Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study

NCT00228254 | Completed Phase 4

• 2 other identifiers: R01HD038327-01R01HD038327
• Study Type: interventional
• Target: 2,582
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Pneumonia; Diarrhea; Acute Upper Respiratory Tract Infections

Keywords

acute respiratory infection; acute lower respiratory infection; diarrhea

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Zinc (12.5 mg/day) DRUG

vitamin A 10,000 IU per week DRUG

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead
• Corporacion Ecuatoriana de Biotecnologia: collaborator

Study Sites (2)

Tufts University School of Medicine

Boston, Massachusetts, 02111, United States

Location

Corporacion Ecuatoriana de Biotecnologia

Quito, Pinchincha, Ecuador

Location

Related Publications (1)

• 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.

  PMID: 36994923 DERIVED

MeSH Terms

Conditions

Pneumonia; Diarrhea

Interventions

Zinc; Vitamin A

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Jeffrey K Griffiths, MD MPH&TM

  Tufts University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 23, 2005
• First Posted: September 28, 2005
• Study Start: January 1, 2000
• Study Completion: June 1, 2004
• Last Updated: September 28, 2005

Record last verified: 2005-09

Locations

US (1); EC (1)