assessing the effect of a mineral-enriched powder on iron deficiency in women of reproductive age

Conditions: Iron Deficiency; Iron Deficiency Anaemia

Summary: the goal of this clinical trial is to determine if taking a mineral-enriched powder can raise blood iron levels compared to a placebo powder in reproductive-aged women with iron deficiency. the main questions it aims to answer are: * does the mineral-enriched powder raise blood iron levels compared to a placebo powder in women when it is taken every day for six months? * how many participants still have iron deficiency after six months of taking the mineral-enriched powder compared to a placebo powder? participants in this clinical trial will drink the mineral-enriched powder containing ferrous iron and zinc sulphate monohydrate or a placebo powder mixed with 1 litre of water daily for six months. the placebo is a look-alike substance that does not contain active ingredients (iron and zinc). participants will also have to: * complete an online "study diary" every two weeks for six months * provide a blood sample once a month for six months * attend three in-person visits with a researcher, at enrolment (baseline), midline (three months), and endline (six months) * complete three sets of online questionnaires (following each in-person visit) * complete three sets of dietary assessments (following each in-person visit) * provide three stool samples (following each in-person visit)


Eligibility criteria:
inclusion criteria: * non-pregnant and non-lactating * english speaking with the ability to give informed consent * 18-35 years of age (inclusive) * women who are biologically female * iron deficient (sf \>/=12μg/l and \</=30 μg/l). note: there is currently poor consensus on diagnostic criteria for iron deficiency based on sf concentrations. current recommendations range from 15 μg/l to 100 μg/l. * hb \>/=110 g/l * willing and able to agree to the requirements and lifestyle restrictions of this study * able to understand and read the questionnaires in english and carry out all study-related procedures * located in the greater ottawa area and a resident of ontario exclusion criteria: * individuals who are lactating, pregnant, or planning to become pregnant during the study * individuals who are not maintaining adequate birth control measures * adequate birth control measures include any option that will adequately prevent pregnancy including: contraceptives, lifestyle choices, complete abstinence, or as a result of other medical methods, procedures, or conditions * have a known sensitivity, intolerability, or allergy to any of the study products or their excipients * are using vitamin and mineral supplements containing iron and/or zinc * sf concentrations \ 30 μg/l * having moderate or severe anaemia (hb \<109 g/l) * expecting to change diet and exercise regimen in the next 6 months * are frequent blood donors * have donated blood in the last four months * donate blood more than two to three times per year * had major surgery in the past three months * have planned surgery during the course of the study * history of problematic alcohol or substance use in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program) * use of investigational product(s) in another research study within 30 days prior to the baseline visit or during the study duration * using any of the following drugs: * antacids or proton pump inhibitors, h2 blockers * salicylates, aspirin, corticosteroids, nonsteroidal anti-inflammatory drugs * anticoagulants, antiplatelet compounds * drugs with known contraindication with iron supplementation or fortification * antiviral medications * levothyroxine (synthroid) * known medical history of specific conditions including: * gastrointestinal disorders: celiac disease, ulcerative colitis, and crohn's disease * gastric cancer and gastric polyps * colon cancer * diverticular bleeding * inflammatory bowel diseases * angiodysplasia * helicobacter pylori infection * hookworm (ancylostoma duodenale and necator americanus) * defects of hemostasis (hereditary hemorrhagic telangectasia, von willebrand disease) * gastrectomy, duodenal bypass, bariatric surgery * erythropoiesis-stimulating agent therapy * chronic kidney disease * hemochromatosis * hemoglobinopathies * blood clotting disorder * have any other active or unstable medical conditions or use of medications/supplements/ therapies that according to the scientific literature, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant or the quality of the study data.

Keywords: iron deficiency iron deficiency anaemia iron fortification reproductive-aged women