Impact of Daily Zinc Supplementation to Infants Born With Low Birth Weight on Death and Severe Disease - Full Text View

Purpose

Zinc is an essential element that pervades all aspects of biology and the populations in India are thought to be deficient in zinc. A preliminary study in India suggested that zinc supplementation of low birth weight (LBW: less than 2.5kg at birth) infants may reduce death. In a controlled trial the impact of daily zinc supplementation (1 RDA dose) in LBW infants on death and severe disease requiring hospitalization will be evaluated. LBW infants born in a large Government hospital in Kolkata, will be assigned to receive either a zinc syrup (5mgm elemental daily) or a placebo from 4 weeks to 6 months and the rate ratios for death and severe disease will be compared. If found beneficial, this targeted intervention will be an important public health tool for reducing infant mortality rate in India.

Condition	Intervention	Phase
Pneumonia Diarrhea Any Severe Illness All Cause Mortality	Drug: Oral zinc gluconate (5 mg elemental) or placebo	Phase III

MedlinePlus related topics:

Diarrhea Pneumonia

Drug Information available for:

D-Gluconic acid, monosodium salt Gluconic acid Manganese gluconate Zinc gluconate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Impact of Daily Zinc Supplementation to Infants Born With Low Birth Weight on Mortality and Severe Disease Requiring Hospitalization

Further study details as provided by Society for Applied Studies:

Primary Outcome Measures:

a) All cause mortality during zinc supplementation over 4 weeks to 6 months of age b) Rate of severe illness requiring hospitalization [ Time Frame: 4 weeks to 6 months of age ]

Secondary Outcome Measures:

a) Adverse effect of zinc supplementation including diarrhea, vomiting fever and others. b) Impact of zinc on growth [ Time Frame: 4 weeks to 6 months of age ]

Estimated Enrollment:	2000
Study Start Date:	November 2004
Estimated Study Completion Date:	April 2008

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 4 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Weight at birth less than 2500gm
The infant is likely to stay in the city for the next 6 months
Absence of gross congenital malformation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495690

Contacts


Contact: Dilip Mahalanabis, MBBS	+91-33-2358 8850	sas_kolkata@vsnl.net

Locations


India, Government West Bengal
	M.R. Bangur Hospital	Recruiting
	Kolkata, Government West Bengal, India, 700 033
	Contact: Dr. Amitava Sen, MD +91-33-2466 5577 amitavasen@vsnl.net
	Contact: Dr. Dilip Mahalanabis, MBBS +91-33-2358 8850 sas_kolkata@vsnl.net
	Sub-Investigator: Dr. Amitava Sen, MBBS

Sponsors and Collaborators

Society for Applied Studies

Investigators


Study Chair:	Dr. Dilip Mahalanabis, MBBS	Reviewed and approved by the Ethics Review Committee of the Society for Applied Studies (FWA 00001757)

More Information

Study ID Numbers:	5/7/46/03-RHN
First Received:	June 30, 2007
Last Updated:	July 2, 2007
ClinicalTrials.gov Identifier:	NCT00495690
Health Authority:	India: Indian Council of Medical Research

Study placed in the following topic categories:

Body Weight

Birth Weight

Signs and Symptoms

Death

Diarrhea

Respiratory Tract Infections

Respiratory Tract Diseases

Lung Diseases

Zinc

Pneumonia

ClinicalTrials.gov processed this record on November 06, 2008

Sponsored by:	Society for Applied Studies
Information provided by:	Society for Applied Studies
ClinicalTrials.gov Identifier:	NCT00495690