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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT02044107
Date of registration: 21/01/2014
Prospective Registration: Yes
Primary sponsor: Center for Studies of Sensory Impairment, Aging and Metabolism
Public title: The Effectiveness of Co-packaging With Zinc to Improve Treatment of Diarrhea and Pneumonia in Guatemala Zinc10
Scientific title: Measuring the Effectiveness of Co-packaging to Improve Provider and Caregiver Behavior in the Treatment of Diarrhea With Zinc & ORS and Pneumonia With Zinc & Antibiotics for Children Under 5 Yrs From San Marcos, Guatemala
Date of first enrolment: February 2014
Target sample size: 320
Recruitment status: Not yet recruiting
URL:  http://clinicaltrials.gov/show/NCT02044107
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Guatemala
Contacts
Name:     Marieke Vossenaar, PhD
Address: 
Telephone:
Email:
Affiliation:  Center for Studies of Sensory Impairment, Aging and Metabolism
Name:     María del Rosario García Meza, MA
Address: 
Telephone:
Email:
Affiliation:  Center for Studies of Sensory Impairment, Aging and Metabolism
Name:     Marion Roche, PhD
Address: 
Telephone:
Email:
Affiliation:  Micronutrient Initiative
Name:     Noel W Solomons, MD
Address: 
Telephone:
Email:
Affiliation:  Center for Studies of Sensory Impairment, Aging and Metabolism
Name:     Marieke Vossenaar, PhD
Address: 
Telephone: 50259000045
Email: mvossenaar@hotmail.com
Affiliation: 
Name:     Marieke Vossenaar, phD
Address: 
Telephone: 50259000045
Email: mvossenaar@hotmail.com
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

- The child is aged between between 2 and 59 mo old (< 5 years old).

- The child is diagnosed with diarrhea or pneumonia at one of the selected public
health care centers.

- The caregiver accompanying the child to the public health care centers must live in
the same household.

Exclusion Criteria:

- Unwillingness to sign consent form.



Age minimum: 2 Months
Age maximum: 59 Months
Gender: Both
Health Condition(s) or Problem(s) studied
Pneumonia.
Diarrhea.
Intervention(s)
Behavioral: Co-packaging and counseling messages
Primary Outcome(s)
Percentage of caregivers who report giving zinc to child for at least 8 days. [Time Frame: 10 days]
Percentage of caregivers who administer zinc to child for at least 8 days. [Time Frame: 10 days]
Secondary Outcome(s)
Improved Provision of Care for Treatment of Diarrhea and Pneumonia [Time Frame: 6 months]
Secondary ID(s)
CeSSIAM_01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Micronutrient Initiative
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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