PneumoniaPhase 4NCT00228254
Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study
A Phase 4 study testing Zinc (12.5 mg/day) and vitamin A 10,000 IU per week in people with Pneumonia and Diarrhea, run by Tufts University at 2 sites in 2 countries.
Trial summary
Children with malnutrition are often low in some nutrients, like zinc or vitamin A, that could help them fight off infections like pneumonia. Our study was designed to see if children who got supplements of zinc or vitamin A had fewer infections. Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Diarrhea, Acute Upper Respiratory Tract Infections
- What is being tested?
- Zinc (12.5 mg/day) and vitamin A 10,000 IU per week
- How many people
- 2,582 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2000to Jun 2004
- Phase
- Phase 4
- 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 6 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 6 to 36 months at the time of enrollment No recent vitamin or micronutrient use Residence of 1 year or longer in the neighborhood Full and free written consent No clinical evidence of zinc or vitamin A deficiency Absence of severe malnutrition such as weight < or = to 60% of expected weight
- -
Who cannot join
- Age less than 6 months or greater than 36 months at enrollment Recent vitamin or micronutrient use Residence for less than 1 year in neighborhood Lack of full and free consent Any evidence of zinc or vitamin A deficiency Severe malnutrition
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Tufts University School of Medicine
Boston, Massachusetts, 02111
About this study
Children with malnutrition are often low in some nutrients, like zinc or vitamin A, that could help them fight off infections like pneumonia. Our study was designed to see if children who got supplements of zinc or vitamin A had fewer infections.
Read the detailed description
The Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) study was a multi-year nutritionally-stratified, placebo-controlled, double-blind study of low-dose vitamin A and/or zinc in 2,582 normal and malnourished urban children aged 6 to 36 months in Quito, Ecuador. Four group of ~ 645 children were enrolled in 2000, 2001, 2002, and 2003 with each child participating for up to 50 weeks. Children were visited 4 days each week. Outcome measures were pneumonia, other respiratory tract infections, diarrheal disease, and growth.
- Being tested
- Zinc (12.5 mg/day), vitamin A 10,000 IU per week
- Keywords
- acute respiratory infection, acute lower respiratory infection, diarrhea
- Medical subject headings
- Pneumonia, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc (12.5 mg/day)Drug
vitamin A 10,000 IU per weekDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute lower respiratory infection (pneumonia)
Growth
Secondary outcomes (3)
Additive or synergistic effects of zinc and vitamin A
Incidence of diarrheal disease
Incidence of other respiratory infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startJan 2000
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 2,582 participants
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Corporacion Ecuatoriana de Biotecnologia
- Investigators
- Jeffrey K Griffiths, MD MPH&TM, Principal investigator, Tufts University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228254
- Sponsor's protocol ID
- R01HD038327-01
- Other IDs
- R01HD038327
- Status last verified
- Sep 2005
- First submitted
- 23 Sep 2005
- Last updated
- 28 Sep 2005
- Results posted
- No
Publications
Imdad A, Rogner J, Sherwani RN, Sidhu J, Regan A, Haykal MR, Tsistinas O, Smith A, Chan XHS, Mayo-Wilson E, Bhutta ZA. Zinc supplementation for preventing mortality, morbidity, and growth failure in children aged 6 months to 12 years. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD009384. doi: 10.1002/14651858.CD009384.pub3.
PubMed 36994923
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study
- ClinicalTrials.gov ID
- NCT00228254
- Acronym / sponsor ID
- R01HD038327-01
- Keywords
- acute respiratory infection, acute lower respiratory infection, diarrhea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,582 participants
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Corporacion Ecuatoriana de Biotecnologia
- Study start
- Jan 2000
- Study completion
- Jun 2004
- First posted
- 28 Sep 2005 (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.
Children with malnutrition are often low in some nutrients, like zinc or vitamin A, that could help them fight off infections like pneumonia. Our study was designed to see if children who got supplements of zinc or vitamin A had fewer infections.
Detailed description
The Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) study was a multi-year nutritionally-stratified, placebo-controlled, double-blind study of low-dose vitamin A and/or zinc in 2,582 normal and malnourished urban children aged 6 to 36 months in Quito, Ecuador. Four group of ~ 645 children were enrolled in 2000, 2001, 2002, and 2003 with each child participating for up to 50 weeks. Children were visited 4 days each week. Outcome measures were pneumonia, other respiratory tract infections, diarrheal disease, and growth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 6 to 36 months at the time of enrollment No recent vitamin or micronutrient use Residence of 1 year or longer in the neighborhood Full and free written consent No clinical evidence of zinc or vitamin A deficiency Absence of severe malnutrition such as weight < or = to 60% of expected weight
- -
Key exclusion criteria (1 listed)
- Age less than 6 months or greater than 36 months at enrollment Recent vitamin or micronutrient use Residence for less than 1 year in neighborhood Lack of full and free consent Any evidence of zinc or vitamin A deficiency Severe malnutrition
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 (12.5 mg/day) | Drug | – |
| vitamin A 10,000 IU per week | Drug | – |
Primary outcome
Incidence of acute lower respiratory infection (pneumonia)
Growth
3 secondary outcomes
Additive or synergistic effects of zinc and vitamin A
Incidence of diarrheal disease
Incidence of other respiratory infections
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2005.
- Derived from this study: PubMed 36994923Imdad A, Rogner J, Sherwani RN, Sidhu J, Regan A, Haykal MR, Tsistinas O, Smith A, Chan XHS, Mayo-Wilson E, Bhutta ZA. Zinc supplementation for preventing mortality, morbidity, and growth failure in children aged 6 months to 12 years. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD009384. doi: 10.1002/14651858.CD009384.pub3.
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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.
Jeffrey K Griffiths, MD MPH&TM principal investigator
Tufts University School of Medicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zinc (12.5 mg/day) and vitamin A 10,000 IU per week in people with Pneumonia and Diarrhea, run by Tufts University at 2 sites in 2 countries.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 28 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute lower respiratory infection (pneumonia). The study lists 2 primary outcomes in all. 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 NCT00228254, which also lists 1 linked publication.
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 28 Sep 2005.