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

Launched by CARLETON UNIVERSITY · Aug 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a mineral-enriched powder can help improve iron levels in women who have low iron (iron deficiency) or a related condition called iron deficiency anemia. The trial will involve women aged 18 to 35 who are not pregnant or breastfeeding, speak English, and live in the Ottawa area. If you're eligible, you would drink the mineral-enriched powder mixed with water every day for six months and compare its effects to a placebo (a powder that looks the same but has no active ingredients).

Throughout the trial, you would need to keep a study diary, provide monthly blood samples, attend three in-person visits, and complete some questionnaires and dietary assessments. This trial is currently recruiting participants, and it aims to find out if the mineral-enriched powder can effectively increase iron levels in the blood and reduce the number of women still experiencing iron deficiency after six months. If you’re interested, make sure you meet the eligibility criteria and are willing to follow the study requirements.

Gender

FEMALE

Eligibility 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.