube defect (NTD)-affected pregnancy. Strategies to reduce NTD with folic acid, include supplement use and food fortification. An attractive strategy for NTD prevention is the use of fortified foods targeted for use by women planning a pregnancy. Fonterra currently markets a fortified-milk (ANMUM Materna) in Asia, designed for use prior to and during pregnancy. This milk product, if consumed as directed, provides ~400 µg folic acid per day. It is not known whether ANMUM Materna will reduce NTD rate. However, in a case-control study the risk of NTD was inversely associated with maternal red blood cell (RBC) folate concentrations. Accordingly, if ANMUM Materna increases RBC folate, it could be expected to decrease NTD risk.
In this study, the ANMUM Materna fortified milk will be tested against a standard control (unfortified) milk over a 12 week period. The subjects will consume 75g of milk powder daily throughout the supplementation period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female 21-35 years old.
- •Able to understand the nature and purpose of the study, including potential risks and side effects.
- •Willing to consent to study participation and to comply with study requirements.
- •Negative Pregnancy test at screening
排除标准
- •Consumption of vitamins and/or mineral supplements known to contain folate 6 months prior.
- •Chronic disease.
- •Milk and/or lactose-intolerant.
- •Pregnancy in the last 12 months, or currently planning a pregnancy.
- •Prior history of NTD-affected pregnancy
- •Serum Folate deficiency
结局指标
主要结局
Increase in red blood cell folate concentration
时间窗: 12 weeks
To determine if consuming ANMUM Materna over a 12-week period increases red blood cell folate concentrations in women of childbearing age in Singapore, compared to an equivalent amount of standard (unfortified) milk.
次要结局
- Reduction in homocysteine concentration(12 weeks)
- Increase in plasma folate concentration(12 weeks)
- Increase in plasma vitamin B12 concentration(12 weeks)