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

NCT00495690 | Completed Phase 3

• 1 other identifier: 5/7/46/03-RHN
• Study Type: interventional
• Target: 2,012
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia; Diarrhea; Meningitis; Sepsis; Death

Keywords

Zinc recipients; Placebo recipients

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• a) Adverse effect of zinc supplementation including diarrhea, vomiting fever and others. b) Impact of zinc on growth

  4 weeks to 6 months of age for each child under study

Interventions

Oral zinc gluconate (5 mg elemental) DRUG

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.

Eligibility Criteria

• Age: 3 Weeks - 4 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Society for Applied Studies: lead
• Indian Council of Medical Research: collaborator

Study Sites (1)

M.R. Bangur Hospital

Kolkata, Government West Bengal, 700 033, India

Location

MeSH Terms

Conditions

Pneumonia; Diarrhea; Meningitis; Sepsis; Death

Interventions

gluconic acid

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuroinflammatory Diseases; Nervous System Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes

Study Officials

• Dr. Dilip Mahalanabis, MBBS

  Reviewed and approved by the Ethics Review Committee of the Society for Applied Studies (FWA 00001757)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2007
• First Posted: July 3, 2007
• Study Start: November 1, 2004
• Primary Completion: November 1, 2007
• Study Completion: May 1, 2008
• Last Updated: September 15, 2011

Record last verified: 2011-09

Locations

IN (1)