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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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19 November 2012 |
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Main ID: |
NCT01476358 |
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Date of registration:
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09/11/2011 |
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Primary sponsor: |
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Public title:
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Effect of Vitamin A Supplementation on Immune Responses in Human Neonates
NNVAS |
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Scientific title:
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A Randomized Controlled Trial in Human Neonates to Determine the Effect of Vitamin A Supplementation on Immune Responses |
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Date of first enrolment:
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November 2011 |
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Target sample size:
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200 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01476358 |
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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)
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Countries of recruitment
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Gambia
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Contacts
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Name:
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Suzanna LR McDonald, BSc (Hons) MSc PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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London School of Hygiene and Tropical Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- singleton birth,
- birth weight =1,500g,
- mother over 18 years willing to participate and residency within the study area.
- Birth vaccinations and vitamin A supplement must be administered within 48 hours of
birth.
Exclusion Criteria:
- Infants having a congenital disease,
- a serious infection at birth
- an inability to feed (initially assessed by the lack of the suck reflex),
- mothers who are seriously ill at time of enrolment (defined as bed bound for more
than 24 hours),
- mother participating in other studies,
- mothers who are HIV positive.
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: Vitamin A (retinyl palmitate).
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Primary Outcome(s)
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Frequency of circulating Tregs expressing gut homing receptors in infant participants.
[Time Frame: 17 week post-supplementation]
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Secondary Outcome(s)
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Difference in B cell immune responses after routine vaccination in infant participants
[Time Frame: 6 and 17 weeks]
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Difference in Thymus size in infant participants
[Time Frame: 1, 6, 12 and 17 weeks]
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Improved mucosal barrier function in infant participants
[Time Frame: 6 and 17 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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