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

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

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)

Sponsors & Collaborators

• University of Ottawa

  collaborator OTHER

• Hopital Montfort

  collaborator OTHER

• Lucky Iron Fish Enterprise

  collaborator UNKNOWN

• Carleton University

  lead OTHER

Principal Investigators

• Kristin Connor, PhD · Carleton University

• Bénédicte Fontaine-Bisson, RD, PhD · University of Ottawa

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-27

Primary Completion

2026-03-12

Completion

2026-03-25

Countries

• Canada

Study Locations