Immunomodulation by Zinc Supplementation in Children With Pneumonia

Summary

Pneumonia is one of the main causes of morbidity and mortality in the world, especially in developing countries like ours.

The National Health and Nutrition Survey of Mexico, in 2006 showed underweight in 472,890 (5%) children under five years, low height in 1,194,805 (12.7%) and wasting in153,000 (1.6%) children. Zinc is decreased in malnutrition and is an essential cofactor for many proteins involved in cellular processes. Zinc deficiency leads to a decrease in the number of T cells, the ratio of Th1 to Th2 cells and the production of Th1 cytokines such as interferon gamma, with alteration in T cell mediated immunity. In malnourished children zinc supplementation restores the immune response. Reports of zinc supplementation in children with pneumonia are controversial.

The aims of this study are to evaluate the immunomodulatory effect of zinc supplementation in the clinical course of children with pneumonia, to evaluate the lymphoproliferative and cytokine response in these children and to explore whether the viral or bacterial etiology is related to the clinical response to supplementation with this micronutrient.

A clinical, randomized, prospective, controlled, double blinded study will be carried out. Children from 1 month to 5 years of age will be included, with the clinical and / or radiological diagnosis of pneumonia that enter the emergency room of the participant institutions. Empirical treatment for pneumonia will begin and each patient will be randomized 1:1 in 2 groups. One will receive zinc supplementation and another a placebo (glucose). Samples will be taken to determine the etiology (nasal lavage for multiplex polymerase chain reaction for 16 respiratory viruses and 6 bacteria) and a blood sample to measure the cytokine pattern and the lymphoproliferative response. After 7 days of treatment, a second sample will be taken for immunological studies (cytokine pattern and lymphoproliferative response). The following parameters will be measured to evaluate the clinical evolution: respiratory rate, temperature, oxygen saturation, inability to eat, duration of cough, rales, temperature normalization time, normalization time of oxygen saturation, normalization time of the respiratory rate, hospitalization time and outcome (discharge due to clinical improvement or death). A correlation will be made between the improvement in clinical parameters and mortality in the zinc supplementation group and the probable bacterial or viral etiology.

Conditions

• Pneumonia
• Children, Only

Interventions

DRUG

Zinc sulfate

Zinc sulfate 10 mg for children younger than 1 year old, 20 mg for children older than 1 year old, will be diluted in 1 ml of sterile water and administered orally every day in the morning during hospitalization

OTHER

Glucose

The placebo group will receive glucose diluted in 1 ml of sterile water orally every day during hospitalization

Sponsors & Collaborators

• Hospital General de Mexico

  collaborator OTHER_GOV

• Hospital Pediatrico de Coyoacan

  collaborator UNKNOWN

• Universidad Nacional Autonoma de Mexico

  lead OTHER

Principal Investigators

• Rosa M Wong-Chew, MD, DSc · Facultad de Medicina, Universidad Nacional Autonoma de Mexico

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

1 Month

Max Age

5 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-29

Primary Completion

2016-02-18

Completion

2016-02-23

Countries

• Mexico

Study Locations