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Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months

30. juni 2008 opdateret af: Society for Applied Studies
Children, aged 1 months to 23 months, in the intervention households received zinc, iron and folic acid and those in the control households were administered iron and folic acid (IFA) alone for a period of one year. The primary outcomes were hospitalizations and deaths during this period.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Objective: Studies in developing countries show substantial reduction in diarrhoea and respiratory morbidity in young children receiving zinc supplementation. The impact of daily zinc supplementation coadministered with iron folic acid in young children on all cause hospitalisation and mortality in comparison with iron folic acid alone, was evaluated to help shape public policy.

Design: Randomised double blind trial

Setting: Low to middle socio-economic urban neighbourhoods of north and north-west Delhi in India

Participants: 94359 subjects aged 1 month to 23 months

Interventions: The subjects were administered dispersible tablets containing one recommended daily allowance of zinc and iron folic acid or iron folic acid alone, daily for 12 months after enrolment.

Main outcome measures: Hospitalisations were captured through passive surveillance of eight hospitals by trained study physicians. Deaths were ascertained through bimonthly visits to households.

Results: A third of the total children had low zinc levels (<60 mg/dL) and one fourth had iron deficiency (haematocrit <33%) at baseline. The proportion zinc deficient was significantly lower post 12 months supplementation, in the zinc and iron folic acid group (difference in proportions -10%; 95% confidence interval -15.6% to -4.4%, p 0.0005). Only 7.7% in the zinc and iron folic acid and 7.3% in the iron folic acid group had low haematocrit. Zinc and iron folic acid supplementation had no impact on hospitalisations, overall and cause-specific. The overall death rates were similar in the two groups.

Conclusions: The lack of mortality impact may be real or the findings could have resulted from the use of lower daily zinc dosing than in morbidity prevention trials or an interaction between zinc and iron whereby adding iron, may have adversely affected potential effects of zinc on immune function and morbidity. Future research should address iron and zinc interaction effects on important functional outcomes.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

94359

Fase

  • Ikke anvendelig

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

1 måned til 2 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age 1 months to 23 months
  • Either sex
  • Resident of study area

Exclusion Criteria:

  • Likely to leave the area during the study period
  • Non consent
  • Temporary exclusion criteria Illness requiring hospitalization Visible severe wasting. Visibly wasted children will be referred to a hospital for treatment. They will be eligible for enrollment only after effective rehabilitation.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Medicin: Zinc and iron folic acid - Intervention
The intervention group tablet contained 10 mg of elemental zinc, 12.5 mg of iron and 50 micrograms of folic acid.
Placebo komparator: 2
Medicin: Iron Folic Acid alone - Placebo
The control group tablets were similar in composition, appearance and taste except it contained placebo for zinc.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
- to determine the impact of daily oral supplementation of zinc (5 mg per day to infants aged less than 6 months and 10 mg per day to older children) and iron folic acid to children aged 1-23 months for a period of upto 12 months on all-cause mortality,
Tidsramme: 3 monthly home visits
3 monthly home visits
- to determine the impact of daily oral supplementation of zinc and iron folic acid to children 1-23 months for a period of upto 12 months on overall and diarrhea and pneumonia specific hospital admissions.
Tidsramme: 3 monthly home visits
3 monthly home visits

Sekundære resultatmål

Resultatmål
Tidsramme
- the proportion of stunted or underweight children at end study
Tidsramme: Baseline and end study after 12 months
Baseline and end study after 12 months
- the proportion of zinc deficient (plasma zinc <60 mg/dl) children at end study
Tidsramme: Baseline and end study after 12 months
Baseline and end study after 12 months
- the mean plasma copper and superoxide dismutase at end study
Tidsramme: Baseline and end study after 12 months
Baseline and end study after 12 months
- the mean plasma ferritin and transferrin activity at end study
Tidsramme: Baseline and end study after 12 months
Baseline and end study after 12 months

Samarbejdspartnere og efterforskere

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

Sponsor

Society for Applied Studies

Samarbejdspartnere

All India Institute of Medical Sciences, New Delhi
World Health Organization

Efterforskere

  • Ledende efterforsker: Nita Bhandari, PhD, Society for Applied Studies, New Delhi
  • Ledende efterforsker: Maharaj K Bhan, MD, Professor, Department of Pediatrics, All India Institute of Medical Sciences

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. februar 2002

Primær færdiggørelse (Faktiske)

1. marts 2003

Studieafslutning (Faktiske)

1. august 2003

Datoer for studieregistrering

Først indsendt

22. december 2005

Først indsendt, der opfyldte QC-kriterier

22. december 2005

Først opslået (Skøn)

23. december 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. juli 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2008

Sidst verificeret

1. juni 2008

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 00002
  • C6-181-429

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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