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Immunomodulation by Zinc Supplementation in Children With Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03690583
Recruitment Status : Completed
First Posted : October 1, 2018
Last Update Posted : October 1, 2018
Sponsor:
Collaborators:
Hospital General de Mexico
Hospital Pediatrico de Coyoacan
Information provided by (Responsible Party):
Rosa Maria Wong Chew, Universidad Nacional Autonoma de Mexico

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.


Condition or disease Intervention/treatment Phase
Pneumonia Children, Only Drug: Zinc sulfate Other: Glucose Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of the Immunomodulatory Effect of Zinc Supplementation on the Clinical Evolution of Children With Pneumonia
Actual Study Start Date : January 29, 2014
Actual Primary Completion Date : February 18, 2016
Actual Study Completion Date : February 23, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Zinc group
Zinc sulfate 10 mg in children younger than 1 year old, 20 mg in children older than 1 year old
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 Name: Zinc

Placebo Comparator: Placebo group
Glucose
Other: Glucose
The placebo group will receive glucose diluted in 1 ml of sterile water orally every day during hospitalization




Primary Outcome Measures :
  1. Time of improvement of respiratory distress [ Time Frame: 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 ]
    Hours since the admission to the hospital to disappear the respiratory distress

  2. Time of improvement of oxygen desaturation [ Time Frame: 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 ]
    Hours since the admission to the hospital to normalize the oxygen saturation

  3. Time of improvement of clinical symptoms (cough, rales) [ Time Frame: 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 ]
    Hours since the admission to the hospital to have improvement in clinical symptoms

  4. Time of improvement of fever [ Time Frame: From date of randomization util the date of first documented progression, assessed up to 10 days ]
    Hours to have normal temperature since the admission to the hospital

  5. Duration of hospitalization [ Time Frame: From date of randomization util the date of discharge or date of death from any cause, whichever came first, assessed up to 10 days ]
    Days for the discharge of the patient


Secondary Outcome Measures :
  1. Cytokines pattern measured by flow cytometry in blood samples [ Time Frame: From date of randomization until de date of discharge or date of death from any cause, whichever came first, assessed up to 10 days ]
    Th1 cytokines (interferon gamma, IL-2, tumor necrosis factor alfa) and Th2 cytokines (IL-4, IL-10, IL-6) will be determined in blood samples in 2 times: at the admission of the patient and at the discharge

  2. Lymphoproliferation measured by incorporation of a fluorochrome in lymphocytes stimulated with Concanavalin A [ Time Frame: From date of randomization until de date of discharge or date of death from any cause, whichever came first, assessed up to 10 days ]
    Blood draws will be taken at the hospital admission and at the discharge of the patient to measure the lymphoproliferative capacity of their lymphocytes by flow cytometry



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Ages Eligible for Study:   1 Month to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03690583


Locations
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Mexico
Hospital Pediatrico de Coyoacan
Mexico city, Ciudad De México, Mexico, 04500
Hospital General de Mexico
Mexico, Mexico, 06726
Sponsors and Collaborators
Universidad Nacional Autonoma de Mexico
Hospital General de Mexico
Hospital Pediatrico de Coyoacan
Investigators
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Principal Investigator: Rosa M Wong-Chew, MD, DSc Facultad de Medicina, Universidad Nacional Autonoma de Mexico

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rosa Maria Wong Chew, Professor B. Head of the Infectious Diseases Research Laboratory, Universidad Nacional Autonoma de Mexico
ClinicalTrials.gov Identifier: NCT03690583    
Other Study ID Numbers: CONACYT SALUD 2012-01-182274
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rosa Maria Wong Chew, Universidad Nacional Autonoma de Mexico:
Pneumonia
Zinc supplementation
Cytokines
Lymphoproliferation
Viruses
Respiratory bacteria
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Zinc
Zinc Sulfate
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Astringents
Dermatologic Agents