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ACTIVE NOT RECRUITING
NCT05990166
PHASE2

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

Sponsor: Carleton University

View on ClinicalTrials.gov

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

Interventions

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)

Locations (1)

Carleton University

Ottawa, Ontario, Canada