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临床试验/NCT04587271
NCT04587271已完成不适用

Investigating the Impact of Moringa Oleifera Leaf Supplementation on Growth, Nutrition, Lactation, and Inflammation in Kenyan Breastfeeding Mothers and Children

Suzanna L Attia4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
4
主要终点
Change in Body Weight

研究概览

简要总结

Studies to date on the effects of Moringa oleifera in diabetes and anemia and animal studies that examine the utility of moringa for increased milk and litter yield are of small scale, however high-quality large-scale placebo or case-controlled clinical trials to define the impact on infants of moringa leaf powder consumption by breastfeeding mothers are lacking. Moringa has a traditional and agricultural history of use as a galactagogue; despite this and its incorporation into products such as Mother's Milk Tea© and placement on NIH LactMed Lactation Database, this property has not been studied in large clinical trials nor in populations dependent on breastmilk such as in Kisumu, Kenya. This study will improve and add to existing knowledge of moringa's effect on human breastmilk and will provide novel information on the effect of moringa supplementation to lactating mothers on their infant's intestinal inflammation and health. After trial registration, the study was modified to include infant follow up to 18 months for some measures and the children's groups were removed. Although the study was modified to an 18 month follow up, the data were not able to be collected.

Further understanding of the acceptability of moringa leaf in a staple food of porridge and more the effect of moringa supplementation on infant and childhood growth, nutrition, and intestinal and systemic inflammation may translate in the future to the cultivation of moringa at the community or household level as an effective resource for the improvement of childhood undernutrition.

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
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • lactating women at least 18 years of age and their exclusively breastfed infants within 14 days of delivery.
  • children 6-59 months of age who eat food

排除标准

  • regular maternal consumption of moringa
  • receipt and consumption of food supplementation program
  • inability to feed orally or refusal to eat moringa or placebo porridge
  • for infants, prematurity (<36 weeks gestational age)
  • for infants, significant congenital disease
  • for infants, inability to feed orally

结局指标

主要结局

Change in Body Weight

时间窗: at baseline and 3 months

Body weight

次要结局

  • Change in the Soluble Transferrin Receptor(baseline and 3 months)
  • Change in Mid-Upper Arm Circumference(baseline and 3 months)
  • Change in Alpha-1-Antitrypsin(baseline and 3 months)
  • Change in Breastmilk Volume(at enrollment and at 3 months)
  • Change in Fecal Neopterin(baseline and 3 months)
  • Change in the Prevalence of Diarrhea(1 and 3 months)
  • Change in Fecal Myeloperoxidase(baseline and 3 months)
  • Change in Breastmilk Vitamin A(baseline and 3 months)
  • Change in Vitamin A(3 months)
  • Change in Infant Height(at baseline and 3 months)
  • Change in CRP Levels(baseline and 3 months)

研究者

发起方
Suzanna L Attia
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Suzanna L Attia

Assistant Professor

University of Kentucky

研究点 (4)

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