Zinc, Iron, Vitamin A and Psychosocial Care for Child Growth and Development

NCT02319499 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2014-12-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Zinc Alone

Zn-alone group received 10 mg/day of elemental zinc (as zinc sulphate)

DIETARY_SUPPLEMENT

Iron and Zinc

Zn+Fe group received 10 mg/day of elemental zinc (as zinc sulphate) and 10 mg/day of elemental iron (as ferrous sulphate)

DIETARY_SUPPLEMENT

Iron, Zinc and Vitamin A

Zn+Fe+vit.A group received 10 mg/day of elemental zinc (as zinc sulphate) and 10 mg/day of elemental iron (as ferrous sulphate), plus 1,000 IU/day of vitamin A

OTHER

Placebo

Placebo group received no minerals/vitamin

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Umi Fahmida, PhD · South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition (SEAMEO-RECFON)

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1998-08-31
Primary Completion
1999-02-28

Countries

  • Indonesia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02319499 on ClinicalTrials.gov