NCT05333939已完成不适用
Investigating the Effect of Moringa Oleifera Leaf Powder on Breastmilk Quantity and Quality: a Double Blinded Randomized Placebo-controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Milk output
研究概览
简要总结
The overall objective is to obtain preliminary data on the effect of Moringa oleifera leaf supplementation (moringa) at 4g daily for four weeks compared to placebo to improve human milk quantity and quality and infant health. Hypothesis: Four grams of moringa daily by mouth compared to placebo will increase breastmilk output and percent of mother's own milk consumed by infant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •willing to breastfeed or pump for one week
- •willing to complete study activities (at minimum measure 24 hour pumped volume at start and end of capsules, take capsules daily, and answer questions)
- •has access to breastpump (in hospital and/or home)
- •English speaking
- •18 years or older
- •Gave birth between 2-6 weeks prior to study start
- •taking metoclopramide (trade name Reglan) currently or within 2 weeks of enrollment
- •taking moringa regularly or within 2 weeks of enrollment
- •breast surgery (amplification, reduction, or other)
- •breast condition: Insufficient Glandular tissue
- •unprescribed or street drug use at any point in pregnancy, or enrolled in rehab program or receiving addiction therapy
- •refuses to take 4 capsules twice daily within 2 days of study start
- •wishes to withdraw within 2 days of study start
- •28-36 and 7 weeks gestation (ie 37 weeks is too old)
- •2-6 weeks old
- •singleton birth
- •· any condition where breastmilk is clinically contraindicated
排除标准
- 未提供
研究组 & 干预措施
Moringa
Experimental
4 g moringa leaf powder in green capsules divided into 4 capsules twice daily x 7 days
干预措施: Moringa leaf powder (Dietary Supplement)
Control
Placebo Comparator
comparable weight green capsules with cornstarch divided into 4 capsules twice daily x 7 days
干预措施: Placebo (Other)
结局指标
主要结局
Milk output
时间窗: 7 days
24 hour milk output at 7 days
次要结局
- % mother's own milk consumed by infant(7 days)
研究者
Suzanna L Attia
Assistant Professor
University of Kentucky
研究点 (1)
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