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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01476358
Other study ID # RPC389
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received November 9, 2011
Last updated November 12, 2012
Start date November 2011

Study information

Verified date November 2012
Source London School of Hygiene and Tropical Medicine
Contact n/a
Is FDA regulated No
Health authority Gambia: Department of State for Health and Social Welfare
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 48 Hours
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Gambia Medical Research Council, The Gambia Unit Fajara

Sponsors (2)

Lead Sponsor Collaborator
London School of Hygiene and Tropical Medicine World Health Organization

Country where clinical trial is conducted

Gambia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of circulating Tregs expressing gut homing receptors in infant participants. 17 week post-supplementation No
Secondary Difference in Thymus size in infant participants Assessed by ultrasonic analysis. 1, 6, 12 and 17 weeks No
Secondary Difference in B cell immune responses after routine vaccination in infant participants Assessed as an increase in B cell numbers and activation status. 6 and 17 weeks No
Secondary Improved mucosal barrier function in infant participants Assessed by quantifying bacterial translocation into the blood. 6 and 17 weeks No
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