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

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

Interventions

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.

Sponsors & Collaborators

• Indian Council of Medical Research

  collaborator OTHER_GOV

• Society for Applied Studies

  lead OTHER

Principal Investigators

• Dr. Dilip Mahalanabis, MBBS · Reviewed and approved by the Ethics Review Committee of the Society for Applied Studies (FWA 00001757)

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

3 Weeks

Max Age

4 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-11-30

Primary Completion

2007-11-30

Completion

2008-05-31

Countries

• India

Study Locations