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临床试验/NCT00531674
NCT00531674已完成不适用

Efficacy of 3 Nutritional Supplements to Improve Diverse Outcomes in Children Under 2 Years of Age and Pregnant Women

Mexican National Institute of Public Health0 个研究点开始时间: 2005年9月1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
主要终点
Child linear growth and weight gain

研究概览

简要总结

The Mexican poverty alleviation program, Oportunidades provides a fortified food supplement to all beneficiary children under 2 years of age, and all pregnant and lactating women. Consumption of the supplements is well below recommended levels and the impact of the program on child growth and anemia is less than anticipated. This is likely due to a high degree of dilution by sharing of the supplements with other family members. We have also found evidence of a very high prevalence of overweight and obesity among beneficiaries of Oportunidades in both women and children.

Given the micronutrient content of the fortified food, it is likely that the impact of the program on child growth and the micronutrient status of women and children would improve considerable if the supplements were consumed daily in the recommended dose. This may be difficult, given the wide-spread sharing within households - something that has been identified by many beneficiary families as a desirable behavior. At the same time, we do not know whether daily consumption of the food, which contains approximately 20% of daily energy requirements, may contribute to undesirable weight gain in this population.

In this context, we have designed a cluster randomized controlled efficacy trail to compare the nutritional impact, acceptability and use of three nutritional supplements. Supplements were randomly assigned at the community level (n=54), and pregnant women (n=750) and children 6 to 12 mo of age (n=900) invited to participate. The principal objective of the study is to compare the impact of Sprinkles and Nutrisano/Nutrivida using syrup/pills as a positive control group, on child growth, weight gain and retention in pregnant women, and micronutrient status of women and children. We hypothesize that weight gain will be greater in the food group compared to the other two supplementation groups, but impacts on micronutrient status and length growth in children will be similar.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Investigator)

入排标准

年龄范围
6 Months 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Pregnant women before 27 wks pregnancy (Arm 1)
  • 18 yrs of age and older (Arm 1)
  • Children 6 to 12 mo of age (Arm 2)
  • Beneficiaries of the Oportunidades programa (Arm 1 and 2)

排除标准

  • Severe anemia (Arm 1 and 2)
  • Consuming other nutritional supplements and unwilling to descontinue use (Arm 1 and 2)

结局指标

主要结局

Child linear growth and weight gain

时间窗: 24 mo of age

Child height and weight at 24 mo of age and increment from baseline to 24 mo of age

Child hemoglobin concentration and anemia prevalence

时间窗: 10 mo of supplementation, at 24 mo of age, 6 mo after completion of supplementation (30 mo of age)

Pregnancy weight gain and weight retention

时间窗: 37 wks pregnancy, 1 and 3 mo postpartum

Hemoglobin concentration and anemia prevalence

时间窗: 37 wks pregnancy and 1 mo postpartum

次要结局

  • Language adquisition and motor milestone development in children(Throughout follow-up)
  • Acceptability and use of the supplements (women and children)(Children: after 2, 6 and 12 mo consumption; Women: following completion of trial and in pregnant women who did not participate in main study)
  • Physical activity in children(after 4 and 12 mo of supplementation)

研究者

发起方
Mexican National Institute of Public Health
申办方类型
Other Gov

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