An observational study in Vitamin A Deficiency, sponsored by USDA, Western Human Nutrition Research Center. Completed at 3 sites in 2 countries. Open to participants aged 12 Months to 24 Months. Per ClinicalTrials.gov, last updated 2015-11-18.
Sponsored by USDA, Western Human Nutrition Research Center · Observational
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Among 16 studies in Vitamin A Deficiency with a site in United States — 5 open to participants now, 6 under way, 1 of them phase 3. Vitamin A Deficiency · United States.
Among the 16 studies in Vitamin A Deficiency with a site in United States, this one is one of 2 that started in 2014, is one of 4 observational ones, and was the 4th registered.
67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.
Browse Vitamin A Deficiency studies →5 of the 16 studies in Vitamin A Deficiency with a site in United States are open now. Recruiting first, the newest first:
Opus Genetics, Inc · Sites in United States
Ages 18+
University of Minnesota · Sites in United States
Ages 18–60 · Healthy volunteers
Children's Hospital Medical Center, Cincinnati · Sites in United States
Ages 18+
MD Stem Cells · Sites in United States, Austria, United Arab Emirates
Ages 18+
University of Mississippi Medical Center · Sites in United States
Ages 18–45
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 6 Vitamin A Deficiency studies recruiting now, 3 set no upper age limit and 3 stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 12 Months to 24 Months · all sexes · no healthy volunteers.
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16 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 2 started in 2014.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 258 is close to the median of 258 across 17 observational studies indexed under Vitamin A Deficiency.
Median enrollment 86 across the 12 interventional studies, 48 across the 4 observational. Of the 10 that completed or were terminated, 2 (20%) have results posted.
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3 of 16 have an industry lead sponsor. The 10 most frequent:
USDA, Western Human Nutrition Research Center is the lead sponsor of 54 studies on the registry; 1 is open to participants now.
USDA, Western Human Nutrition Research Center has 5 studies filed under Vitamin A Deficiency — fewer than ten, so there is no comparison to draw.
4 of the studies in Vitamin A Deficiency with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07140783Phase 3Opus Genetics, IncOPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Decreased Mesopic Visual Acuity | 2027-08 |
| NCT07736768University of Mississippi Medical CenterVitamin A Supplementation and Breast Milk Vitamin A Levels in Mothers of Preterm Infants | 2027-07-30 |
| NCT03011541MD Stem CellsStem Cell Ophthalmology Treatment Study II | 2027-07-31 |
| NCT06450925Children's Hospital Medical Center, CincinnatiVitamin A Supplementation in Allogeneic Stem Cell Transplantation. | 2027-08 |
Add all 4 to your calendar (.ics) → With an account.
Among the 16 studies in Vitamin A Deficiency with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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 early in infancy and during the second year of life, and explore the association of the gut microbiota with vaccine response. Mothers of study infants will participate in the study because the breast milk oligosaccharide content strongly affects gut microbiota composition and the "secretor status" of the mother, which can be determined from maternal FUT2 genotype, strongly affects breast milk oligosaccharide content.
Hypotheses and Specific Aims The investigators will test the hypotheses that VAS at birth will (1) improve production of new T cells at 1-2 yr of age; (2) improve T-cell memory responses at 1-2 yr of age to vaccines given early in infancy (birth - 14 wk); and (3) alter intestinal colonization early in infancy (6, 11 and 15 wk) and at 1-2 yr of age to increase Bifidobacterium and other healthy bacteria and decrease Proteobacteria and other harmful bacteria. Because the "secretor status" of the mother affects the carbohydrate content of the breastmilk, which can in turn affect Bifidobacterium growth in the infant gut, the "secretor status" of the mother will be determined. Furthermore these differences in composition of the intestinal bacteria will be associated with greater immunologic responses to oral and systemic vaccines.
Specific Aim 1: Determine if VAS or placebo at birth affect the blood concentration and thymic output of naïve T-cells at 1-2 yr of age. Specific Aim 2: Determine if VAS or placebo at birth affect T-cell mediated responses at 1-2 yr of age to vaccines given early in infancy, including serum and intestinal antibody levels, vaccine-specific proliferative responses by T cells and cytokine production by T cells. Specific Aim 3: Determine if VAS or placebo at birth affect the relative abundance of healthy intestinal bacteria and common harmful bacteria in the feces at 6, 11, and 15 wk of age and at 1-2 yr of age and determine if relative abundance of these bacteria correlates with vaccine responses shortly after vaccination (6, 11, 15 wk) and later in infancy (1-2 yr). As part of Aim 3 the "secretor status" genotype (FUT2 gene) of the mother will be determined from a cheek swab DNA sample.
The present study will recruit infants who completed NCT01583972 when they are from 12 to 24 months of age. Mothers of these infants will also be recruited for collection of DNA from a cheek swab.
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Exclusion Criteria:
Naïve T-cells in peripheral blood
The concentration of naïve T-cells in peripheral blood will be measured once at 52 - 104 wk of age by flow cytometric analysis.
Time frame: measured once at 52 - 104 weeks of age
Thymic output of naïve T cells
The thymic output of naïve T cells will be measured once at 52 - 104 wk of age by T-cell receptor excision circle (TREC) levels in DNA purified from peripheral blood mononuclear cells (PBMC).
Time frame: measured once at 52 - 104 weeks of age
Immune response to vaccines
The immune responses to vaccines, measured at 52 - 104 wk of age, include: (A) Serum immunoglobulin G (IgG) and immunoglobulin A (IgA) responses to oral polio virus vaccine (OPV; given at birth, 6 wk, 10 wk, 14 wk); (B) serum IgG response to tetanus toxoid vaccine (TT; given at 6, 10 and 14 wk) and (C) Hepatitis B virus vaccine (HBV; given at 6, 10 and 14 wk); (D) the IgA response to OPV in stool; the (E) proliferative and (F) cytokine response of peripheral blood cluster of differentiation 4 (CD4) T-cells to OPV, TT, HBV vaccines and to the tuberculosis vaccine (BCG; given at birth). Antibody responses will be measured by ELISA, T-cell proliferation by flow cytometric analysis after 6 days of culture with corresponding vaccine antigens, and cytokines will be measured in supernatant after 3 and 6 d of culture with the same antigens.
Time frame: Measured once at 52 - 104 weeks of age
Change in the relative abundance of stool bacteria
The relative abundance of stool bacteria will be measured using DNA extracts at four time points (6, 10 and 14 wk, and at one point between 52 and 104 wk) using culture-independent, next generation sequencing (NGS) of bacterial populations, followed by quantitative PCR (QPCR) and Bifidobacterium-specific terminal restriction-fragment-length polymorphism (TRFLP.)
Time frame: 6, 10, 14 and 52-104 weeks of age
Serum Vitamin A status
Vitamin A status will be assessed by serum retinol or retinol binding protein (RBP4) at 52 - 104 wk of age.
Time frame: measured once at 52-104 weeks of age
Secretor status of the study infant's mother.
The "secretor status" of the mother is determined by the FUT2 genotype. FUT2 is related to FUT1, the gene encoding fucosyltransferase 1, which determines the composition of specific glycans on erythrocytes that determine the ABO (or ABH) and Lewis blood group antigens. The activity of fucosyltransferase 2 (encoded by FUT2) causes the synthesis and secretion of these same glycans into breast milk and other secretions (e.g., saliva and other intestinal secretions).
Time frame: measured once when infant is 52 - 104 weeks of age
The record gives a start of Oct 2014, a primary completion of Sep 2015 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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USDA, Western Human Nutrition Research Center