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
About this trial
This is an interventional prevention trial for Morbidity focused on measuring zinc supplementation, hospitalisations, children, mortality, iron folic acid
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.
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
NCT ID
NCT00269542
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
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.
Results Reference
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Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months
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