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Showing 1-9 of 9 trials
NCT02233764
In this study, iron- and zinc-biofortified pearl millet will be fed to young children in Mumbai, Maharashtra, India over a period of nine months to measure iron status, growth and immune function in comparison to children receiving non-biofortified pearl millet.
NCT05236374
The objective of the current study is to test the overarching hypothesis that the beef nutritive matrix is uniquely suited to direct dietary zinc to cellular compartments for improved metabolic function, leading to a greater effect on health outcomes. Specifically, whether beef, as a component of a healthy meal, will promote the absorption of zinc into cells, where the zinc will have greater effects on zinc-dependent metabolic processes supporting cardiovascular health. To maximize the observability of these beef-related effects, individuals who are 55- to 70-year-old who generally have a higher risk of zinc deficiency and cardiovascular disease will be enrolled.
NCT04632771
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.
NCT04559152
This experimental study was conducted with pre-test/post-test control groups and double-blind randomization from March to December 2019 at Universitas Sumatera Utara Hospital and others in Medan. Subjects were pregnant mothers in second or third trimester and with their newborns who met the inclusion criteria. Subjects were divided into two groups and administered either zinc supplementation 20 mg/day or placebo, respectively, for 12 weeks. The parameters assessed were maternal serum zinc levels cord blood osteocalcin and birth length measurements.
NCT03421314
The aim of this study is to evaluate the effect of zinc gluconate and/or selenium yeast supplementation during six months on clinical (glucose, cholesterol, triglycerides, bone mineral density and body composition) and immunological (oxidative stress, CD4+ count and pro-inflammatory cytokines) parameters in a population with HIV diagnosis on antiretroviral treatment.
NCT02668133
Background: Community based-intervention trials conducted among infants and young children in low- and middle-income countries have found that zinc supplementation of young children (in the form of liquid supplements or dispersible tablets) increases linear growth and weight gain, and reduces the prevalence of diarrhea and respiratory infections, and lowers all-cause mortality. Aside from supplements, additional dietary zinc can also be provided through "home-fortification" of complementary foods with small-quantity lipid-based nutrient supplements (SQ-LNS; 20g/d), which are typically formulated as a peanut-based paste enriched with a vitamin and mineral complex containing 8 mg elemental zinc (as ZnSO4). However, the efficacy of LNS as a delivery vehicle for preventive zinc supplementation remains uncertain. Two recent studies, which provided LNS containing 4-10 mg Zn daily for 6-9 months found no significant differences in plasma zinc concentrations at the end of the intervention period compared to placebo. This lack of response may be due to the reduced absorption of zinc when it is part of a complex food matrix and provided with cereal-based meals; both SQ-LNS and cereal grains contain moderate to high concentrations of phytate, the main dietary factor known to substantially reduce zinc absorption. The addition of exogenous phytases is an efficacious strategy to reduce the phytate content of foods, and increase the bioavailability of dietary zinc; however, the efficacy of this approach has not yet been demonstrated for SQ-LNS. Objective: The overall objective of the study is to assess the efficacy of adding exogenous phytase to SQ-LNS by investigating intra-individual differences in the fractional absorption of zinc (FAZ) among children who receive additional dietary zinc (8 mg/d) from SQ-LNS with or without phytase. Trial approach: The study will be a double-blind randomized controlled clinical trial, designed to permit within-child comparisons of zinc absorption from SQ-LNS, with or without exogenous phytase, by using the triple stable-isotope ratio tracer technique. The clinical study will enroll 34 children between the ages of 18-23 months. The main outcome of interest is the intra-individual difference in the FAZ from porridge-based meals containing SQ-LNS with and without phytase. Up to an' additional 36 children will be enrolled in a pilot feeding study to determine portion sizes of study meals. Trial setting: Keneba, The Gambia Trial interventions: The SQ-LNS (20g) used in this study will be provided by Nutriset, S.A.S. The exogenous phytase (DSM phytase Tolerase 20000G) is derived from Aspergillus niger; phytase will be added to the SQ-LNS during the production phase, and will be enzymatically active in vivo at the time of consumption. Feeding Protocol and Study Diet: The study diet for the 2day absorption study will consist of the following: 1) Two stable-isotope labeled test meals per day (porridge made from locally procured non-fermented cereal, mixed with 10 g of SQ-LNS), with children randomized to receive either SQ-LNS with phytase or SQ-LNS without phytase on the first day and the alternative product on the second; 2) One additional standardized meal per day (e.g. rice with sauce); 3) Low-zinc, low-phytate food (e.g. bananas) consumed ad libitum if requested (with the exception of 1 hour before and 2 hours after each test meal). Children will be fed by their caregivers under supervision by a study fieldworker. The SQ-LNS product (without phytase) will be provided to children twice per day for one day prior to the start of the stable isotope absorption studies, in order to habituate children to the study diet and location. Children will attend the study clinic daily for four days and will be enrolled in the study for a total of ten days. Zinc absorption studies: The FAZ of zinc will be measured by a triple-isotope tracer ratio technique, using orally administered extrinsic labels (Zn-67 and Zn-70) and intravenous Zn-68. Urine samples, collected pre- and post-isotope administration (d 1, 5-9) will be analyzed for zinc isotope ratios by ICP-MS. FAZ will be calculated based on the mean isotopic ratios obtained from the enriched urine samples, and based on the tracer:tracee ratio method. TAZ will be calculated by multiplying FAZ by total zinc intake from the test meals. Data Collection: The following information will be collected from each subject: brief medical history; physical examination; weight and height; daily morbidity and pre-intervention blood sampling for hemoglobin, complete blood count and plasma zinc concentration, malaria and systemic inflammation (C-reactive protein and α-1-acid glycoprotein).
NCT02951715
Twenty patients with tinnitus and a typical noise-induced hearing loss (NIHL) audiogram were included. Each subject underwent an otoscopic examination, distortion product otoacoustic emissions, tinnitus-match testing, Tinnitus Handicap Inventory (THI) and serum zinc level analyses. After 2 months of treatment with zinc, all tests were repeated.
NCT01472211
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.
NCT01221129
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.