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

Primary Purpose

Morbidity, Mortality, Diarrhea

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Zinc and iron folic acid - Intervention
Iron Folic Acid alone - Placebo
Sponsored by
Society for Applied Studies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Morbidity focused on measuring zinc supplementation, hospitalisations, children, mortality, iron folic acid

Eligibility Criteria

1 Month - 35 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    - 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,
    - 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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    December 22, 2005
    Last Updated
    June 30, 2008
    Sponsor
    Society for Applied Studies
    Collaborators
    World Health Organization, All India Institute of Medical Sciences, New Delhi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00269542
    Brief Title
    Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months
    Official Title
    Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2002 (undefined)
    Primary Completion Date
    March 2003 (Actual)
    Study Completion Date
    August 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Society for Applied Studies
    Collaborators
    World Health Organization, All India Institute of Medical Sciences, New Delhi

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Morbidity, Mortality, Diarrhea, Pneumonia
    Keywords
    zinc supplementation, hospitalisations, children, mortality, iron folic acid

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    94359 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Zinc and iron folic acid - Intervention
    Intervention Description
    The intervention group tablet contained 10 mg of elemental zinc, 12.5 mg of iron and 50 micrograms of folic acid.
    Intervention Type
    Drug
    Intervention Name(s)
    Iron Folic Acid alone - Placebo
    Intervention Description
    The control group tablets were similar in composition, appearance and taste except it contained placebo for zinc.
    Primary Outcome Measure Information:
    Title
    - 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,
    Time Frame
    3 monthly home visits
    Title
    - 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.
    Time Frame
    3 monthly home visits
    Secondary Outcome Measure Information:
    Title
    - the proportion of stunted or underweight children at end study
    Time Frame
    Baseline and end study after 12 months
    Title
    - the proportion of zinc deficient (plasma zinc <60 mg/dl) children at end study
    Time Frame
    Baseline and end study after 12 months
    Title
    - the mean plasma copper and superoxide dismutase at end study
    Time Frame
    Baseline and end study after 12 months
    Title
    - the mean plasma ferritin and transferrin activity at end study
    Time Frame
    Baseline and end study after 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    35 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maharaj K Bhan, MD
    Organizational Affiliation
    Professor, Department of Pediatrics, All India Institute of Medical Sciences
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Nita Bhandari, PhD
    Organizational Affiliation
    Society for Applied Studies, New Delhi
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17182810
    Citation
    Bhandari N, Taneja S, Mazumder S, Bahl R, Fontaine O, Bhan MK; Zinc Study Group. Adding zinc to supplemental iron and folic acid does not affect mortality and severe morbidity in young children. J Nutr. 2007 Jan;137(1):112-7. doi: 10.1093/jn/137.1.112.
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