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Assessing the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age
Sponsor: Carleton University
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)
Official title: Randomised Controlled Trial to Assess the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age
Key Details
Gender
FEMALE
Age Range
18 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2023-04-27
Completion Date
2026-05-30
Last Updated
2025-10-06
Healthy Volunteers
No
Conditions
Interventions
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)
Locations (1)
Carleton University
Ottawa, Ontario, Canada