Impact of Daily Feeding of Food Sources of Cryptoxanthin (CX) and Beta-carotene (BC) on Plasma and Breast Milk Concentrations of CX, BC, and Retinol (VA) in Lactating Women With Marginal Vitamin A Status
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change in carotenoids in serum and breast milk
研究概览
简要总结
The study will assess the relative bioavailability and bioefficacy of cryptoxanthin (CX) and beta-carotene (BC) from food sources for increasing breast milk carotenoid and retinol concentrations in lactating Bangladeshi women.
详细描述
The specific aim is to compare the effects of orange-fleshed sweet potatoes and tangerines compared to white-fleshed sweet potatoes and vitamin A as retinyl palmitate on blood and breast milk cryptoxanthin (CX), beta-carotene (BC), and vitamin A (VA) concentrations by randomly assigning lactating Bangladeshi women to one of four treatment groups for 6 days/week for 3 weeks.
The investigators will also compare the relative vitamin A (VA) value of BC and CX from food sources by comparing the mean change in breast milk retinol concentrations of the groups that receive tangerines (CX) or orange-fleshed sweet potatoes (BC) with the mean change in breast milk retinol of the group that receives retinyl palmitate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Healthy women in Dhaka, Bangladesh
- •Lactating women in their 2nd or 3rd month of lactation who are planning to breast-feed at least 6 months
- •Breast-feeding only one infant
- •Age range 18 to 45 years
- •Not pregnant
- •Serum retinol concentrations >0.70 umol/L and <1.10 umol/L
- •Normal concentrations of CRP (<10 mg/L)
- •At least one arm vein deemed adequate for blood collection, as evaluated by a screening nurse.
- •Willing to consume the test foods daily 6 d/wk for one month
排除标准
- •Health status is not compatible with the inclusion criteria, such as screening blood chemistries indicative of vitamin A deficiency.
- •Severe anemia (Hb <9 mg/dL)
- •Current pregnancy
- •Must not have known allergy to citrus fruit (tangerines or mandarin oranges) or sweet potatoes
- •Must have no obvious psychological or sociological problems-such as alcoholism, drug abuse, or severe and acute mental illness that would influence their ability to sign an inform consent agreement or to participate in study duties and activities
结局指标
主要结局
Change in carotenoids in serum and breast milk
时间窗: 1 and 3 weeks
We will measure serum and breast milk beta-carotene, beta-cryptoxanthin, other carotenoids, and vitamins A and E.
次要结局
- Change in Dark adaptation(1 and 3 weeks)