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Night Blindness clinical trials

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NCT ID: NCT01922713 Completed - Clinical trials for Vitamin A Deficiency

Effect of Daily Consumption of Orange Maize on Breast Milk Retinol in Lactating Zambian Women

Start date: October 2013
Phase: N/A
Study type: Interventional

The purpose of the study is to determine whether daily consumption of beta-carotene biofortified maize will increase breast milk retinol concentration in lactating Zambian women.

NCT ID: NCT01703559 Completed - Clinical trials for Disturbance; Vision, Loss

The Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution in Subjects With Severe Night Vision Disturbances

Start date: September 9, 2011
Phase: Phase 2
Study type: Interventional

The objectives of this study are: - To evaluate the efficacy of phentolamine mesylate 0.5% and 1.0% ophthalmic solution (Nyxol) in the treatment of night vision complaints, including reduced contrast sensitivity - To evaluate the ocular and systemic safety of phentolamine mesylate 0.5% and 1.0% ophthalmic solution (Nyxol) compared to its vehicle, a sterile, isotonic, buffered aqueous solution containing mannitol and sodium acetate

NCT ID: NCT01695148 Completed - Clinical trials for Vitamin A Deficiency

Efficacy of β-carotene Biofortified Maize in Reducing Vitamin A Deficiency Among Children

Start date: August 2012
Phase: Phase 3
Study type: Interventional

The purpose of this cluster-randomized trial is to examine whether daily consumption of β-carotene biofortified maize flour can reduce the prevalence of vitamin A deficiency and improve the vitamin A status and among 4-8 year old children in rural Zambia.

NCT ID: NCT01614483 Completed - Clinical trials for Vitamin A Deficiency

Efficacy of Yellow Cassava to Improve Vitamin A Status of Kenyan School Children

CASSAVITA
Start date: May 2012
Phase: N/A
Study type: Interventional

The overall aim of the project is to provide proof-of-principle that biofortification of cassava with vitamin A is a viable strategy to improve vitamin A status of deficient populations.

NCT ID: NCT01583972 Completed - Clinical trials for Vitamin A Deficiency

Efficacy of Newborn Vitamin A Supplementation in Improving Immune Function

Start date: January 2012
Phase: N/A
Study type: Interventional

Vitamin A supplementation at birth may increase survival of infants through one year of age by reducing mortality from infectious diseases, though current studies are not conclusive on this point. The goal of our study is to determine if supplementation of newborn infants with 50,000 IU of vitamin A improves aspects of immune function that may be impaired by vitamin A deficiency. Our underlying assumption is that supplementation may thus decrease risk of death by improving immune function and the ability to survive infections. This project will be limited to the examination of the impact of vitamin A on immune function and will not aim to determine the impact on morbidity or mortality, which would require larger sample sizes. The hypotheses addressed by this study are as follows: Provision of vitamin A supplements to newborns at risk of vitamin A deficiency will (1) improve functioning of the thymus (the source of T lymphocytes, cells of the immune system that are important in response to infection and immunization); (2) enhance T lymphocyte-mediated responses to standard vaccines given at birth and early in infancy; and (3) improve gut barrier function (i.e., ability to prevent bacterial infection across the epithelial barrier), relative to provision of a placebo.

NCT ID: NCT01559766 Completed - Clinical trials for Vitamin A Deficiency

Dietary Vitamin A Requirement in Chinese Children and the New Technology of Dietary Assessment

Start date: July 2009
Phase: N/A
Study type: Observational

Vitamin A deficiency remains a major public health problem in developing country worldwide. Young Children are considered to be at greatest risk of deficiency. However, there is little information on the vitamin A requirement of Chinese children. In the present study, about 400 children aged between 4 and 9 years old in a kindergarten and an elementary school of Shiyan City were screened before admission by questionnaire and anthropometric measurement. The vitamin A status of children was assessed by serum vitamin A level, relative dosage reaction and stable-isotope dilution technique. At the same time, their dietary vitamin A intakes were estimated by weighted-food dietary survey. The dietary vitamin A requirement in young children was determined on the basis of dietary vitamin A intakes in Children with adequate vitamin A level.

NCT ID: NCT01476358 Active, not recruiting - Clinical trials for Vitamin A Deficiency

Effect of Vitamin A Supplementation on Immune Responses in Human Neonates

NNVAS
Start date: November 2011
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT01420406 Completed - Clinical trials for Vitamin A Deficiency

Vitamin A Bioavailability in Lactating Women With Marginal Vitamin A Status

Start date: June 2010
Phase: N/A
Study type: Interventional

The study will assess the relative bioavailability and bioefficacy of cryptoxanthin (CX) and beta-carotene (BC) from food sources for increasing breast milk carotenoid and retinol concentrations in lactating Bangladeshi women.

NCT ID: NCT01381276 Completed - Clinical trials for Vitamin A Deficiency

Vitamin A Absorption From Cassava in Women

FL-80
Start date: June 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the vitamin A equivalents in high-carotenoid varieties of cassava.

NCT ID: NCT01199445 Completed - Clinical trials for Vitamin A Deficiency

Efficacy of Vitamin A in Fortified Extruded Rice in School Children

Start date: August 2010
Phase: Phase 0
Study type: Interventional

The project aims to evaluate the potential impact triple fortified rice grains, mixed into natural rice grains, can have on vitamin A status if fed to school children in Southern Thailand. Within a 60 day intervention study, changes in vitamin A status in young children fed the fortified rice compared to children consuming non-fortified rice will be assessed.