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NCT02027610 · ClinicalTrials.gov registry record
Vitamin A, Stool Microbiota and Vaccine Response in Bangladeshi Infants
A clinical trial, sponsored by USDA, Western Human Nutrition Research Center.
- Completed
- Registry status
- 258
- Enrollment target
NCT02027610: Completed study, sponsored by USDA, Western Human Nutrition Research Center.
NCT02027610 is a clinical trial that has completed, run by USDA, Western Human Nutrition Research Center. The registered enrollment target is 258 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02027610 has completed, sponsored by USDA, Western Human Nutrition Research Center.
- COMPLETED
- Registry status
- 258 participants
- Enrollment target
Study Summary
Vitamin A deficiency (VAD) increases the risk of death from infections in infants and young children. The World Health Organization (WHO) recommends high-dose vitamin A supplementation (VAS) from 6-59 months of age to reduce the risk of death in countries where VAD is common. Such countries include Bangladesh, where this study is being conducted. While providing VAS at 6 months is recommended, providing VAS at birth may also decrease the risk of death since newborn infants are also at risk of VAD. VAS presumably reduces infant mortality by improving the immune response to infection and immunization. Vitamin A particularly affects the development and function of T cells, which develop in the thymus and are a key component of the memory response to infection and immunization. Vitamin A is important for development of an important class of T cells, regulatory T-cells, in the intestine. Regulatory T-cells prevent over-reaction of the immune system to substances the immune system might otherwise treat as harmful such as food or the healthy bacteria in the intestine. VAD could disrupt the normal colonization of the infant's intestinal tract and cause a condition called "dysbiosis" where abnormal bacteria flourish and adversely affect the infant's immune system. Dysbiosis may disrupt the immune response to injectable and oral vaccines. VAS at birth may prevent dysbiosis and thus improve immune function, response to vaccines, and child survival. The investigators recently completed an intervention trial in Bangladeshi infants (NCT01583972) examining the effect of VAS at birth on immune function and response to vaccines administered from birth to 14 wk of age. The present study will recruit infants who completed NCT01583972 when they are from 12 to 24 m of age to determine if VAS at birth affects the responses to these same vaccines when they are measured during the second year of life. The investigators will examine the effect of VAS at birth on gut microbiota measured earl
Primary Outcome
The concentration of naïve T-cells in peripheral blood will be measured once at 52 - 104 wk of age by flow cytometric analysis.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2014-10 |
| Est. Completion | 2015-09 |
What the finished NCT02027610 record still lists
NCT02027610 is an observational study that tracks outcomes without assigning an intervention. The registered 258 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02027610 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02027610 about?
NCT02027610 is a clinical study titled "Vitamin A, Stool Microbiota and Vaccine Response in Bangladeshi Infants". Vitamin A deficiency (VAD) increases the risk of death from infections in infants and young children. The World Health Organization (WHO) recommends high-dose vitamin A supplementation (VAS) from 6-59 months of age to reduce the risk of death in countries where VAD is common. Such countries include ...
What is the current status of trial NCT02027610?
This trial is currently completed. The enrollment target is 258 participants. The study started on 2014-10. Estimated completion is 2015-09.
Who is sponsoring clinical trial NCT02027610?
This trial is sponsored by USDA, Western Human Nutrition Research Center, which has 47 total clinical trials registered on ClinicalTrials.gov.
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