PneumoniaEcuaPAZNCT00513929
Zinc as Adjunct to Treatment of Pneumonia
A study testing Zinc sulphate in people with Pneumonia, run by Corporacion Ecuatoriana de Biotecnologia at 1 site in Ecuador.
Trial summary
The propose of this study is to evaluate if zinc given as an adjunct to standard treatment of severe pneumonia in young children shortens the duration and reduces treatment failure, and if these effects are pathogen-dependant. Read more about this study
- Who is it for?
- Ages 2 to 59 months
- Conditions the study is for
- Pneumonia
- What is being tested?
- Zinc sulphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteEcuador
- Study dates
- Aug 2007to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children from 2 to 59 months of age with severe pneumonia admitted to the Children´s Hospital, whose parents are willing to provide written informed consent will be eligible for participation
Who cannot join
- Children suffering from marasmus or kwashiorkor, measles, pneumonia due to aspiration of a foreign body, hepatic or renal disease, sepsis, congenital abnormalities (cardiac, renal, or genetic), complicated pneumonia (lung abscess, pleural effusion, pneumatocele, atelectasis), or severe anemia (hemoglobin less than 8 g/dL [this cut-off is based on clinical experience with severe anemia at high altitude])
- Children whose parents refuse to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
Ecuador1 site, 1 recruiting
- Recruiting
Baca Ortiz Children´s Hospitals
Quito
Fernando Sempértegui, MD
About this study
Official title: Effects of Zinc as an Adjunct to Treatment of Pneumonia in Young Children
The propose of this study is to evaluate if zinc given as an adjunct to standard treatment of severe pneumonia in young children shortens the duration and reduces treatment failure, and if these effects are pathogen-dependant.
Read the detailed description
Community-acquired pneumonia is a common and potentially serious infection that affects children worldwide. The annual incidence of pneumonia in children younger than five years of age is 34 to 40 cases per 1000 in Europe and North America, higher than at any other time of life [1]. In developing countries, pneumonia is not only more common than it is in the developed world (5 to 10% of all children < 5 years old), but also is more severe and is the largest cause of death in children [1, 2]. About 20% of deaths in children younger than five years of age are attributable to pneumonia (1.9 million deaths per year) [3]. More than 90% of these deaths are in resource-poor countries.
Zinc deficiency is widespread in developing countries and is recognized to impair growth and immune function [4]. Andean areas are included in the regions with the highest risk of zinc deficiency worldwide [5]. In Ecuador, 33% of children suffer from zinc deficiency. However, on the coast of Ecuador, where Guayaquil is located, the prevalence of zinc deficiency is 37% based on plasma zinc concentration below 70 micrograms/dl [6]. Stunting, which may result from chronic zinc undernutrition is present in 21.9% of children in Guayaquil [7]. In addition, in a previous study, we reported low dietary zinc intake in children from 12 to 59 months [8]. In urban areas of Ecuador, breast-feeding is not widely practiced, which could put very young children at risk of zinc deficiency [9]. Zinc is considered the most abundant intracellular micronutrient that participates in a wide range of cellular processes and plays a central role in the immune response to pathogens [10]. We previously demonstrated that zinc supplementation in Ecuadorian children caused an increased response to delayed type hypersensitivity tests to multiple pathogen-derived antigens [8].
There is no data available to determine whether the etiologies of pneumonia are dependent on a child´s zinc status. In general, bronchiolitis and upper respiratory tract infections are likely to be viral, whereas most cases of severe pneumonia and pneumonia-related deaths are more likely to be bacterial [1]. Recently, one in vitro study found that zinc mediates antiviral activity on respiratory syncytial virus (RSV), an etiological agent of pneumonia in children, by altering the ability of the cell to support RSV replication [11]. If zinc status has an influence on the etiology of pneumonia, this suggests that zinc deficiency might be associated with a "selective acquired immunodeficiency".
Meta-analyses have shown that zinc supplementation is useful for diarrhea and pneumonia prevention in developing countries [12, 13]. It has been extensively shown that zinc is an important adjunct to diarrhea treatment [13]. With regard to pneumonia, only three recent studies have reported the use of zinc as an adjunct to antimicrobial treatment for pneumonia in children. A clinical study performed in Kolkata, India, in children with acute lower respiratory infection who were given zinc supplements, demonstrated a significant reduction in the duration of fever and very ill status only in boys, but not in girls [14]. The weaknesses of this trial included the small sample size and the fact that the observed beneficial effect was based on a subgroup analysis. Another study performed in Vellore, India, in a larger group of children younger than 2 years of age, demonstrated that zinc, as an adjunct to antimicrobial treatment, did not have an overall effect on the duration of hospitalization or clinical signs associated with pneumonia [15]. In addition, Bose et al reported that the use of zinc was associated with an increased duration of clinical signs of pneumonia. These different findings could be explained by the dissimilarities between both geographical locations and mean basal plasma zinc concentrations in these studies (Kolkata: 63 µg/dl vs. Vellore: 72 µg/dl). Nevertheless, a clinical trial performed in Bangladesh reported that the use of zinc as an adjunct to the treatment of severe pneumonia in children reduced the duration of clinical manifestations of the disease including chest indrawing, tachypnea, hypoxia, and length of hospitalization [16]. This study had a sample size similar to the trial in Vellore [15] and thus had adequate power. In summary, there are conflicting results on the effect of zinc given during a severe pneumonia episode in young children. Pneumonia etiology is one factor that has been extensively discussed as a possible mechanism to explain the controversial findings of these studies. Bose et al. suggested that the increased duration of pneumonia signs during zinc supplementation might be due to different etiologies of pneumonia [15]. Brooks et al. speculated that the observed reductions in pneumonia duration might be explained by zinc's role in the acute phase response to pathogens [16]. However, at present there is no evidence showing that zinc supplementation has an etiology-dependent effect on the clinical evolution of pneumonia. In a recent editorial, Hambidge also suggested that the controversial findings from these three studies could be due to the basal zinc status of the intervention groups, associated pneumonia pathogens, and age of the enrolled children [17].
Consequently, to clarify the role of zinc in relation to pneumonia, our study will determine whether or not a low baseline zinc status is associated with the etiology of pneumonia. This potential finding may strengthen the scientific evidence that supports mass population zinc supplementation. Furthermore, this study will also establish if zinc used as treatment adjunct during a severe pneumonia episode results in more rapid clinical recovery from pneumonia. Moreover, our study intends to evaluate the effect of zinc, used as an adjunct to the treatment of pneumonia, on the clinical evolution in correlation with the etiology of pneumonia in Ecuadorian children when compared to placebo.
- Conditions
- Pneumonia
- Being tested
- Zinc sulphate
- Keywords
- Severe Pneumonia, Zinc, Associated pathogens, Severe Pneumonia by type of associated pathogens, Severe Pneumonia by basal plasma zinc status
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc sulphateDietary supplement
Arm X : Zinc sulphate 10 mg will be given orally twice a day since admission to resolution of pneumonia episode in addition to standard antibiotic treatment.
| Study group | Role | What they receive |
|---|---|---|
| X: Zinc sulphate | Experimental | Not described Receives: Dietary Supplement: Zinc sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (hours) to resolution of clinical signs of pneumonia
Measured: 31 months
Secondary outcomes (1)
Time (hours) to resolution of clinical signs of pneumonia by type of associated pathiogens ( bacterial/viral)
Measured: 31 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionMay 2010 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Ecuatoriana de Biotecnologia
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University
- Investigators
- Fernando E Sempertegui, MD, Principal investigator, Corporacion Ecuatoriana de Biotecnologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513929
- Sponsor's protocol ID
- TH-ZN-01-EC
- Acronym
- EcuaPAZ
- Status last verified
- Jan 2009
- First submitted
- 7 Aug 2007
- Last updated
- 29 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sempertegui F, Estrella B, Correa E, Aguirre L, Saa B, Torres M, Navarrete F, Alarcon C, Carrion J, Rodriguez, Griffiths JK. Effects of short-term zinc supplementation on cellular immunity, respiratory symptoms, and growth of malnourished Equadorian children. Eur J Clin Nutr. 1996 Jan;50(1):42-6.
PubMed 8617190Jonnalagadda S, Rodriguez O, Estrella B, Sabin LL, Sempertegui F, Hamer DH. Etiology of severe pneumonia in Ecuadorian children. PLoS One. 2017 Feb 9;12(2):e0171687. doi: 10.1371/journal.pone.0171687. eCollection 2017.
PubMed 28182741Sempertegui F, Estrella B, Rodriguez O, Gomez D, Cabezas M, Salgado G, Sabin LL, Hamer DH. Zinc as an adjunct to the treatment of severe pneumonia in Ecuadorian children: a randomized controlled trial. Am J Clin Nutr. 2014 Mar;99(3):497-505. doi: 10.3945/ajcn.113.067892. Epub 2014 Jan 15.
PubMed 24429536
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Zinc as an Adjunct to Treatment of Pneumonia in Young Children
- ClinicalTrials.gov ID
- NCT00513929
- Acronym / sponsor ID
- EcuaPAZ / TH-ZN-01-EC
- Conditions
- Pneumonia
- Keywords
- Severe Pneumonia, Zinc, Associated pathogens, Severe Pneumonia by type of associated pathogens, Severe Pneumonia by basal plasma zinc status
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Corporacion Ecuatoriana de BiotecnologiaUniversity, hospital or other
- Collaborators
- Boston University
- Study start
- Aug 2007
- Primary completion
- May 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 9 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The propose of this study is to evaluate if zinc given as an adjunct to standard treatment of severe pneumonia in young children shortens the duration and reduces treatment failure, and if these effects are pathogen-dependant.
Detailed description
Community-acquired pneumonia is a common and potentially serious infection that affects children worldwide. The annual incidence of pneumonia in children younger than five years of age is 34 to 40 cases per 1000 in Europe and North America, higher than at any other time of life [1]. In developing countries, pneumonia is not only more common than it is in the developed world (5 to 10% of all children < 5 years old), but also is more severe and is the largest cause of death in children [1, 2]. About 20% of deaths in children younger than five years of age are attributable to pneumonia (1.9 million deaths per year) [3]. More than 90% of these deaths are in resource-poor countries.
Zinc deficiency is widespread in developing countries and is recognized to impair growth and immune function [4]. Andean areas are included in the regions with the highest risk of zinc deficiency worldwide [5]. In Ecuador, 33% of children suffer from zinc deficiency. However, on the coast of Ecuador, where Guayaquil is located, the prevalence of zinc deficiency is 37% based on plasma zinc concentration below 70 micrograms/dl [6]. Stunting, which may result from chronic zinc undernutrition is present in 21.9% of children in Guayaquil [7]. In addition, in a previous study, we reported low dietary zinc intake in children from 12 to 59 months [8]. In urban areas of Ecuador, breast-feeding is not widely practiced, which could put very young children at risk of zinc deficiency [9]. Zinc is considered the most abundant intracellular micronutrient that participates in a wide range of cellular processes and plays a central role in the immune response to pathogens [10]. We previously demonstrated that zinc supplementation in Ecuadorian children caused an increased response to delayed type hypersensitivity tests to multiple pathogen-derived antigens [8].
There is no data available to determine whether the etiologies of pneumonia are dependent on a child´s zinc status. In general, bronchiolitis and upper respiratory tract infections are likely to be viral, whereas most cases of severe pneumonia and pneumonia-related deaths are more likely to be bacterial [1]. Recently, one in vitro study found that zinc mediates antiviral activity on respiratory syncytial virus (RSV), an etiological agent of pneumonia in children, by altering the ability of the cell to support RSV replication [11]. If zinc status has an influence on the etiology of pneumonia, this suggests that zinc deficiency might be associated with a "selective acquired immunodeficiency".
Meta-analyses have shown that zinc supplementation is useful for diarrhea and pneumonia prevention in developing countries [12, 13]. It has been extensively shown that zinc is an important adjunct to diarrhea treatment [13]. With regard to pneumonia, only three recent studies have reported the use of zinc as an adjunct to antimicrobial treatment for pneumonia in children. A clinical study performed in Kolkata, India, in children with acute lower respiratory infection who were given zinc supplements, demonstrated a significant reduction in the duration of fever and very ill status only in boys, but not in girls [14]. The weaknesses of this trial included the small sample size and the fact that the observed beneficial effect was based on a subgroup analysis. Another study performed in Vellore, India, in a larger group of children younger than 2 years of age, demonstrated that zinc, as an adjunct to antimicrobial treatment, did not have an overall effect on the duration of hospitalization or clinical signs associated with pneumonia [15]. In addition, Bose et al reported that the use of zinc was associated with an increased duration of clinical signs of pneumonia. These different findings could be explained by the dissimilarities between both geographical locations and mean basal plasma zinc concentrations in these studies (Kolkata: 63 µg/dl vs. Vellore: 72 µg/dl). Nevertheless, a clinical trial performed in Bangladesh reported that the use of zinc as an adjunct to the treatment of severe pneumonia in children reduced the duration of clinical manifestations of the disease including chest indrawing, tachypnea, hypoxia, and length of hospitalization [16]. This study had a sample size similar to the trial in Vellore [15] and thus had adequate power. In summary, there are conflicting results on the effect of zinc given during a severe pneumonia episode in young children. Pneumonia etiology is one factor that has been extensively discussed as a possible mechanism to explain the controversial findings of these studies. Bose et al. suggested that the increased duration of pneumonia signs during zinc supplementation might be due to different etiologies of pneumonia [15]. Brooks et al. speculated that the observed reductions in pneumonia duration might be explained by zinc's role in the acute phase response to pathogens [16]. However, at present there is no evidence showing that zinc supplementation has an etiology-dependent effect on the clinical evolution of pneumonia. In a recent editorial, Hambidge also suggested that the controversial findings from these three studies could be due to the basal zinc status of the intervention groups, associated pneumonia pathogens, and age of the enrolled children [17].
Consequently, to clarify the role of zinc in relation to pneumonia, our study will determine whether or not a low baseline zinc status is associated with the etiology of pneumonia. This potential finding may strengthen the scientific evidence that supports mass population zinc supplementation. Furthermore, this study will also establish if zinc used as treatment adjunct during a severe pneumonia episode results in more rapid clinical recovery from pneumonia. Moreover, our study intends to evaluate the effect of zinc, used as an adjunct to the treatment of pneumonia, on the clinical evolution in correlation with the etiology of pneumonia in Ecuadorian children when compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| X: Zinc sulphate | Experimental | Dietary Supplement: Zinc sulphate |
Who may qualify
- Ages
- 2 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children from 2 to 59 months of age with severe pneumonia admitted to the Children´s Hospital, whose parents are willing to provide written informed consent will be eligible for participation
Key exclusion criteria (2 listed)
- Children suffering from marasmus or kwashiorkor, measles, pneumonia due to aspiration of a foreign body, hepatic or renal disease, sepsis, congenital abnormalities (cardiac, renal, or genetic), complicated pneumonia (lung abscess, pleural effusion, pneumatocele, atelectasis), or severe anemia (hemoglobin less than 8 g/dL [this cut-off is based on clinical experience with severe anemia at high altitude])
- Children whose parents refuse to provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc sulphateArm X : Zinc sulphate 10 mg will be given orally twice a day since admission to resolution of pneumonia episode in addition to standard antibiotic treatment. | Dietary supplement | X: Zinc sulphate |
Primary outcome
Time (hours) to resolution of clinical signs of pneumonia
Time frame: 31 months
1 secondary outcome
Time (hours) to resolution of clinical signs of pneumonia by type of associated pathiogens ( bacterial/viral)
Time frame: 31 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2009.
- Background: PubMed 8617190Sempertegui F, Estrella B, Correa E, Aguirre L, Saa B, Torres M, Navarrete F, Alarcon C, Carrion J, Rodriguez, Griffiths JK. Effects of short-term zinc supplementation on cellular immunity, respiratory symptoms, and growth of malnourished Equadorian children. Eur J Clin Nutr. 1996 Jan;50(1):42-6.
- Derived from this study: PubMed 28182741Jonnalagadda S, Rodriguez O, Estrella B, Sabin LL, Sempertegui F, Hamer DH. Etiology of severe pneumonia in Ecuadorian children. PLoS One. 2017 Feb 9;12(2):e0171687. doi: 10.1371/journal.pone.0171687. eCollection 2017.
- Derived from this study: PubMed 24429536Sempertegui F, Estrella B, Rodriguez O, Gomez D, Cabezas M, Salgado G, Sabin LL, Hamer DH. Zinc as an adjunct to the treatment of severe pneumonia in Ecuadorian children: a randomized controlled trial. Am J Clin Nutr. 2014 Mar;99(3):497-505. doi: 10.3945/ajcn.113.067892. Epub 2014 Jan 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando E Sempertegui, MD principal investigator
Corporacion Ecuatoriana de Biotecnologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc sulphate in people with Pneumonia, run by Corporacion Ecuatoriana de Biotecnologia at 1 site in Ecuador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando E Sempertegui, MD (593 2 2520638, fersempert@andinanet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (hours) to resolution of clinical signs of pneumonia (time frame: 31 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00513929, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2009.