CompletedPhase 2

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

Canada150 participantsStarted 2023-04-27

Plain-language 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)

Who can participate

Age range18 Years – 35 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

What they're measuring

Serum ferritin (SF) concentrations between active intervention and placebo groups at endline (six months). Proportion of participants remaining iron deficient between active intervention and placebo groups at six months.

Timeframe: Six months

Trial details

NCT IDNCT05990166

SponsorCarleton University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-12