A Phase 2 interventional study of Vitamin A (retinyl palmitate). in Vitamin A Deficiency, sponsored by London School of Hygiene and Tropical Medicine. Status unknown at 1 site in Gambia. Open to participants aged 5 Hours to 48 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-11-14.
Sponsored by London School of Hygiene and Tropical Medicine · Phase 2 and Interventional
Vitamin A supplementation (VAS) significantly reduces all-cause mortality when given after 6 months of age, but has a null or detrimental effect when given between 1-5 months. Studies of neonatal VAS (NNVAS) have produced conflicting findings. These age-pattern variations might result from immunological interactions between VAS and vaccines. The potential efficacy of NNVAS is being retested in 3 large new intervention trials with mortality as endpoint. Complementary mechanistic studies in animals and in human infants in The Gambia (this proposal) and Bangladesh have been commissioned to run in parallel.
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.
67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 49 interventional studies indexed under Vitamin A Deficiency.
Browse Vitamin A Deficiency studies →London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Vitamin A (retinyl palmitate).
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.
Dietary Supplement: 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
Frequency of circulating Tregs expressing gut homing receptors in infant participants.
Time frame: 17 week post-supplementation
Difference in Thymus size in infant participants
Assessed by ultrasonic analysis.
Time frame: 1, 6, 12 and 17 weeks
Difference in B cell immune responses after routine vaccination in infant participants
Assessed as an increase in B cell numbers and activation status.
Time frame: 6 and 17 weeks
Improved mucosal barrier function in infant participants
Assessed by quantifying bacterial translocation into the blood.
Time frame: 6 and 17 weeks
The record gives a start of Nov 2011 and a primary completion of Jun 2013. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Retinol palmitate
London School of Hygiene and Tropical Medicine →