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Night Blindness clinical trials

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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: 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.

NCT ID: NCT01061307 Completed - Iron Deficiency Clinical Trials

An Efficacy Trial of Iron, Zinc and Vitamin A Fortified Rice in Children in Satun, Thailand

Start date: September 2009
Phase: Phase 0
Study type: Interventional

Iron, zinc and vitamin A deficiencies are particularly common among children and young women in the developing countries of South and Southeast Asia resulting in important adverse health effects. Simultaneous fortification of rice with iron, zinc and vitamin A could be a novel and sustainable approach to control these deficiencies. Recently conducted extrusion trials have demonstrated that extruded rice grains containing iron, zinc and vitamin A show acceptable stability during production and storage and good sensory properties. The grains were produced using a twin-screw extruder equipped with a special cutter and a rice shaping die. The Fe, Zn and vitamin A content of the extruded product is 10 mg, 9 mg and 1050 μg per g of rice, respectively. In this study the investigators plan to test the efficacy of the extruded triple fortified rice in Satun, Thailand, an area where rice is the staple food. Preliminary data from this area show that zinc and vitamin A intakes are low. Biochemical indicators have confirmed zinc deficiency and suboptimal vitamin A status in 1/3 of school aged children. The efficacy of the fortified rice will be evaluated in a 9 months, controlled, double-blind intervention trial in 7-12 y-old children. Children will be selected from primary schools in Satun Province based on low serum zinc values as the primary goal is to investigate Zn efficacy. As secondary outcome the effect on iron and vitamin A status will be investigated. The children will be randomized into two groups: a control group will receive a daily non-fortified rice lunch meal at school, while the second group will receive a daily rice meal containing the triple fortified rice. The rice meals will be given 5 days a week. At baseline, weight and height will be measured and determination of hemoglobin, serum ferritin, zinc protoporphyrin, serum zinc, serum retinol and C-reactive protein will be done. At mid-point and at 9 months, the baseline measurements will be repeated to judge the efficacy of the triple fortified rice.

NCT ID: NCT00742937 Completed - Clinical trials for Vitamin A Deficiency

Impact of Maternal Supplementation With Dual Megadose of Vitamin A

Start date: July 2007
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of maternal supplementation with 400,000 IU of oral retinol palmitate in the post-partum, the nutritional situation of the binomial mother-child, on growth and morbidity of children in breastfeeding in the first six months of life.

NCT ID: NCT00680212 Completed - Clinical trials for Vitamin A Deficiency

Vitamin A Equivalence of Plant Carotenoids in Children

Start date: July 2008
Phase: Phase 2
Study type: Interventional

Our objectives will be to test the following hypotheses and to make the following determinations: (1) The absorption and bio-conversion of provitamin A carotenes taken by children are different between spinach, Golden Rice, and ß-C in oil capsules. (2) The absorption of provitamin A carotenes and their bioconversion to vitamin A are different in children with or without adequate vitamin A nutrition. (3) To define the vitamin A equivalence(s) of dietary spinach, Golden Rice, and a ß-C in oil dose by using an isotope reference method in children with or without adequate vitamin A nutrition and to compare those values with values derived from model based compartmental analysis. (4) To determine the number and time of blood samples needed for future studies in various field settings on the retinol equivalence of a large number of plant sources.

NCT ID: NCT00674089 Completed - Clinical trials for Vitamin A Deficiency

Newborn Vitamin A (VA) Supplementation Pilot Project, Pakistan

VA
Start date: January 2007
Phase: N/A
Study type: Interventional

Vitamin A is an essential micronutrient for the normal functioning of the visual system, growth and development, immunity and reproduction. Its deficiency causes anemia, growth retardation and xerophthalmia. Vitamin A deficiency also increases the incidence and/or severity of infectious episodes and affects child survival. Reduced child survival is the most severe and potentially the most widespread consequence of Vitamin A deficiency. Improvement in vitamin A status is now regarded as one of the most cost effective preventive measures for the reduction of child mortality and morbidity. Over the past decade several studies have examined the effect of vitamin A on reducing mortality among children aged ≥6months at the time of intervention. Impact of vitamin A supplementation can significantly reduce total mortality but it is only established through supplementation programs in children age 6 months or older. It was assumed that breast milk protects infants from vitamin A deficiency, but recent evidence has challenged this. Infants born with low stores of vitamin A and if the mother breast milk has a low concentration of vitamin A, as found in developing countries, the infants might be unable to meet their daily requirements and improve body reserves. There is association between mortality and degree of vitamin A deficiency, greater the degree of deficiency, higher the mortality. The role of vitamin A in child survival is now well established and over 60 countries have vitamin A supplementation programs nationally. However, most are still using vitamin A supplements in the second half of infancy, even though over 75% of all under 5 deaths take place in the first 6 months of life. If neonatal vitamin A supplementation can be found to be effective and a service delivery mechanism also found, this will represent a major advance in reaching the MDG 4 targets. This is thus persuasive reason to explore this particular preventive strategy, especially in terms of packaging with other postnatal care activities. However, given that in some instances it has been difficult to disentangle the effect of vitamin A dosing from concomitant vaccinations such as BCG, the current evidence needs further evaluation in effectiveness settings. We propose to evaluate the effectiveness of early neonatal vitamin A administration (single dose 50,000 units) to the newborn to see its effect on infant mortality less than 6 months of age as part of postnatal package through National Program. Government has launched the National Program for Family Planning and Primary Health Care since April 1994. Primarily it is being implemented in the community through Lady Health Workers (LHWs) of the National Program. The LHWs are females, with a minimum of eight years of education, residents of the locality in which they are working. The Programme is being currently implemented in all the districts throughout the country and 93,000 LHWs are working covering primarily women and children of the rural population. These LHWs deliver services related to family planning, maternal and child health, immunization, nutrition and treatment of minor ailments to her average registered population of 100-150 households or ~1000 population. Over 3,000 Supervisors have been recruited and trained to supervise the work of LHWs.

NCT ID: NCT00569023 Completed - Night Blindness Clinical Trials

Treatment of Congenital Stationary Night Blindness With an Alga Containing High Dose of Beta Carotene

Start date: July 2007
Phase: N/A
Study type: Interventional

To assess the effect of oral administration of the alga Dunaliella bardawil containing approximately 50% all-trans beta-carotene and 50% 9-cis beta-carotene isomers on visual functions patients with Congenital Stationary Night Blindness {Fundus albipunctatus).