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

Last updated: June 4, 2024
Sponsor: Carleton University
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Mineral-enriched powder

Placebo powder

Clinical Study ID

NCT05990166
LIFE2022RCT2
  • Ages 18-35
  • Female

Study 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)

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

Total Participants: 130
Treatment Group(s): 2
Primary Treatment: Mineral-enriched powder
Phase: 2
Study Start date:
April 27, 2023
Estimated Completion Date:
September 19, 2025

Connect with a study center

  • Carleton University

    Ottawa, Ontario K1S 5B6
    Canada

    Active - Recruiting

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