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

This study has been completed.
Sponsor:
Collaborator:
Indian Council of Medical Research
Information provided by (Responsible Party):
Society for Applied Studies
ClinicalTrials.gov Identifier:
NCT00495690
First received: June 30, 2007
Last updated: September 14, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Pneumonia
Diarrhea
Meningitis
Sepsis
Death
Drug: Oral zinc gluconate (5 mg elemental)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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 for each subject and study ] [ Designated as safety issue: No ]

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 for each child under study ] [ Designated as safety issue: No ]
    Zinc


Enrollment: 2012
Study Start Date: November 2004
Study Completion Date: May 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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.
  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

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00495690

Locations
India
M.R. Bangur Hospital
Kolkata, Government West Bengal, India, 700 033
Sponsors and Collaborators
Society for Applied Studies
Indian Council of Medical Research
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

No publications provided

Responsible Party: Society for Applied Studies
ClinicalTrials.gov Identifier: NCT00495690     History of Changes
Other Study ID Numbers: 5/7/46/03-RHN
Study First Received: June 30, 2007
Last Updated: September 14, 2011
Health Authority: India: Indian Council of Medical Research

Keywords provided by Society for Applied Studies:
Zinc recipients
Placebo recipients

Additional relevant MeSH terms:
Death
Birth Weight
Meningitis
Pathologic Processes
Body Weight
Signs and Symptoms
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014