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NCT05990166 | RECRUITING | Iron Deficiency

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

Carleton University

Information provided by (Responsible Party):

Kristin Connor, PhD

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 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)

Condition or disease

Iron Deficiency

Iron Deficiency Anaemia

Intervention/treatment

Mineral-enriched powder

Placebo powder

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 130 participants
Masking : DOUBLE
Masking Description : All participants, researchers, and the study physician will be blinded to the treatment group (active intervention or placebo) to which participants have been randomised. A delegated unblinded staff member will be permitted to unblind participants for safety purposes, if requested by the principal investigators or the study physician.
Primary Purpose : TREATMENT
Official Title : Randomised Controlled Trial to Assess the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age
Actual Study Start Date : 2023-04-27
Estimated Primary Completion Date : 2025-08-19
Estimated Study Completion Date : 2025-09-19

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 35 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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 \
  • * 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.
Assessing the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age

Location Details

NCT05990166

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Locations

RECRUITING

Canada, Ontario

Carleton University

Ottawa, Ontario, Canada, K1s 5b6