Phase
Condition
N/ATreatment
Mineral-enriched powder
Placebo powder
Clinical Study ID
Ages 18-35 Female
Study Summary
Eligibility Criteria
Inclusion
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 poorconsensus 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 thisstudy
Able to understand and read the questionnaires in English and carry out allstudy-related procedures
Located in the greater Ottawa area and a resident of Ontario
Exclusion
Exclusion Criteria:
Individuals who are lactating, pregnant, or planning to become pregnant during thestudy
Individuals who are not maintaining adequate birth control measures
Adequate birth control measures include any option that will adequately preventpregnancy including: contraceptives, lifestyle choices, complete abstinence, oras a result of other medical methods, procedures, or conditions
Have a known sensitivity, intolerability, or allergy to any of the study products ortheir excipients
Are using vitamin and mineral supplements containing iron and/or zinc
SF concentrations <12 μg/L or >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-patientintervention program)
Use of investigational product(s) in another research study within 30 days prior tothe 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'sdisease
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 Willebranddisease)
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 ofmedications/supplements/ therapies that according to the scientific literature, mayadversely affect the participant's ability to complete the study or its measures orpose a significant risk to the participant or the quality of the study data.
Study Design
Connect with a study center
Carleton University
Ottawa, Ontario K1S 5B6
CanadaActive - Recruiting
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