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临床试验/NCT02571764
NCT02571764已完成不适用

The Effect of Supplementary Food on Recovery From Moderate Acute Malnutrition in Pre-school Children in Rural Mexico

PepsiCo Global R&D1 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2015年9月最近更新:
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
248
试验地点
1
主要终点
Weight (kg) for height (cm) Z-score

研究概览

简要总结

Children with moderate acute malnutrition will be recruited in order to receive an intervention which consists in the consumption of a single serving of SF-cookies daily, 7-days a week for 12 months and 12 educational sessions on health and nutrition.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
2 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children (2-5 years old), who are from low socioeconomic classes (E and D classes),
  • reside in rural areas, and with WHZ- between > -3 and ≤ -2, and
  • informed consent given by the subject's mother or caregiver

排除标准

  • Severe acute malnutrition (HAZ, WAZ and WHZ-scores ≤-3) based on the 2006 World Health Organization (WHO) reference values (24)
  • Vitamin A deficiency (softening, ulceration, cloudiness of the cornea, and dryness of the conjunctivitis), and iodine deficiency (visible goiter)
  • (3 or more episodes of loose/liquid stools/per day and lasted more than 24-hours), fever (high temperature that lasted more than 24 hours as reported by the mother/caregiver), and respiratory infections (coughing and/or runny nose that last more than 24 hours).
  • Current consumption of other supplementary foods.
  • Peanut or other ingredient allergy based on prior report. If some direct family member is allergic to peanuts, child would not be enrolled.

研究组 & 干预措施

Nutritional Oats Cookie

Experimental

干预措施: Nutritional Oats Cookie (Other)

结局指标

主要结局

Weight (kg) for height (cm) Z-score

时间窗: 12 months

次要结局

  • Mid-upper arm circumference (cm) (MUAC)(12 hours)
  • height (cm) gain(12 months)
  • Weight (kg) gains(12 months)
  • weight (kg) for age (months) Z-score(12 months)
  • height (cm) for age (months) Z-score(12 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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