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NCT Number: NCT02319499

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

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.

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Key information

Age range

3 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition (SEAMEO-RECFON)

Jakarta, Java, 10430, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • apparent congenital abnormalities

Treatment and study plan

Zinc Alone

Dietary Supplement

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

Iron and Zinc

Dietary Supplement

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

Iron, Zinc and Vitamin A

Dietary Supplement

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

Placebo

Other

Placebo group received no minerals/vitamin

Primary outcomes

  1. Change in Length-for-Age Z-scores

    Time frame: Baseline and monthly thereafter until endline (6 month of intervention)

    Length-for-Age Z-score

  2. Change in Weight-for-Length Z-scores

    Time frame: Baseline and monthly thereafter until endline (6 month of intervention)

    Weight-for-Length Z-score

  3. Change in Weight-for-Age Z-scores

    Time frame: Baseline and monthly thereafter until endline (6 month of intervention)

    Weight-for-Age Z-scores

  4. Changes in Mental Development Index

    Time frame: Baseline and Endline (6 month of intervention)

    MDI of Bayley Scale of Infant Development II

  5. Changes in Psychomotor Development Index

    Time frame: Baseline and Endline (6 month of intervention)

    PDI of Bayley Scale of Infant Development II

Secondary outcomes

  1. Changes in Hemoglobin

    Time frame: Baseline and Endline (6 month of intervention)

    measured for all subjects (200 per group)

  2. Changes in serum zinc

    Time frame: Baseline and Endline (6 month of intervention)

    measured in sub-samples (65 subjects/group)

  3. Changes in serum ferritin

    Time frame: Baseline and Endline (6 month of intervention)

    measured in sub-samples (65 subjects/group)

  4. Changes in serum retinol

    Time frame: Baseline and Endline (6 month of intervention)

    measured in sub-samples (65 subjects/group)

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
1999
First posted
Dec 18, 2014
Registry last updated
Dec 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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