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Assessing the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age

Iron Deficiency | Iron Deficiency Anaemia

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)

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Participation Requirements

  • Sex:

    FEMALE
  • Eligible Ages:

    18 to 35

Participation 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.

Study Location

Carleton University
Carleton University
Ottawa, Ontario
Canada

Contact Study Team

Backup Contact

Bénédicte Fontaine-Bisson, RD, PhD

[email protected]
613-562-5800
Primary Contact

Kristin Connor, PhD

[email protected]
613-520-2600
Study Sponsored By
Carleton University
Participants Required
More Information
Study ID: NCT05990166