Assessing the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age
Iron Deficiency, Iron Deficiency Anaemia
About this trial
This is an interventional treatment trial for Iron Deficiency focused on measuring Iron deficiency, Iron deficiency anaemia, Iron fortification, Reproductive-aged women
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 </=20 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 <12 μg/L or >20 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.
Sites / Locations
- Carleton UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Active intervention
Placebo
Mineral-enriched powder
Placebo powder