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Sponsors and Collaborators: |
Society for Applied Studies World Health Organization All India Institute of Medical Sciences, New Delhi |
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Information provided by: | Society for Applied Studies |
ClinicalTrials.gov Identifier: | NCT00269542 |
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.
Condition | Intervention |
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Morbidity Mortality Diarrhea Pneumonia |
Drug: Zinc and iron folic acid - Intervention Drug: Iron Folic Acid alone - Placebo |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months |
Enrollment: | 94359 |
Study Start Date: | February 2002 |
Study Completion Date: | August 2003 |
Primary Completion Date: | March 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: 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.
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2: Placebo Comparator |
Drug: Iron Folic Acid alone - Placebo
The control group tablets were similar in composition, appearance and taste except it contained placebo for zinc.
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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.
Ages Eligible for Study: | 1 Month to 35 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Maharaj K Bhan, MD | Professor, Department of Pediatrics, All India Institute of Medical Sciences |
Principal Investigator: | Nita Bhandari, PhD | Society for Applied Studies, New Delhi |
Responsible Party: | All India Institute of Medical Sciences ( Dr. MK Bhan ) |
Study ID Numbers: | 00002, C6-181-429 |
Study First Received: | December 22, 2005 |
Last Updated: | June 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00269542 |
Health Authority: | India: Ministry of Health |
zinc supplementation hospitalisations children mortality iron folic acid |
Folic Acid Diarrhea Respiratory Tract Infections Respiratory Tract Diseases |
Lung Diseases Zinc Iron Pneumonia |
Vitamin B Complex Hematinics Therapeutic Uses Growth Substances Vitamins |
Hematologic Agents Physiological Effects of Drugs Trace Elements Micronutrients Pharmacologic Actions |