Effect of Vitamin A Supplementation on Immune Responses in Human Neonates

Status Active, not recruiting

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.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01476358
Study type	Interventional
Source	London School of Hygiene and Tropical Medicine
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	November 2011

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT03353662` - Sub Regional Micronutrient Survey in Ethiopia
Completed	`NCT01061307` - An Efficacy Trial of Iron, Zinc and Vitamin A Fortified Rice in Children in Satun, Thailand	Phase 0
Completed	`NCT00082420` - Retinol Equivalence of Plant Carotenoids in Children	N/A
Completed	`NCT03383744` - Using Stable Isotopes to Assess the Effectiveness of Vitamin A Supplementation in Cameroon	N/A
Recruiting	`NCT04438200` - Liver and Bone Retinol Levels in Guatemalan Adolescents and Adults
Not yet recruiting	`NCT06450925` - Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.	N/A
Completed	`NCT02996513` - Assessing Model Parameters for Applying the Retinol Isotope Dilution (RID) Method	N/A
Completed	`NCT02027610` - Vitamin A, Stool Microbiota and Vaccine Response in Bangladeshi Infants	N/A
Completed	`NCT01922713` - Effect of Daily Consumption of Orange Maize on Breast Milk Retinol in Lactating Zambian Women	N/A
Completed	`NCT02043223` - Stopping Postpartum Vitamin A Supplementation: Missing Concealed Benefit	Phase 2/Phase 3
Completed	`NCT05882682` - Impact of Food-to-Food Fortified Cereal Products on Diet Quality in Eldoret, Kenya
Completed	`NCT04632771` - Nutritional Status and Bouillon Use in Northern Ghana
Completed	`NCT02760095` - Effects of EED on Zn Absorption and Retention in Children From a Standard Dose
Completed	`NCT04137354` - Iron and Vitamin A in School Children	N/A
Completed	`NCT00198718` - Single-dose Postpartum Vitamin A Supplementation of Mothers and Neonates	Phase 2
Not yet recruiting	`NCT04127968` - Efficacy and Safety of Vitamin A Treatment for Children With Sepsis	N/A
Completed	`NCT03640104` - Individualized Dietary Intervention in Breastfeeding Women: Body Weight and Vitamin A Stores	N/A
Completed	`NCT01614483` - Efficacy of Yellow Cassava to Improve Vitamin A Status of Kenyan School Children	N/A
Completed	`NCT02702622` - Vitamin A Equivalence of the Provitamin A in Biofortified Bananas	N/A
Completed	`NCT02804490` - Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Vitamin A Supplementation on Immune Responses in Human Neonates — NNVAS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms