Impact of Daily Zinc Supplementation to Infants Born With Low Birth Weight on Death and Severe Disease
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|ClinicalTrials.gov Identifier: NCT00495690|
Recruitment Status : Completed
First Posted : July 3, 2007
Last Update Posted : September 15, 2011
Title: Impact of daily zinc supplementation to infants born with low birth weight on mortality and severe disease requiring hospitalization Background: Zinc supplementation was shown to prevent diarrhea and pneumonia in 6 month to 3 year old children. Little is known about the impact of zinc supplementation of low birth weight (LBW) babies during first 6 months of life.
Objective: The objectives were to determine the impact of daily zinc administration at 1RDA (5 mg) of elemental zinc to LBW infants on severe morbidity requiring hospitalization and on all cause mortality.
Design: In a double blind randomized placebo controlled trial 2012 hospital-born infants with a birth weight <2500 g were randomly assigned to receive zinc or placebo for 6 months. Zinc group received 5 mg elemental zinc as acetate daily from 4 weeks age. Cause specific hospitalization deaths, episodes of diarrhea, acute respiratory infections, other illness, visits to health care providers and hospital OPDs were ascertained by in-depth interview and from documents like prescriptions, hospital tickets, medicine cartons at 3 and 6 months of age.
Results: Number of infants with one or more diarrhea episodes was less by 17% (95% CI: 1% to 35%) in the zinc group but the numbers for ARI were similar in the two groups. The hospitalization rates due to all causes or diarrhea or ARI were similar in the two groups. Twelve in the zinc group and 9 in the placebo group died during 4 weeks to 6 months (p=0.36). We observed no significant difference for gain in weight and length at 3 months and 6 months between the groups. In a subgroup of infants the mean serum zinc concentration in the zinc group was 27% higher (p=0.004) than the placebo group.
Conclusion: Hospital born, low birth weight infants do not seem to derive worthwhile benefit from daily zinc supplementation of recommended dietary allowance for zinc in terms of morbidity and growth during first six months of life.
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia Diarrhea Meningitis Sepsis Death||Drug: Oral zinc gluconate (5 mg elemental)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2012 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Impact of Daily Zinc Supplementation to Infants Born With Low Birth Weight on Mortality and Severe Disease Requiring Hospitalization|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||May 2008|
- Drug: Oral zinc gluconate (5 mg elemental)
Each infant in the study received placebo or 5 mg of elemental zinc (1 RDA) as zinc acetate syrup once daily from 4 weeks of age till 6 months of age.
- 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 for each subject and study ]
- 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 for each child under study ]Zinc
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00495690
|M.R. Bangur Hospital|
|Kolkata, Government West Bengal, India, 700 033|
|Study Chair:||Dr. Dilip Mahalanabis, MBBS||Reviewed and approved by the Ethics Review Committee of the Society for Applied Studies (FWA 00001757)|