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

NCT00269542 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94359

Last updated 2008-07-01

No results posted yet for this study

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.

Conditions

Interventions

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.

DRUG

Iron Folic Acid alone - Placebo

The control group tablets were similar in composition, appearance and taste except it contained placebo for zinc.

Sponsors & Collaborators

  • World Health Organization

    collaborator OTHER

  • All India Institute of Medical Sciences

    collaborator OTHER

  • Society for Applied Studies

    lead OTHER

Principal Investigators

  • Maharaj K Bhan, MD · Professor, Department of Pediatrics, All India Institute of Medical Sciences

  • Nita Bhandari, PhD · Society for Applied Studies, New Delhi

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
1 Month
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2003-03-31
Completion
2003-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00269542 on ClinicalTrials.gov