Trial record 1 of 1 for:    NCT01476358
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Effect of Vitamin A Supplementation on Immune Responses in Human Neonates (NNVAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01476358
First received: November 9, 2011
Last updated: November 12, 2012
Last verified: November 2012

November 9, 2011
November 12, 2012
November 2011
June 2013   (final data collection date for primary outcome measure)
Frequency of circulating Tregs expressing gut homing receptors in infant participants. [ Time Frame: 17 week post-supplementation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01476358 on ClinicalTrials.gov Archive Site
  • Difference in Thymus size in infant participants [ Time Frame: 1, 6, 12 and 17 weeks ] [ Designated as safety issue: No ]
    Assessed by ultrasonic analysis.
  • Difference in B cell immune responses after routine vaccination in infant participants [ Time Frame: 6 and 17 weeks ] [ Designated as safety issue: No ]
    Assessed as an increase in B cell numbers and activation status.
  • Improved mucosal barrier function in infant participants [ Time Frame: 6 and 17 weeks ] [ Designated as safety issue: No ]
    Assessed by quantifying bacterial translocation into the blood.
Same as current
Not Provided
Not Provided
 
Effect of Vitamin A Supplementation on Immune Responses in Human Neonates
A Randomized Controlled Trial in Human Neonates to Determine the Effect of Vitamin A Supplementation on Immune Responses

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Vitamin A Deficiency
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

  • Active Comparator: 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.
    Intervention: Dietary Supplement: Vitamin A (retinyl palmitate).
  • Placebo Comparator: 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.
    Intervention: Dietary Supplement: Vitamin A (retinyl palmitate).
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
Not Provided
June 2013   (final data collection date for primary outcome measure)

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.
Both
up to 48 Hours
Yes
Contact information is only displayed when the study is recruiting subjects
Gambia
 
NCT01476358
RPC389
Yes
London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
World Health Organization
Principal Investigator: Suzanna LR McDonald, BSc (Hons) MSc PhD London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP