Impact of Zinc Supplementation in Low Birth Weight Infants on Severe Morbidity, Mortality and Zinc Status: A Randomized Controlled Trial

NCT00272142 | Completed

• 2 other identifiers: HNI 04002C6.181.488
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

There are currently no interventions available to substantially reduce the incidence of low birth weight (LBW) apart from increasing the age at marriage, maternal iron supplementation and possibly improved energy intakes. The current view of the medical and public health community in India is that the immediate focus should be on promoting survival and development of low birth weight infants who have nearly a 6 to 7 fold higher mortality during infancy than those with normal birth weight. Low serum zinc is associated with increased incidence of diarrhea and pneumonia. There is sufficient evidence in under-threes that during acute illness, zinc supplementation (1-2 recommended dietary allowance \[RDA\]) reduces incidence of all episodes of diarrhea, severe diarrhea and pneumonia. A number of initial published trials also show significant effect of zinc treatment on pneumonia. With the large and consistent effects of zinc supplementation on the incidence and severity of infections, an effect on child mortality is likely. Available literature suggests the distinct possibility of reduced neonatal and infant mortality in LBWs receiving 1 RDA of zinc daily. A pilot study in India showed a 54% reduction in mortality in LBW infants. These findings were based on a very small sample and therefore considered insufficient to change policy. A positive impact in the proposed study will provide an important tool for reduction of infant mortality which is currently stagnant and government acceptance for such a program is likely to be very high. We, the researchers at the Society for Applied Studies, believe this study has the potential for decreasing infant mortality from its current level.

Conditions

Diarrhea; Respiratory Infection; Low Birth Weight

Keywords

mortality; hospitalization; diarrhea; respiratory infection; low birth weight; morbidity

Outcome Measures

Primary Outcomes (2)

• all cause hospitalizations in comparison to infants receiving placebo.

  November 2004 to August 2007

• illnesses requiring visits to healthcare providers.

  November 2004 to August 2007

Secondary Outcomes (6)

• cause specific hospitalizations for diarrhea and acute lower respiratory infections

  November 2004 to August 2007

• cause specific health care provider visits for illness

  November 2004 to August 2007

• all cause mortality in the two groups

  November 2004 to August 2007

• the proportion of stunted or underweight infants at end study

  November 2004 to August 2007

• plasma zinc in a subgroup

  November 2004 to August 2007

Interventions

Zinc DRUG

Placebo DRUG

Eligibility Criteria

• Age: 14 Days - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants aged 14 to 28 days born after 37 weeks of gestation and weighing less than or equal to 2.5 kg at birth (\<10th percentile of the National Center for Health Statistics \[NCHS\] median birth weight)
• Either sex
• Resides within 7 km of the hospital

You may not qualify if:

• Likely to leave the area of residence within 6 months of enrollment
• Congenital malformations, congenital heart disease, metabolic disorders, renal diseases, etc.
• Non consent for participation
• Illness requiring hospitalization
• Twins
• Preterm

Sponsors & Collaborators

• Society for Applied Studies: lead
• World Health Organization: collaborator
• Linda and Kenneth Pollin Foundation, Inc.: collaborator

Study Sites (1)

Society for Applied Studies

New Delhi, National Capital Territory of Delhi, 110017, India

Location

Related Publications (1)

• Taneja S, Bhandari N, Rongsen-Chandola T, Mahalanabis D, Fontaine O, Bhan MK. Effect of zinc supplementation on morbidity and growth in hospital-born, low-birth-weight infants. Am J Clin Nutr. 2009 Aug;90(2):385-91. doi: 10.3945/ajcn.2009.27707. Epub 2009 Jun 24.

  PMID: 19553296 RESULT

MeSH Terms

Conditions

Diarrhea; Respiratory Tract Infections

Interventions

Zinc

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Nita Bhandari, PhD

  Society for Applied Studies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 3, 2006
• First Posted: January 4, 2006
• Study Start: January 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: September 3, 2009

Record last verified: 2009-09

Locations

IN (1)