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

NCT02319499 | Completed Phase 3

• 1 other identifier: ZIAP
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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

Development; Iron Deficiency; Zinc Deficiency

Outcome Measures

Primary Outcomes (5)

• Change in Length-for-Age Z-scores

  Length-for-Age Z-score

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

• Change in Weight-for-Length Z-scores

  Weight-for-Length Z-score

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

• Change in Weight-for-Age Z-scores

  Weight-for-Age Z-scores

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

• Changes in Mental Development Index

  MDI of Bayley Scale of Infant Development II

  Baseline and Endline (6 month of intervention)

• Changes in Psychomotor Development Index

  PDI of Bayley Scale of Infant Development II

  Baseline and Endline (6 month of intervention)

Secondary Outcomes (4)

• Changes in Hemoglobin

  Baseline and Endline (6 month of intervention)

• Changes in serum zinc

  Baseline and Endline (6 month of intervention)

• Changes in serum ferritin

  Baseline and Endline (6 month of intervention)

• Changes in serum retinol

  Baseline and Endline (6 month of intervention)

Study Arms (4)

Zinc Alone

EXPERIMENTAL

Zinc Sulphate (10 mg Zn/day)

Dietary Supplement: Zinc Alone

Iron and Zinc

EXPERIMENTAL

Ferrous Sulphate and Zinc Sulphate (10 mg/day of each zinc and iron)

Dietary Supplement: Iron and Zinc

Iron, Zinc and Vitamin A

EXPERIMENTAL

Ferrous Sulphate, Zinc Sulphate and Vitamin A (10 mg/day of each zinc and iron, plus 1,000 IU vitamin A/day)

Dietary Supplement: Iron, Zinc and Vitamin A

Placebo

PLACEBO COMPARATOR

No minerals/vitamin

Other: Placebo

Interventions

Zinc Alone DIETARY_SUPPLEMENT

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

Zinc Alone

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 and Zinc

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

Iron, Zinc and Vitamin A

Placebo OTHER

Placebo group received no minerals/vitamin

Placebo

Eligibility Criteria

• Age: 3 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• apparent congenital abnormalities

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

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

Jakarta, Java, 10430, Indonesia

Location

Related Publications (16)

• Schultink W, Gross R. Iron deficiency alleviation in developing countries. Nutr Res Rev. 1996 Jan;9(1):281-93. doi: 10.1079/NRR19960015. No abstract available.

  PMID: 19094274 BACKGROUND

• Colomer J, Colomer C, Gutierrez D, Jubert A, Nolasco A, Donat J, Fernandez-Delgado R, Donat F, Alvarez-Dardet C. Anaemia during pregnancy as a risk factor for infant iron deficiency: report from the Valencia Infant Anaemia Cohort (VIAC) study. Paediatr Perinat Epidemiol. 1990 Apr;4(2):196-204. doi: 10.1111/j.1365-3016.1990.tb00638.x.

  PMID: 2362876 BACKGROUND

• Lozoff B, Brittenham GM, Wolf AW, McClish DK, Kuhnert PM, Jimenez E, Jimenez R, Mora LA, Gomez I, Krauskoph D. Iron deficiency anemia and iron therapy effects on infant developmental test performance. Pediatrics. 1987 Jun;79(6):981-95.

  PMID: 2438638 BACKGROUND

• Idjradinata P, Pollitt E. Reversal of developmental delays in iron-deficient anaemic infants treated with iron. Lancet. 1993 Jan 2;341(8836):1-4. doi: 10.1016/0140-6736(93)92477-b.

  PMID: 7678046 BACKGROUND

• Brown KH, Wuehler SE and Peerson JM (2001). The importance of zinc in human nutrition and estimation of the global prevalence of zinc deficiency. Food Nutr Bull 22 (2):113-25

  BACKGROUND

• Gibson RS and Ferguson EL (1999). An Interactive 24-hour Recall for Assessing the Adequacy of Iron and Zinc Intakes in Developing Countries. ILSI Press, Washington DC

  BACKGROUND

• Ronaghy HA, Reinhold JG, Mahloudji M, Ghavami P, Fox MR, Halsted JA. Zinc supplementation of malnourished schoolboys in Iran: increased growth and other effects. Am J Clin Nutr. 1974 Feb;27(2):112-21. doi: 10.1093/ajcn/27.2.112. No abstract available.

  PMID: 4591425 BACKGROUND

• Walravens PA, Chakar A, Mokni R, Denise J, Lemonnier D. Zinc supplements in breastfed infants. Lancet. 1992 Sep 19;340(8821):683-5. doi: 10.1016/0140-6736(92)92229-9.

  PMID: 1355797 BACKGROUND

• Umeta M, West CE, Haidar J, Deurenberg P, Hautvast JG. Zinc supplementation and stunted infants in Ethiopia: a randomised controlled trial. Lancet. 2000 Jun 10;355(9220):2021-6. doi: 10.1016/S0140-6736(00)02348-5.

  PMID: 10885352 BACKGROUND

• Rosado JL, Lopez P, Munoz E, Martinez H, Allen LH. Zinc supplementation reduced morbidity, but neither zinc nor iron supplementation affected growth or body composition of Mexican preschoolers. Am J Clin Nutr. 1997 Jan;65(1):13-9. doi: 10.1093/ajcn/65.1.13.

  PMID: 8988907 BACKGROUND

• Cavan KR, Gibson RS, Grazioso CF, Isalgue AM, Ruz M, Solomons NW. Growth and body composition of periurban Guatemalan children in relation to zinc status: a longitudinal zinc intervention trial. Am J Clin Nutr. 1993 Mar;57(3):344-52. doi: 10.1093/ajcn/57.3.344.

  PMID: 8438768 BACKGROUND

• Bates CJ, Evans PH, Dardenne M, Prentice A, Lunn PG, Northrop-Clewes CA, Hoare S, Cole TJ, Horan SJ, Longman SC, et al. A trial of zinc supplementation in young rural Gambian children. Br J Nutr. 1993 Jan;69(1):243-55. doi: 10.1079/bjn19930026.

  PMID: 8457531 BACKGROUND

• Engle P and Ricciuti HN (1995). Psychosocial aspects of care and nutrition. Food Nutr Bull 16(4):356-77

  BACKGROUND

• Myers R (1995). The Twelve Who Survive: Strengthening Programmes of Early Childhood Development in the Thirld World. High/Scope Press, Michigan

  BACKGROUND

• Bayley (1993). Bayley Scales of Infant Development: Manual, 2nd ed. Harcourt Brace & Co., San Antonio

  BACKGROUND

• Caldwell BM and Bradley RH (1984). Home Observation for Measurement of the Environment. University of Arkansas, Little Rock - Arkansas

  BACKGROUND

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Zinc; Iron; Vitamin A

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Umi Fahmida, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 7, 2014
• First Posted: December 18, 2014
• Study Start: August 1, 1998
• Primary Completion: February 1, 1999
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

ID (1)