Assessing the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age
NCT ID: NCT05990166
Last Updated: 2025-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2023-04-27
2026-05-30
Brief Summary
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* 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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active intervention
Mineral-enriched powder
Mineral-enriched powder
Mineral-enriched powder Mineral-enriched powder to allow for at-home fortification of beverages with 5 mg of ferrous iron and 10 mg of zinc sulfate monohydrate
Placebo
Placebo powder
Placebo powder
Placebo powder which is identical to the mineral- enriched powder, but does not contain the active ingredients (ferrous iron and zinc sulfate monohydrate)
Interventions
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Mineral-enriched powder
Mineral-enriched powder Mineral-enriched powder to allow for at-home fortification of beverages with 5 mg of ferrous iron and 10 mg of zinc sulfate monohydrate
Placebo powder
Placebo powder which is identical to the mineral- enriched powder, but does not contain the active ingredients (ferrous iron and zinc sulfate monohydrate)
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
35 Years
FEMALE
No
Sponsors
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University of Ottawa
OTHER
Hopital Montfort
OTHER
Lucky Iron Fish Enterprise
UNKNOWN
Carleton University
OTHER
Responsible Party
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Kristin Connor, PhD
Associate Professor
Principal Investigators
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Kristin Connor, PhD
Role: PRINCIPAL_INVESTIGATOR
Carleton University
Bénédicte Fontaine-Bisson, RD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Ottawa
Locations
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Carleton University
Ottawa, Ontario, Canada
Countries
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References
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Subar AF, Kirkpatrick SI, Mittl B, Zimmerman TP, Thompson FE, Bingley C, Willis G, Islam NG, Baranowski T, McNutt S, Potischman N. The Automated Self-Administered 24-hour dietary recall (ASA24): a resource for researchers, clinicians, and educators from the National Cancer Institute. J Acad Nutr Diet. 2012 Aug;112(8):1134-7. doi: 10.1016/j.jand.2012.04.016. Epub 2012 Jun 15. No abstract available.
Bansback N, Tsuchiya A, Brazier J, Anis A. Canadian valuation of EQ-5D health states: preliminary value set and considerations for future valuation studies. PLoS One. 2012;7(2):e31115. doi: 10.1371/journal.pone.0031115. Epub 2012 Feb 6.
Devlin N, Parkin D, Janssen B. Methods for Analysing and Reporting EQ-5D Data [Internet]. Cham (CH): Springer; 2020. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK565678/
Gloor GB, Hummelen R, Macklaim JM, Dickson RJ, Fernandes AD, MacPhee R, Reid G. Microbiome profiling by illumina sequencing of combinatorial sequence-tagged PCR products. PLoS One. 2010 Oct 26;5(10):e15406. doi: 10.1371/journal.pone.0015406.
Gloor GB, Wu JR, Pawlowsky-Glahn V, Egozcue JJ. It's all relative: analyzing microbiome data as compositions. Ann Epidemiol. 2016 May;26(5):322-9. doi: 10.1016/j.annepidem.2016.03.003. Epub 2016 Apr 2.
Fernandes AD, Reid JN, Macklaim JM, McMurrough TA, Edgell DR, Gloor GB. Unifying the analysis of high-throughput sequencing datasets: characterizing RNA-seq, 16S rRNA gene sequencing and selective growth experiments by compositional data analysis. Microbiome. 2014 May 5;2:15. doi: 10.1186/2049-2618-2-15. eCollection 2014.
Zierer J, Jackson MA, Kastenmuller G, Mangino M, Long T, Telenti A, Mohney RP, Small KS, Bell JT, Steves CJ, Valdes AM, Spector TD, Menni C. The fecal metabolome as a functional readout of the gut microbiome. Nat Genet. 2018 Jun;50(6):790-795. doi: 10.1038/s41588-018-0135-7. Epub 2018 May 28.
Abdel Rahman AM, Pawling J, Ryczko M, Caudy AA, Dennis JW. Targeted metabolomics in cultured cells and tissues by mass spectrometry: method development and validation. Anal Chim Acta. 2014 Oct 3;845:53-61. doi: 10.1016/j.aca.2014.06.012. Epub 2014 Jun 12.
Other Identifiers
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LIFE2022RCT2
Identifier Type: -
Identifier Source: org_study_id
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