Immunomodulation by Zinc Supplementation in Children With Pneumonia

NCT03690583 | Completed Phase 1

• 1 other identifier: CONACYT SALUD 2012-01-182274
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Pneumonia; Zinc supplementation; Cytokines; Lymphoproliferation; Viruses; Respiratory bacteria

Outcome Measures

Primary Outcomes (5)

• Time of improvement of respiratory distress

  Hours since the admission to the hospital to disappear the respiratory distress

  From date of randomization util the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 days

• Time of improvement of oxygen desaturation

  Hours since the admission to the hospital to normalize the oxygen saturation

  From date of randomization util the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 days

• Time of improvement of clinical symptoms (cough, rales)

  Hours since the admission to the hospital to have improvement in clinical symptoms

  From date of randomization util the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 days

• Time of improvement of fever

  Hours to have normal temperature since the admission to the hospital

  From date of randomization util the date of first documented progression, assessed up to 10 days

• Duration of hospitalization

  Days for the discharge of the patient

  From date of randomization util the date of discharge or date of death from any cause, whichever came first, assessed up to 10 days

Secondary Outcomes (2)

• Cytokines pattern measured by flow cytometry in blood samples

  From date of randomization until de date of discharge or date of death from any cause, whichever came first, assessed up to 10 days

• Lymphoproliferation measured by incorporation of a fluorochrome in lymphocytes stimulated with Concanavalin A

  From date of randomization until de date of discharge or date of death from any cause, whichever came first, assessed up to 10 days

Study Arms (2)

Zinc group

EXPERIMENTAL

Zinc sulfate 10 mg in children younger than 1 year old, 20 mg in children older than 1 year old

Drug: Zinc sulfate

Placebo group

PLACEBO COMPARATOR

Glucose

Other: Glucose

Interventions

Zinc sulfate DRUG

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

Also known as: Zinc

Zinc group

Glucose OTHER

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

Placebo group

Eligibility Criteria

• Age: 1 Month - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 1 month to 5 years old with clinical and/or radiological diagnosis of pneumonia
• Admitted to the Emergency room at the participant institutions

You may not qualify if:

• Prematurity
• Cardiopathy
• Pneumopathy
• Immunosuppression (congenital, chemotherapy or other cause)

Sponsors & Collaborators

• Universidad Nacional Autonoma de Mexico: lead
• Hospital General de Mexico: collaborator
• Hospital Pediatrico de Coyoacan: collaborator

Study Sites (2)

Hospital Pediatrico de Coyoacan

Mexico City, Mexico City, 04500, Mexico

Location

Hospital General de Mexico

México, 06726, Mexico

Location

Related Publications (1)

• Acevedo-Murillo JA, Garcia Leon ML, Firo-Reyes V, Santiago-Cordova JL, Gonzalez-Rodriguez AP, Wong-Chew RM. Zinc Supplementation Promotes a Th1 Response and Improves Clinical Symptoms in Fewer Hours in Children With Pneumonia Younger Than 5 Years Old. A Randomized Controlled Clinical Trial. Front Pediatr. 2019 Nov 14;7:431. doi: 10.3389/fped.2019.00431. eCollection 2019.

  PMID: 31803694 DERIVED

MeSH Terms

Conditions

Pneumonia; Virus Diseases

Interventions

Zinc Sulfate; Zinc; Glucose

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Rosa M Wong-Chew, MD, DSc

  Facultad de Medicina, Universidad Nacional Autonoma de Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor B. Head of the Infectious Diseases Research Laboratory

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: October 1, 2018
• Study Start: January 29, 2014
• Primary Completion: February 18, 2016
• Study Completion: February 23, 2016
• Last Updated: October 1, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)