- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00269542
Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
The intervention group tablet contained 10 mg of elemental zinc, 12.5 mg of iron and 50 micrograms of folic acid.
|
Placebo Comparator: 2
|
The control group tablets were similar in composition, appearance and taste except it contained placebo for zinc.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
- 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
|
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.
Time Frame: 3 monthly home visits
|
3 monthly home visits
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
- the proportion of stunted or underweight children at end study
Time Frame: 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
Time Frame: Baseline and end study after 12 months
|
Baseline and end study after 12 months
|
- the mean plasma copper and superoxide dismutase at end study
Time Frame: Baseline and end study after 12 months
|
Baseline and end study after 12 months
|
- the mean plasma ferritin and transferrin activity at end study
Time Frame: Baseline and end study after 12 months
|
Baseline and end study after 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nita Bhandari, PhD, Society for Applied Studies, New Delhi
- Principal Investigator: Maharaj K Bhan, MD, Professor, Department of Pediatrics, All India Institute of Medical Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00002
- C6-181-429
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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