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

13. december 2014 opdateret af: Umi Fahmida, Indonesia University

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

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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

800

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Java
      • Jakarta, Java, Indonesien, 10430
        • South East Asian Ministers of Education Organization, Regional Center for Food and Nutrition (SEAMEO-RECFON)

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

3 måneder til 6 måneder (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Zinc Alone
Zinc Sulphate (10 mg Zn/day)
Zn-alone group received 10 mg/day of elemental zinc (as zinc sulphate)
Eksperimentel: Iron and Zinc
Ferrous Sulphate and Zinc Sulphate (10 mg/day of each zinc and iron)
Zn+Fe group received 10 mg/day of elemental zinc (as zinc sulphate) and 10 mg/day of elemental iron (as ferrous sulphate)
Eksperimentel: Iron, Zinc and Vitamin A
Ferrous Sulphate, Zinc Sulphate and Vitamin A (10 mg/day of each zinc and iron, plus 1,000 IU vitamin A/day)
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 komparator: Placebo
No minerals/vitamin
Placebo group received no minerals/vitamin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Length-for-Age Z-scores
Tidsramme: Baseline and monthly thereafter until endline (6 month of intervention)
Length-for-Age Z-score
Baseline and monthly thereafter until endline (6 month of intervention)
Change in Weight-for-Length Z-scores
Tidsramme: Baseline and monthly thereafter until endline (6 month of intervention)
Weight-for-Length Z-score
Baseline and monthly thereafter until endline (6 month of intervention)
Change in Weight-for-Age Z-scores
Tidsramme: Baseline and monthly thereafter until endline (6 month of intervention)
Weight-for-Age Z-scores
Baseline and monthly thereafter until endline (6 month of intervention)
Changes in Mental Development Index
Tidsramme: Baseline and Endline (6 month of intervention)
MDI of Bayley Scale of Infant Development II
Baseline and Endline (6 month of intervention)
Changes in Psychomotor Development Index
Tidsramme: Baseline and Endline (6 month of intervention)
PDI of Bayley Scale of Infant Development II
Baseline and Endline (6 month of intervention)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Hemoglobin
Tidsramme: Baseline and Endline (6 month of intervention)
measured for all subjects (200 per group)
Baseline and Endline (6 month of intervention)
Changes in serum zinc
Tidsramme: Baseline and Endline (6 month of intervention)
measured in sub-samples (65 subjects/group)
Baseline and Endline (6 month of intervention)
Changes in serum ferritin
Tidsramme: Baseline and Endline (6 month of intervention)
measured in sub-samples (65 subjects/group)
Baseline and Endline (6 month of intervention)
Changes in serum retinol
Tidsramme: Baseline and Endline (6 month of intervention)
measured in sub-samples (65 subjects/group)
Baseline and Endline (6 month of intervention)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 1998

Primær færdiggørelse (Faktiske)

1. februar 1999

Datoer for studieregistrering

Først indsendt

7. december 2014

Først indsendt, der opfyldte QC-kriterier

13. december 2014

Først opslået (Skøn)

18. december 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. december 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. december 2014

Sidst verificeret

1. december 2014

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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