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Vitamin A Deficiency clinical trials

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NCT ID: NCT05178407 Active, not recruiting - Anemia Clinical Trials

Effect of Household Use of Multiple Micronutrient-fortified Bouillon on Micronutrient Status Among Women and Children in Two Districts in the Northern Region of Ghana

Start date: January 16, 2023
Phase: N/A
Study type: Interventional

Background: Micronutrient (MN) deficiencies are severe and widespread in West Africa, particularly among young children and women of reproductive age. Bouillon is a promising food fortification vehicle because the product is centrally processed on large scale, consumed by most households in West African countries (even rural, poor households), and consumed by most members of the household in relatively constant amounts. However, several important research questions remain regarding whether the use of fortified bouillon would be feasible and effective for preventing or reducing micronutrient deficiencies in communities where such deficiencies are common. Specifically, no studies have assessed the impacts of multiple micronutrient-fortified bouillon on micronutrient status. The West Africa Condiment Micronutrient Innovation Trial (CoMIT) Project aims to address this gap, to inform future discussions around fortification of bouillon cubes and related products. Objective: This study aims to assess the impacts of household use of multiple micronutrient-fortified bouillon cubes (containing iodine in addition to vitamin A, folic acid, vitamin B12, iron, and zinc), compared to control bouillon cubes fortified with iodine only, on: 1. Micronutrient status among women 15-49 years of age and children 2-5 years of age after 9 months of intervention 2. Hemoglobin concentrations among women 15-49 years of age and children 2-5 years of age after 9 months of intervention 3. Breast milk micronutrient concentrations among lactating women 4-18 months postpartum after 3 months of intervention Methods: This randomized, controlled doubly-masked trial will be conducted in the Kumbungu and Tolon districts in the Northern Region of Ghana, where prior data indicate that deficiencies in the selected nutrients are common. Potential participants will be: 1) non-pregnant non-lactating women of reproductive age (15 - 49 years old), 2) children 2-5 years of age, and 3) non-pregnant lactating women 4-18 months postpartum. Eligible participants will be randomly assigned to receive household rations of one of two types of bouillon cubes: 1. a multiple micronutrient-fortified bouillon cube containing vitamin A, folic acid, vitamin B12, iron, zinc, and iodine, or 2. a control cube containing iodine only Each participant's household will receive a specific amount of bouillon cube every 2 weeks, and households will be advised to prepare their meals as usual, using the study-provided cubes. The trial duration will be 9 months (38 weeks) for non-pregnant, non-lactating women and children 2-5 years of age, and 3 months (12 weeks) for lactating women. The primary outcomes will be changes from baseline to endline in concentrations of haemoglobin and biomarkers of micronutrient status. Secondary outcomes will include change in prevalence of anaemia and micronutrient deficiency; dietary intake of bouillon and micronutrients; inflammation, malaria, and morbidity symptoms; and children's anthropometric measures and child development.

NCT ID: NCT04780958 Completed - Clinical trials for Vitamin A Deficiency

Retinol Status in Preterm Infants and Mothers

Start date: June 1, 2020
Phase: N/A
Study type: Interventional

Retinol and retinol binding protein were studied in the umbilical cord blood of 44 preterm infants with gestation age of < 30 weeks. Serum retinol and RBP levels were determined by enzyme-linked immunosorbent assay. The rate of transplacental retinol passage was calculated. The demographic data of mother and baby, vitamin use in the mother, antenatal steroid application and diseases diagnosed during pregnancy were recorded. An evaluation was made of the retinol, RBP and factors of the mother and baby affecting the transplacental retinol passage. The relationship between retinol and retinol binding protein levels and neonatal mortality and morbidity was investigated.

NCT ID: NCT04694235 Recruiting - Child Development Clinical Trials

Egg Intervention During Pregnancy in Indonesia

PRECODE
Start date: February 12, 2021
Phase: N/A
Study type: Interventional

The study consists of two arms: 1) intervention group using eggs as supplementary food given from 2nd trimester of pregnancy to birth, and 2) observational group of pregnant mothers. it aims to assess the effectiveness of improving dietary quality during pregnancy on the epigenetic and stunting related outcomes (growth and development) in infants, who will be followed up until 24 months old

NCT ID: NCT04632771 Completed - Anemia Clinical Trials

Nutritional Status and Bouillon Use in Northern Ghana

Start date: October 19, 2020
Phase:
Study type: Observational

This pilot aims to generate data that are critical for informing the design of a planned, more detailed study to evaluate the effect of multiple micronutrient (MN)-fortified bouillon cube on biomarkers of nutrient status of women and children. Data collection includes measures of nutritional status and dietary intake among women and children and their households in communities in northern Ghana.

NCT ID: NCT04438200 Recruiting - Clinical trials for Vitamin A Deficiency

Liver and Bone Retinol Levels in Guatemalan Adolescents and Adults

GVAS
Start date: October 24, 2019
Phase:
Study type: Observational

Guatemala has enforced mandatory fortification of sugar with vitamin A (VA) since June 1974 and has led to a highly successful reduction in VA deficiency and associated disease. However, Ribaya-Mercado et al. 2014, estimated the biological impact of sugar fortified with retinyl palmitate that there may be a risk of chronic excess intake of preformed VA associated with programs of mass fortification. A recent food consumption survey in two departments in Guatemala found the average daily sugar intake in children under the age of two who aren´t being breastfed is 30.3 g, which translates into a daily intake of 272 μg of retinol (almost the full estimated average requirement (EAR) for that age group). Since data from the second National Survey on Micronutrients suggest a risk of VA toxicity, it is important to determine the levels of hepatic VA directly in corpses of individuals, of all ages, who have died of non-metabolic causes. Due to this, the investigators propose to assess liver and bone VA levels in combination with gene expression, histopathology and biochemical analyses, to elicit indications of hypervitaminosis A in Guatemala.

NCT ID: NCT04170348 Active, not recruiting - Asthma Clinical Trials

Daily Vitamin D for Sickle-cell Respiratory Complications

ViDAS-2
Start date: September 15, 2020
Phase: Phase 2
Study type: Interventional

This study aims to answer the question whether daily oral vitamin D supplementation can reduce the risk of respiratory or lung complications in children and adolescents with sickle cell disease. Respiratory problems are the leading causes of sickness and of death in sickle cell disease. The investigators hypothesize that daily oral vitamin D3, compared to monthly oral vitamin D, will rapidly increase circulating vitamin D3, and reduce the rate of respiratory complications by 50% or more within the first year of supplementation in children and adolescents with sickle cell disease. This study is funded by the FDA Office of Orphan Products Development (OOPD).

NCT ID: NCT04153968 Recruiting - Clinical trials for Vitamin A Deficiency

Bioefficacy of Beta-cryptoxanthin From Biofortified Maize

BIOCRYPT
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Since no quantitative information currently exists on how effectively the pro-vitamin A carotenoid (pVAC) β-cryptoxanthin (βCX) is converted to vitamin A (VA) in humans, this proof of principle study aims to compare the efficacy of both βCX and β-carotene (βC) to yield VA from biofortified maize. This data is critical before the breeding strategy for biofortified maize is directed towards high βCX-containing varieties in order to reduce VA deficiency in low-income countries.

NCT ID: NCT04137354 Completed - Clinical trials for Anemia, Iron Deficiency

Iron and Vitamin A in School Children

IronVitA
Start date: November 2, 2020
Phase: N/A
Study type: Interventional

The WHO recommended intermittent iron supplementation as a strategy for prevention of anemia and iron deficiency among school age children. Several aspects of cognitive development, co-supplementation with other micronutrients, severe adverse events especially in the context of malaria were missing. The investigators will evaluate the effectiveness of intermittent iron and vitamin A supplementation on cognitive development and anemia and iron status of Rural Ethiopian school children.

NCT ID: NCT04127968 Not yet recruiting - Sepsis Clinical Trials

Efficacy and Safety of Vitamin A Treatment for Children With Sepsis

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

The prevalence of vitamin A deficiency was found high in children with sepsis. Whether those patients will benefit from the vitamin A supplementation is unknown.

NCT ID: NCT04123210 Completed - Clinical trials for Vitamin A Deficiency

Estimating Average Vitamin A Requirements in Indonesian and American Women

Start date: March 17, 2008
Phase: N/A
Study type: Interventional

Women of reproductive age had their vitamin A stores estimated by retinol isotope dilution and then were given vitamin A supplements near the US vitamin A RDA or placebo for 42(USA) or 60 (Indonesia) days, after which retinol isotope dilution was repeated and the change in vitamin A stores was determined in each group to estimate how much vitamin A is needed to maintain nutrient balance in these women.