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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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12 November 2012 |
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Main ID: |
NCT01583972 |
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Date of registration:
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14/04/2012 |
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Primary sponsor: |
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Public title:
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Efficacy of Newborn Vitamin A Supplementation in Improving Immune Function
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Scientific title:
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Efficacy of Newborn Vitamin A Supplementation in Improving Immune Function |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01583972 |
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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: Prevention
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Countries of recruitment
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Bangladesh
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Contacts
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Name:
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Shaikh M. Ahmad, Ph.D. |
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Address:
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Telephone:
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Email:
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smeahmad@icddrb.org |
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Affiliation:
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Name:
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Charles B. Stephensen, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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USDA, Western Human Nutrition Research Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Infant receiving OPV and BCG within 48 hr of birth
Exclusion Criteria:
- Mother is less than 18 years of age
- Infant is part of a multiple birth
- Infant will likely not remain in the study area for the next 4 months
- Infant has a condition precluding vaccination
- Infant is unable to breastfeed or drink other fluids
- Birth weight is less than 1.5 kg
Age minimum:
N/A
Age maximum:
48 Hours
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Vitamin A Deficiency
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Intervention(s)
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Dietary Supplement: Placebo
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Dietary Supplement: retinyl palmitate
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Primary Outcome(s)
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Antibody response to oral polio virus (OPV) immunization
[Time Frame: through 15 wk of age]
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bacterial translocation to blood
[Time Frame: through 15 wk of age]
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peripheral blood naive T-helper lymphocyte concentration
[Time Frame: through 15 wk of age]
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T-cell and antibody response to tetanus toxoid (TT) and hepatitis B virus (HBV) vaccinations given at 6, 10 and 14 wk of age
[Time Frame: through 15 wk of age]
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T-cell receptor excision circle (TREC) level in peripheral blood mononuclear cells (PBMC)
[Time Frame: through 15 wk of age]
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T-cell response to BCG (Bacillus Calmette-Guérin; to protect against tuberculosis) and oral polio virus (OPV) immunization
[Time Frame: through 15 wk of age]
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Thymus size measured by ultrasound
[Time Frame: through 15 wk of age]
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Secondary Outcome(s)
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bulging fontanelle
[Time Frame: 48 h after vitamin A dosing]
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vitamin A status by modified, relative dose-response (MRDR) test
[Time Frame: through 15 wk of age]
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Secondary ID(s)
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N3-TSA-003
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PR-10012
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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