Stopping Postpartum Vitamin A Supplementation: Are we Missing Concealed Benefit?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Breast milk immune regulators
研究概览
简要总结
The purpose of this study is to evaluate the effect of post-partum maternal vitamin A supplementation on breast milk bioactive compounds and immune status, growth and morbidity of children in the first four months of life.
详细描述
The effect will be assessed by the milk and blood.
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 32 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women >-18 years of age with low-risk obstetric
排除标准
- •Pregnant women expecting a multiple birth
- •Take vitamin A supplements during postpartum apart from study intervention
- •Premature birth
- •Newborn babies with birth defects and / or other serious diseases
研究组 & 干预措施
Early postpartum vitamin A suppl.
Single dose 200,000 IU vitamin A supplementation at <3-day and placebo supplementation at 6-wk postpartum.
干预措施: Vitamin A (<3-day postpartum) (Dietary Supplement)
Late postpartum vitamin A suppl.
Placebo supplementation at <3-day and single dose 200,000 IU vitamin A supplementation at 6-wk postpartum.
干预措施: Vitamin A (6 wk postpartum) (Dietary Supplement)
Early & late postpartum vitamin A suppl
200,000 IU vitamin A supplementation, both at <3-day and 6-wk postpartum
干预措施: Vitamin A (<3-day and 6 wk postpartum) (Dietary Supplement)
No postpartum vitamin A suppl.
Placebo supplementation, both at <3-day and 6-wk postpartum.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Breast milk immune regulators
时间窗: Four months
immune regulators in breast milk e.g. B-cell activating factor (BAFF); IL-7; Lactoferrin; sCD14, sIgA and TGF-beta levels at three time points- 1. \< 3-day postpartum (before 1st dose of supplementation) 2. 7 wk postpartum (1wk after 2nd dose of supplementation) 3. 15 wk postpartum
次要结局
- Infant T helper cell immune responses(Four months)
- Infant vaccines (Hepatitis B, Tetanus and Oral polio) specific antibody responses(Four months)
- Infant innate immune responses(Four months)
- Relative abundance of infant gut microbial community and gut inflammatory markers(Four months)