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Main
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Note: This record shows only the 20 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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01229579 |
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Date of registration:
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25/10/2010 |
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Primary sponsor: |
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Public title:
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Effect of Zinc Supplementation on Response to Oral Polio Vaccine in Infants in Pakistan
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Scientific title:
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Effect of Zinc Supplementation on Response to Oral Polio Vaccine in Infants in Pakistan: a Randomized, Controlled Trial |
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Date of first enrolment:
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May 2010 |
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Target sample size:
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320 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01229579 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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Countries of recruitment
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Pakistan
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 0 to 14 days of healthy newborns
Exclusion Criteria:
- Infants beyond 14 days of age
- Preterm infants (< 37 weeks gestation or < 2 kg birth weight).
Age minimum:
N/A
Age maximum:
14 Days
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Poliomyelitis
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Intervention(s)
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Drug: Placebo
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Drug: Zinc Sulfate
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Primary Outcome(s)
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Seroconversion rates of polio virus (type 1 and type 3), from blood samples collected at the time of recruitment, at 6 weeks and 18 weeks.
[Time Frame: From birth to 18 weeks]
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Secondary Outcome(s)
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Effect of zinc supplementation on growth of infants
[Time Frame: Day 14 to 18 weeks]
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Prevalence of excretion of poliovirus serotypes 1, 3 at 0 and 7 days after the administration of bOPV
[Time Frame: 18 and 19 Weeks]
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Secondary ID(s)
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1291-Peds/ERC-09
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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