Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT05990166
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 \<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-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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT05990166
Study Brief:
Protocol Section:
NCT05990166