View clinical trials related to Zinc Deficiency.
Filter by:Introduction: The prevalence of low serum zinc in children under 5 in East Seme, Kisumu is 73.5% and this is likely due at least in part to low bioavailable zinc from the local cereal-based diet. Interventions that will increase zinc intake could prove useful in the effort to control zinc deficiency. A potential strategy is to increase zinc intake through enriched or fortified water. The Life Straw Family filter (LSF, Verstergaard Frandsen S.A, Switzerland) is capable of purifying water and at the same time enriching it with zinc at a variable concentration with mean delivery of approximately 1-4mg/L. Aims of the study: The primary aim of this study will be to quantify in under 5 year old children the contribution of the household LSF device to zinc intake and dietary zinc bioavailability in participating households. Secondary objectives are; 1) to assess change in serum zinc levels, growth, morbidity in the intervention group compared to control; 2) to characterize composition of the intestinal flora of children in the intervention group compared to control. Study Design and Methods: Consenting households from East Seme, Kisumu, Kenya will be randomly allocated to 2 treatment arms in an effectiveness study (90 under-five's per treatment arm). Group one will receive the LSF device with the zinc delivery system; group 2 will receive a LSF without the zinc delivery system. Zinc intake will be assessed in a subsample of the under 5 year old children enrolled in the effectiveness trial (n=100). This will be estimated by 24 hr recalls administered on 2 non-consecutive days in the dry and wet season. Selected food samples will be collected for direct analysis of zinc and phytic acid content, to supplement data from food composition tables (FCT's). The dietary assessment data will be used to estimate the distribution of zinc intakes in this age group and the EAR cut-off method will be used to estimate the proportion at risk of inadequate intakes. Data on water intake from the LSF device will be obtained by personal diaries and tally counters. The Zn concentration of the filtered water will be measured weekly. Using these data and the data from the dietary assessment, the contribution of the LSF zinc delivery to the overall dietary zinc intake will be estimated. The effectiveness study will be conducted as a 6-month double blind randomised trial with 3 assessment time points (baseline, midpoint and endpoint). Three ml (3ml) whole blood will be collected from under 5 year old children enrolled in the households for determination of serum zinc (SZn), C-reactive protein (CRP), Alpha-1- acid glycoprotein (AGP) and hemoglobin (Hb). Stool samples will be collected from a subsample at baseline, midpoint and endpoint in the intervention and control group to assess the composition of the gut microflora and gut inflammation. Anthropometrics (weight and height) will be measured at baseline, midpoint and endpoint of the study. Weekly active surveillance for incidence and severity of malaria, diarrhea and other infectious diseases will be done by questionnaire.
Children with chronic kidney disease, even after transplantation, may be at risk for bone problems due to an imbalance of calcium and phosphorus in the blood, especially as their kidneys progressively fail to function. While some drug and diet treatments are available to prevent such bone disease, many children refuse to take them due to bad taste and tummy cramps. If calcium and phosphorus status remain abnormal for a long time, hard crystals can form in the blood vessels, eventually clogging them and resulting in heart problems. Investigators are studying possible new methods to help the kidneys maintain a normal balance of nutrients in the blood which is important for growing healthy bones and the prevention of side effects in blood vessels that can lead to heart disease. One method is to improve the team work of a hormone FGF-23 and a protein called Klotho that together stimulate the kidneys to increase phosphate removal. Investigators propose that this problem may be due to low blood zinc levels which often occur in children with kidney disease. Thus, in this study, investigators propose to first measure zinc in blood from children with chronic kidney disease (CKD) or who have had kidney transplants to assess zinc and phosphate status, the hormone FGF-23 and its assistant Klotho. If zinc status is low, the children will receive zinc supplementation for 3 months. After treatment with zinc, the same blood measurements will be repeated to determine if the zinc supplements have helped the hormones to remove phosphate from the body. If this pilot project is successful, investigators will then consider a larger scale project involving adult patients as well as pediatric patients from other pediatric centers. This project will also guide investigators as to whether they need to introduce zinc measurements as part of routine testing of CKD and transplant patients. In addition to measuring zinc levels in study participants, trace elements (TE) will also be measured. These include heavy metals such as cadmium, chromium, nickel, vanadium, copper, lead, manganese and selenium. Very little is known about levels and metabolism of TE in CKD especially before dialysis. In adults, cadmium, chromium, nickel, and vanadium probably accumulate in hemodialysis patients, while copper and lead may accumulate. Manganese, selenium are probably deficient. The study will allow investigators to obtain the information about TE in this group of pediatric patients.
The general objective of this study is to determine the effect of the daily consumption of zinc-fortified water provided by the LSF-filter on zinc status and diarrhea rates in school age children from rural areas characterized by a high risk of zinc deficiency and by elevated stunting prevalence.
Study part 1 and 2 Assessment of Zn absorption from regular and biofortified wheat: stable isotope absorption studies in women of childbearing age consuming test meals prepared from either the biofortified Zn wheat, regular wheat or post-harvest fortified wheat at two different extraction rates. Study part 3 Assessment of Zn absorption from intrinsically and extrinsically labeled wheat: stable isotope absorption studies in women of childbearing age, or men, consuming test meals prepared from either intrinsically labeled Zn biofortified wheat, regular wheat or post-harvest fortified wheat extrinsically labeled immediately before consumption.
The overall aim of this trial is to determine whether the use of the household-based water treatment device Life Straw Family (LSF) can be an effective strategy to improve zinc status and health status of vulnerable populations in developing country rural settings with poor access to potable water. To assess the effectiveness of the LSF strategy (a filter delivering purified and zinc enriched water) a double blind controlled field efficacy trial will take place over a period of 12 months in rural villages in the district of Natitingou, North-West Benin. In order to attain the research objectives the efficacy trial will envisage 3 arms: intervention (zinc enriching filter), placebo (filter) and control group (disinfection tables). During the trial the following outcomes will be monitored: zinc status and growth rate of the participating children, zinc status and pregnancy outcome in a sub-sample of pregnant women (pregnancy sub-study), diarrhea prevalence in all participating subjects, water quality, zinc enrichment of water, and modality and consistency of use of the LSF-device by the study population. The study hypotheses are: 1) the use of the LSF-device will reduce microbiological contamination of the household water, 2) the use of the LSF-device will increase zinc intakes and serum zinc concentration in preschool children, 3) the use of the LSF-device will increase zinc intakes and serum zinc concentration in pregnant women, 4) the achievement of 1 and 2 will improve growth and lower frequency and length of diarrhea episodes in participating preschool children, 5) the achievement of 1 and 3 will improve pregnancy outcome and lower frequency and length of diarrhea episodes in participating pregnant women, 6) the use of the LSF-device will lower frequency and length of diarrhea episodes in participating households members.
The specific aim of this protocol is to examine differential expression of specific mRNAs and proteins that occur when the dietary intake of zinc is acutely reduced below the dietary requirement for a period of ten days.
Zinc deficiency is a widespread public health problem in developing countries. The true prevalence of this condition remains uncertain because of lack of a specific, sensitive and reliable biomarker for assessment of human zinc status. The most widely used indicator for measuring zinc status is serum zinc level, which, however, is homeostatically regulated and influenced by stress and infection. To explore the possibility of using mRNA levels of zinc responsive genes as an indicator of zinc status, Cao and Cousins suggested metallothionein (MT) mRNA level in monocytes and peripheral blood mononuclear cells as an indicator of recent zinc uptake. However, the usefulness of MT mRNA is also limited because its level is influenced by other metals, such as copper, cadmium and cobalt and it is also affected by stress. Several authors have proposed that expression of zinc transporter genes might be useful markers of Zn status. Evidence shows reduction in dietary zinc content produces a marked increase in intestinal absorption and decrease in intestinal zinc losses. As zinc homeostasis is regulated in the intestine, study of the zinc transporters in this organ may provide indication of recent zinc uptake. Recently, a few studies have begun to investigate the applicability of using white blood cell zinc transporter expression as an indicator of zinc status and found that some of the transporters are zinc responsive. The primary objective of this study is to explore whether the expression of zinc responsive genes, such as zinc transporters in human intestinal mucosal cells, can be used as indicators of zinc status. The specific aims are to compare gene expression in: a) intestinal mucosal cells obtained by duodenal biopsy, b) sloughed intestinal mucosal cells isolated from feces, and c) peripheral blood mononuclear cells (PBMC) in fasting individuals who are receiving their usual diet + placebo or their usual diet + supplemental zinc (20 mg/d for 7 days). Gene expression values from intestinal mucosal cells (biopsy) will be compared between the placebo and zinc supplemented groups. Similar comparison will be done in the cells isolated from stool and PBMCs. This study will also provide an opportunity to compare the relative responsiveness of gene expression and serum zinc concentration following supplementation and to explore the kinetics of any changes in serum zinc concentration. Thus, blood samples will be obtained for measuring serum zinc concentration on two occasions prior to the interventions and at specified intervals during and after the intervention.
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.
The study aims to compare the effects of two different formulations of zinc supplements on plasma zinc concentrations among young Burkinabe children.
The purpose of the study is to evaluate the use of plasma zinc concentration for assessing the impact of mass zinc fortification programs.