NCT05990166

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

Randomised Controlled Trial to Assess the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Carleton University · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Iron Deficiency
• Iron Deficiency Anaemia

Interventions

Type	Name	Description
OTHER	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
OTHER	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)

Timeline

• Start date: 2023-04-27
• Primary completion: 2026-04-30
• Completion: 2026-05-30
• First posted: 2023-08-14
• Last updated: 2025-10-06

Locations

1 site across 1 country: Canada