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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00495690
Recruitment Status : Completed
First Posted : July 3, 2007
Last Update Posted : September 15, 2011
Indian Council of Medical Research
Information provided by (Responsible Party):
Society for Applied Studies

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2012 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Exclusion criteria:

  1. Perinatal illness requiring hospital stay after birth for more than 7 days
  2. Written informed consent was not provided by parents
  3. Presence of gross congenital anomaly
  4. Resides at a distance that makes it difficult to reach for home visit (estimated time to reach in more than 3 hours)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00495690

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M.R. Bangur Hospital
Kolkata, Government West Bengal, India, 700 033
Sponsors and Collaborators
Society for Applied Studies
Indian Council of Medical Research
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Study Chair: Dr. Dilip Mahalanabis, MBBS Reviewed and approved by the Ethics Review Committee of the Society for Applied Studies (FWA 00001757)

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Responsible Party: Society for Applied Studies Identifier: NCT00495690    
Other Study ID Numbers: 5/7/46/03-RHN
First Posted: July 3, 2007    Key Record Dates
Last Update Posted: September 15, 2011
Last Verified: September 2011
Keywords provided by Society for Applied Studies:
Zinc recipients
Placebo recipients
Additional relevant MeSH terms:
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Birth Weight
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Pathologic Processes
Body Weight
Central Nervous System Diseases
Nervous System Diseases
Trace Elements
Growth Substances
Physiological Effects of Drugs