Status:
ACTIVE_NOT_RECRUITING
Assessing the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age
Lead Sponsor:
Carleton University
Collaborating Sponsors:
University of Ottawa
Hopital Montfort
Conditions:
Iron Deficiency
Iron Deficiency Anaemia
Eligibility:
FEMALE
18-35 years
Phase:
PHASE2
Brief 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 q...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05990166
Start Date
April 27 2023
End Date
May 30 2026
Last Update
October 6 2025
Active Locations (1)
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1
Carleton University
Ottawa, Ontario, Canada, K1S 5B6