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临床试验/NCT02319499
NCT02319499已完成3 期

Zinc, Iron and Vitamin A Supplementation for Infant Growth and Development, and the Contributing Role of Psychosocial Care

Indonesia University2 个研究点 分布在 1 个国家目标入组 800 人开始时间: 1998年8月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
800
试验地点
2
主要终点
Change in Length-for-Age Z-scores

研究概览

简要总结

Many Indonesian infants are already iron deficient before they reach the age of six months, which also determines the high prevalence of anemia among under-five children. Iron deficiency ultimately leads to anemia, and there is clear evidence that iron deficiency anemia during early childhood has a marked negative effect on child development and cognitive function (Lozoff et al.1991; Idjradinata & Pollitt, 1993). This negative impact on childhood development is one of the main reasons why iron deficiency during infancy should be prevented or treated.

Since diets low in iron is usually also low in zinc, zinc deficiency --which has negative consequence on growth-- is common in iron deficiency area. In Southeast Asia, the condition is exacerbated by the rich phytate content in the complementary foods which inhibits the absorption of iron as well as zinc (Gibson, 1994). Thus, combining both iron and zinc, hence, is expected to decrease both iron and zinc deficiencies and hence improve growth and development of the children.

Recently, there has been an emerging view which looks at the two-way relationship between nutrition, health, and psychosocial well-being. This concept is supported by studies on "positive deviance", a term used to refer to children who grow and develop well in impoverished environments where most children are victims of malnutrition and chronic illness (Zeitlin et al., 1990). The mechanism which helps to explain how psychosocial factors, such as the affect between mother and child, are associated with adequate growth and development: 'Psychological stress has a negative effect on the use of nutrients whereas psychological well-being stimulates the secretion of growth-promoting hormones. Pleasantly stimulating interactions can enhance the child's tendency to exercise its developing organ systems and hence to utilize nutrients for growth and development'.

Understanding how the psychosocial environment can promote or inhibit the benefit of supplementation intervention is necessary in order to have a better way of setting about providing supplements. In fact, many supplementation programs do not incorporate complementary program elements that would help to improve the health and psychosocial development of children at the same time that they improve nutritional status' (Myers, 1995). Looking from this perspective, not only will supplementation benefit the psychosocial development but also the psychosocial environment can promote the benefit of the supplementation on the nutritional status and developmental outcomes of infants.

The purpose of the study is to investigate whether multi-micronutrient supplementations (zinc+iron, zinc+iron+vit.A) have positive effect on infants' growth and developmental outcomes, and whether the effect is modified by psychosocial care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • 3 to 6 month old
  • predominantly breast-fed children (assuming the infants were already introduced complementary feedings as early as 4 months)
  • parental consent

排除标准

  • apparent congenital abnormalities

结局指标

主要结局

Change in Length-for-Age Z-scores

时间窗: Baseline and monthly thereafter until endline (6 month of intervention)

Length-for-Age Z-score

Change in Weight-for-Length Z-scores

时间窗: Baseline and monthly thereafter until endline (6 month of intervention)

Weight-for-Length Z-score

Change in Weight-for-Age Z-scores

时间窗: Baseline and monthly thereafter until endline (6 month of intervention)

Weight-for-Age Z-scores

Changes in Psychomotor Development Index

时间窗: Baseline and Endline (6 month of intervention)

PDI of Bayley Scale of Infant Development II

Changes in Mental Development Index

时间窗: Baseline and Endline (6 month of intervention)

MDI of Bayley Scale of Infant Development II

次要结局

  • Changes in Hemoglobin(Baseline and Endline (6 month of intervention))
  • Changes in serum zinc(Baseline and Endline (6 month of intervention))
  • Changes in serum retinol(Baseline and Endline (6 month of intervention))
  • Changes in serum ferritin(Baseline and Endline (6 month of intervention))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Umi Fahmida

Dr

Indonesia University

研究点 (2)

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