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Impact of Zinc Supplementation in Low Birth Weight Infants on Severe Morbidity, Mortality and Zinc Status: A Randomized Controlled Trial

NCT00272142 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2009-09-03

No results posted yet for this study

Summary

There are currently no interventions available to substantially reduce the incidence of low birth weight (LBW) apart from increasing the age at marriage, maternal iron supplementation and possibly improved energy intakes.

The current view of the medical and public health community in India is that the immediate focus should be on promoting survival and development of low birth weight infants who have nearly a 6 to 7 fold higher mortality during infancy than those with normal birth weight.

Low serum zinc is associated with increased incidence of diarrhea and pneumonia. There is sufficient evidence in under-threes that during acute illness, zinc supplementation (1-2 recommended dietary allowance \[RDA\]) reduces incidence of all episodes of diarrhea, severe diarrhea and pneumonia. A number of initial published trials also show significant effect of zinc treatment on pneumonia. With the large and consistent effects of zinc supplementation on the incidence and severity of infections, an effect on child mortality is likely.

Available literature suggests the distinct possibility of reduced neonatal and infant mortality in LBWs receiving 1 RDA of zinc daily. A pilot study in India showed a 54% reduction in mortality in LBW infants. These findings were based on a very small sample and therefore considered insufficient to change policy.

A positive impact in the proposed study will provide an important tool for reduction of infant mortality which is currently stagnant and government acceptance for such a program is likely to be very high. We, the researchers at the Society for Applied Studies, believe this study has the potential for decreasing infant mortality from its current level.

Conditions

Interventions

DRUG

Zinc

DRUG

Placebo

Sponsors & Collaborators

  • World Health Organization

    collaborator OTHER

  • Linda and Kenneth Pollin Foundation, Inc.

    collaborator OTHER

  • Society for Applied Studies

    lead OTHER

Principal Investigators

  • Nita Bhandari, PhD · Society for Applied Studies

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
14 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • India

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT00272142 on ClinicalTrials.gov