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

Iron Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02319499
• Other study ID #: ZIAP
• Status: Completed
• Phase: Phase 3
• First received: December 7, 2014
• Last updated: December 13, 2014
• Start date: August 1998

Study information

• Verified date: December 2014
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. primary completion date: February 1999
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 6 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Development
• Iron Deficiency
• Zinc Deficiency

Intervention

Dietary Supplement:
• Zinc Alone
Zn-alone group received 10 mg/day of elemental zinc (as zinc sulphate)
• 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)
• 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

Locations

Country	Name	City	State
Indonesia	South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition (SEAMEO-RECFON)	Jakarta	Java

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (16)

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. — View Citation

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

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

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

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. — View Citation

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. — View Citation

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

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

Idjradinata P, Pollitt E. Reversal of developmental delays in iron-deficient anaemic infants treated with iron. Lancet. 1993 Jan 2;341(8836):1-4. — View Citation

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. Erratum in: Pediatrics 1988 May;81(5):683. — View Citation

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

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. — View Citation

Rosado JL, López P, Muñoz 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. — View Citation

Schultink W, Gross R. Iron deficiency alleviation in developing countries. Nutr Res Rev. 1996 Jan;9(1):281-93. doi: 10.1079/NRR19960015. — View Citation

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. — View Citation

Walravens PA, Chakar A, Mokni R, Denise J, Lemonnier D. Zinc supplements in breastfed infants. Lancet. 1992 Sep 19;340(8821):683-5. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Length-for-Age Z-scores	Length-for-Age Z-score	Baseline and monthly thereafter until endline (6 month of intervention)	No
Primary	Change in Weight-for-Length Z-scores	Weight-for-Length Z-score	Baseline and monthly thereafter until endline (6 month of intervention)	No
Primary	Change in Weight-for-Age Z-scores	Weight-for-Age Z-scores	Baseline and monthly thereafter until endline (6 month of intervention)	No
Primary	Changes in Mental Development Index	MDI of Bayley Scale of Infant Development II	Baseline and Endline (6 month of intervention)	No
Primary	Changes in Psychomotor Development Index	PDI of Bayley Scale of Infant Development II	Baseline and Endline (6 month of intervention)	No
Secondary	Changes in Hemoglobin	measured for all subjects (200 per group)	Baseline and Endline (6 month of intervention)	No
Secondary	Changes in serum zinc	measured in sub-samples (65 subjects/group)	Baseline and Endline (6 month of intervention)	No
Secondary	Changes in serum ferritin	measured in sub-samples (65 subjects/group)	Baseline and Endline (6 month of intervention)	No
Secondary	Changes in serum retinol	measured in sub-samples (65 subjects/group)	Baseline and Endline (6 month of intervention)	No