Mineral-enriched powder to improve iron levels in women
Randomised Controlled Trial to Assess the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age
PHASE2 · Carleton University · NCT05990166
This study is testing if a special mineral powder can help women of childbearing age with low iron levels feel better after taking it daily for six months.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Carleton University (other) |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT05990166 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a mineral-enriched powder in increasing blood iron levels in reproductive-aged women suffering from iron deficiency. Participants will consume either the mineral-enriched powder or a placebo daily for six months, while providing monthly blood samples and completing bi-weekly online diaries. The study will assess the change in iron levels and the prevalence of iron deficiency after the intervention period. The trial is designed to provide insights into the potential benefits of iron fortification in this demographic.
Who should consider this trial
Good fit: Ideal candidates for this study are non-pregnant, non-lactating women aged 18-35 who are experiencing iron deficiency.
Not a fit: Patients who are pregnant, lactating, or planning to become pregnant during the study will not benefit from this intervention.
Why it matters
Potential benefit: If successful, this study could provide an effective nutritional intervention to combat iron deficiency in women of reproductive age.
How similar studies have performed: Previous studies have shown positive outcomes with similar iron fortification approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ottawa, Ontario
- Carleton University — Ottawa, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Kristin Connor, PhD — Carleton University
- Study coordinator: Kristin Connor, PhD
- Email: kristin.connor@carleton.ca
- Phone: 613-520-2600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Iron Deficiency, Iron Deficiency Anaemia, Iron deficiency, Iron deficiency anaemia, Iron fortification, Reproductive-aged women