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A double blind randomized controlled trial in neonates to determine the effect of vitamin A supplementation on immune
Suzanna L R McDonald1, Mathilde Savy, Anthony J C Fulford
1Medical Research Council (MRC) International Nutrition Group (ING), London School of Hygiene & Tropical Medicine (LSHTM), Keppel Street, WC1E 7HT, United Kingdom & MRC Keneba, London, The Gambia. Suzanna.McDonald@lshtm.ac.uk.
Insights
Neonatal vitamin A supplementation may impact infant immunity and vaccine response. This study investigated its effects on immune function and thymic maturation in Gambian infants, providing data to inform global health policies.
Area of Science:
- Immunology
- Public Health
- Pediatrics
Background:
- Vitamin A supplementation's effect on infant mortality varies by age, with neonatal supplementation yielding conflicting results.
- Immunological interactions between vitamin A and vaccines may explain age-pattern variations in efficacy.
- Limited data exists on the immunological sequelae of neonatal vitamin A supplementation.
Purpose of the Study:
- To investigate the immunological effects of neonatal vitamin A supplementation in The Gambia.
- To assess if vitamin A supplementation improves thymic maturation and systemic immune responses to routine immunizations.
- To gather data complementing larger trials on the effectiveness and safety of neonatal vitamin A supplementation.
Main Methods:
- A double-blind, randomized controlled trial involving 200 mother-infant pairs in The Gambia.
- Neonates received either 50,000 IU vitamin A or placebo within 48 hours of birth.
- Immunological outcomes, including T regulatory cells, thymus maturation, and B cell responses, were assessed up to 17 weeks.
Main Results:
- The study primarily assessed circulating T regulatory cells expressing gut homing receptors at 17 weeks.
- Secondary outcomes included thymus maturation and B cell immune responses.
- Morbidity and anthropometry were monitored throughout the first year.
Conclusions:
- Data from this trial will complement findings from larger randomized controlled trials in India, Tanzania, and Ghana.
- These combined data will inform global policy regarding neonatal vitamin A supplementation.
- The trial aims to contribute to understanding the effectiveness and safety of vitamin A supplementation for infant survival.
Background:
Vitamin A supplementation significantly reduces all-cause mortality when given between 6-59 months of age, but has a null or detrimental effect when given between 1-5 months. Studies of neonatal vitamin A supplementation conducted across Africa and South Asia have produced conflicting findings. These age-pattern variations might result from immunological interactions between vitamin A supplementation and vaccines. Knowledge on the potential immunological sequelae of human neonatal vitamin A supplementation is so scarce that the foremost aim of this study is to seek indicative data on aspects of immunity likely to be affected by neonatal vitamin A supplementation. The objective of this trial is to test whether human neonatal vitamin A supplementation modulates immune function including improved thymic maturation in infancy and improved systemic immune responses to routine immunization.
Methods/Design:
In an area of moderate vitamin A deficiency in a peri-urban area of The Gambia, 200 mother-infant pairs were enrolled in a double-blind randomised controlled trial. Within 48 hours of birth, neonates were randomised with stratification by birth weight and sex to receive either an oral dose of 50,000 IU vitamin A or placebo. Expanded Programme of Immunisation birth vaccinations were administered after supplementation, with subsequent vaccinations administered at 8, 12 and 16 weeks of age. A range of immunological outcomes were examined up to 17 weeks of age, with additional morbidity and anthropometry follow-up carried out throughout the first year of life. The primary endpoint of this trial is the frequency of circulating T regulatory (Treg) cells expressing gut homing receptors in infants at 17 week post-supplementation, with secondary outcomes including thymus maturation and B cell immune responses.
Discussion:
Indicative immunological data from this trial (and its Bangladeshi counterpart), will complement the larger randomised controlled trials (conducted in India, Tanzania and Ghana), on the effectiveness and safety of neonatal vitamin A supplementation in improving infant survival. Combined these trials, in addition to the existing trials, will inform policy.
Trial Registration:
clinicaltrials.gov NCT01476358.
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