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

Carleton University

Status and phase: Enrolling; Phase 2

Conditions: Iron Deficiency; Iron Deficiency Anaemia

Treatments: Other: Placebo powder; Other: Mineral-enriched powder

Study type: Interventional

Funder types: Other

Identifiers

NCT05990166

LIFE2022RCT2

Details and patient eligibility

About

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)

Enrollment: 130 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups, including a placebo group

Active intervention

Experimental group

Description:

Mineral-enriched powder

Treatment:

Other: Mineral-enriched powder

Placebo

Placebo Comparator group

Description:

Placebo powder

Treatment:

Other: Placebo powder