View clinical trials related to Micronutrient Deficiencies.
Filter by:This micronutrient supplementation study is a 3-arm randomized controlled trial, unblinded, with 125 women per arm. Non-pregnant, non-lactating healthy women of reproductive age in West Kiang, The Gambia, will be randomized to 12 weeks of daily supplementation of either a) novel micronutrient supplement, b) a United Nations International Multiple Micronutrient Preparation (UNIMMAP) tablet or c) no intervention (control). The novel micronutrient supplement is a drink powder providing 800 µg folic acid, 5.2 µg cyanocobalamin (B12), 2.8 mg Riboflavin-5'-phosphate (B2), and 4g trimethylglycine (betaine). UNIMMAP contains 15 micronutrients at the Recommended Daily Allowance level. The aim is to test the effectiveness of the supplements on correcting micronutrient deficiencies in the dry season and to reduce homocysteine levels. The hypothesis is that the new drink powder will be the most effective supplement, causing a reduction in 1 µmol/L compared to the control group after supplementation. The supplements will be supplied to participants on a daily basis by Community-based Birth Attendants (CBCs). The CBCs will observe consumption of the supplement. The novel micronutrient supplement will be provided in powder form with instructions to dissolve one sachet in a cup of 200ml water. UNIMMAP will be provided in capsule form to be taken with water. Women will provide one 10ml fasted venous blood sample at baseline and another after 6 and 12 weeks of supplementation. At each time point they will also have their blood pressure and anthropometry assessed and provide a urine pregnancy test. Correcting micronutrient deficiencies is extremely important for the long-term health of women, and in particular around the time of conception and throughout pregnancy since micronutrients are needed for the proper physical and cognitive development of the baby. Certain micronutrients are required for adding a methyl group to places on DNA ('DNA methylation'). The pattern of these methyl groups can help determine whether a gene is switched on or off. Correct functioning of DNA methylation processes is therefore of critical importance for fetal development. High levels of homocysteine can impede DNA methylation, therefore supplements that reduce homocysteine may not only be beneficial for the mother but also for the developing child. The most effective supplement in this trial will be considered for testing in larger pregnancy trials.
The investigators propose to study the effects of increased iron intake by home fortification of complementary foods on the gastrointestinal microbial development, inflammatory responses, and zinc (Zn) absorption. The proposed subjects are 9 month olds living in a malaria endemic area of rural Kenya who are randomized at 6 months of age to one of three fortificant groups: 1) Sprinkles™ with 12mg Iron(Fe)/day + other micronutrients, including 5mg/d Zn (test); Sprinkles™ with 0 mg/d Fe + other micronutrients, including 5mg/d Zn (control); Sprinkles™ with no micronutrients (placebo). The investigators hypothesize that the microbiome will be significantly different in the three groups and that Zn absorption and status, in addition to immune and oxidant status will be improved in the non-Fe fortified groups when compared to the Fe-fortified group.