Effect of Vitamin A Supplementation on Immune Responses in Human Neonates
NCT ID: NCT01476358
Last Updated: 2012-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2011-11-30
Brief Summary
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The investigators will use a 2-arm double blind RCT to test whether NNVAS modulates the early ontogeny of human immune development. Neonates, recruited through a peri-urban clinic in The Gambia, will receive either 50,000 International Units (IU) VAS orally within 48 hours of birth (intervention group, n=100) or a placebo (control group, n=100). Male and female neonates will be randomized separately at enrolment for later analyses by sex. All infants will be followed up from birth to age 1 year. A broad panel of immunological outcomes will examine whether NNVAS: a). normalises thymic development (thymic index by ultrasound); b). skews mycobacterial and recall antigen responses towards a Th2 profile; c). diminishes Th1 and Th17 reactivity to mycobacterial and recall antigens; d). diminishes the tuberculin skin test (TST) response; e). causes increased innate immune reactivity; f). increases the frequency of circulating regulatory T cells (Tregs) expressing gut homing receptors; g). enhances B cell immune responses after routine vaccination (increase of B cell numbers and activation status); h). increases circulating IgA in mucosal immune compartment, especially oral polio vaccine (OPV) specific IgA post-vaccination; i). decreases bacterial translocation, by improving mucosal barrier function; and j). decreases markers of infection or inflammation. Growth and morbidity will also be assessed.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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Vitamin A
Capsule containing oil vehicle with Vitamin A (retinyl palmitate). Capsules are prepared by the manufacturer (Strides Arcolab Limited, India) and assigned blinded codes by World Health Organization officials.
Vitamin A (retinyl palmitate).
Active Comparator (Vitamin A): 1 capsule containing oil carrier and 50,000IU Vitamin A, within 48hs of birth
Placebo Comparator: 1 capsule containing oil carrier and 0IU Vitamin A, within 48hs of birth
Placebo
Capsule containing oil vehicle withOUT Vitamin A (retinyl palmitate). Capsules are prepared by the manufacturer (Strides Arcolab Limited, India) and assigned blinded codes by World Health Organization officials.
Vitamin A (retinyl palmitate).
Active Comparator (Vitamin A): 1 capsule containing oil carrier and 50,000IU Vitamin A, within 48hs of birth
Placebo Comparator: 1 capsule containing oil carrier and 0IU Vitamin A, within 48hs of birth
Interventions
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Vitamin A (retinyl palmitate).
Active Comparator (Vitamin A): 1 capsule containing oil carrier and 50,000IU Vitamin A, within 48hs of birth
Placebo Comparator: 1 capsule containing oil carrier and 0IU Vitamin A, within 48hs of birth
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
5 Hours
48 Hours
ALL
Yes
Sponsors
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World Health Organization
OTHER
London School of Hygiene and Tropical Medicine
OTHER
Responsible Party
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Principal Investigators
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Suzanna LR McDonald, BSc (Hons) MSc PhD
Role: PRINCIPAL_INVESTIGATOR
London School of Hygiene and Tropical Medicine
Locations
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Medical Research Council, The Gambia Unit
Fajara, , The Gambia
Countries
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References
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McDonald SL, Savy M, Fulford AJ, Kendall L, Flanagan KL, Prentice AM. A double blind randomized controlled trial in neonates to determine the effect of vitamin A supplementation on immune responses: The Gambia protocol. BMC Pediatr. 2014 Apr 4;14:92. doi: 10.1186/1471-2431-14-92.
Other Identifiers
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RPC389
Identifier Type: -
Identifier Source: org_study_id