View clinical trials related to Folate Deficiency.
Filter by:The overarching objective of this two-phase project is to assess the effects of fortifying iodized salt with folic acid on improving women's folate status. Folate insufficiency is the primary risk factor for neural tube defects (NTDs), which are highly prevalent in Ethiopia. The purposes of Phase 2 of the project, described herein, are to complete a community-based, randomized, dose-response intervention trial of edible salt fortified with just iodine or iodine and one of two levels of folic acid among non-pregnant women of reproductive age (WRA), We will assess the effects of the intervention on women's discretionary salt intakes, markers of folate and iodine status, and incidence of any adverse events.
Folic acid and vitamin B12 play an interdependent role in key cellular processes, namely deoxyribonucleic acid synthesis, cell division, red blood cell formation, and nervous system myelination. A deficiency of either vitamin will predispose teenagers to many diseases, which persist across their lifespan. Fortification of food with micronutrients has been promoted to reduce micronutrient deficiencies. A large segment of vulnerable populations in low- and middle-income countries (LMICs) resides in rural settings and has limited access to large-scale commercialized fortified foods. In such operational constraints, the use of locally (small-scale) fortified cereals could be an alternative intervention. The study aims to evaluate the effectiveness of small scale folic acid and vitamin B12 fortified cereals in improving folate and vitamin B12 status, growth velocity, puberty status, anaemia, cognitive development and mental health among teenage girls, in rural rift valley of Ethiopia.
The overarching objective of this two-phase project is to assess the effects of fortifying iodized salt with folic acid on improving women's folate status and thereby reduce the risk of neural tube defects (NTDs), which are highly prevalent in Ethiopia. The project will be conducted in two phases. The purpose of Phase 1, described herein, is to complete formative research in preparation for a community-based, randomized trial, which will be carried out in Phase 2. The objectives of Phase 1 are to: 1) assess the hematological condition and nutritional status with respect to folate, iodine, and other micronutrients among non-pregnant women of reproductive age (WRA) in the study communities, and 2) measure discretionary salt and dietary folate intakes of the women and their households.
New research suggests that about 1 in 8 children may be diagnosed with an autism spectrum disorder (ASD) in the United States. This could be due to several reasons which remain unknown. This study invites mothers who have given birth to children in the United States to share their experiences with diet and supplementation during pregnancy. The purpose of this study is to understand the role of a mother's diet, social standing, and supplementation with folate or folic acid may have on her child's future development of autism. Comparisons will be made between mothers of children who have a child with an official ASD diagnosis from a clinician to mothers of children without an ASD diagnosis. Findings from this study can be used to help identify risk factors for ASD risk.
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.
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
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.
This study will determine how folate supplementation affects both serum and red blood cell folate status in females ages 18 -24 years old. Additionally, this study will determine the effect of folate supplementation on mood, cognition, and sleep patterns. This study will fill a crucial gap in understanding how folate status affects a variety of health behaviors in order to better inform public health practice and prevention.
Women of reproductive age are a high-risk population for anaemia and micronutrient deficiencies. Evidence supports the role of periconceptional nutrition in the development of adverse pregnancy complications. However, in India, there are limited population-based data to guide evidence-based recommendations and priority setting. The objective of this study is to conduct a population-based biomarker survey of anaemia and vitamin B12 and folate status in women of reproductive age as part of a periconceptional surveillance program in Southern India.
Women of reproductive age are at an increased risk of anemia and micronutrient deficiencies. Evidence supports the role of periconceptional nutrition in the development of neural tube defects and other pregnancy complications. Vitamin B12 deficiency is a risk factor for neural tube defects and may modify folate biomarkers that predict neural tube defect risk at the population level. There is an interest in mandatory fortification with vitamin B12 and folic acid for anemia and birth defect prevention. However, there are limited population-representative data needed to inform policy and guidelines. This randomized trial will be conducted to evaluate the efficacy of quadruple-fortified salt (QFS; iron, iodine, folic acid, vitamin B12) in 1,000 women and their households in Southern India.