Sepsis Clinical Trial
Official title:
Impact of Daily Zinc Supplementation to Infants Born With Low Birth Weight on Mortality and Severe Disease Requiring Hospitalization
Verified date | September 2011 |
Source | Society for Applied Studies |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Indian Council of Medical Research |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 2012 |
Est. completion date | May 2008 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 4 Weeks |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
India | M.R. Bangur Hospital | Kolkata | Government West Bengal |
Lead Sponsor | Collaborator |
---|---|
Society for Applied Studies | Indian Council of Medical Research |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | a) All cause mortality during zinc supplementation over 4 weeks to 6 months of age b) Rate of severe illness requiring hospitalization | 4 weeks to 6 months of age for each subject and study | No | |
Secondary | a) Adverse effect of zinc supplementation including diarrhea, vomiting fever and others. b) Impact of zinc on growth | Zinc | 4 weeks to 6 months of age for each child under study | No |
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