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
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