Impact of Daily Zinc Supplementation to Infants Born With Low Birth Weight on Death and Severe Disease
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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 |
- 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 ]
- 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) |
-
Drug: Oral zinc gluconate (5 mg elemental)
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 4 Weeks |
| Genders Eligible for Study: | Both |
| 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:
- Perinatal illness requiring hospital stay after birth for more than 7 days
- Written informed consent was not provided by parents
- Presence of gross congenital anomaly
- 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| India | |
| 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) |
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:
|
Birth Weight Death Diarrhea Meningitis Pneumonia Sepsis Body Weight Signs and Symptoms Pathologic Processes Signs and Symptoms, Digestive Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases |
Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Infection Systemic Inflammatory Response Syndrome Inflammation Zinc Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013