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

Carleton University2 sites in 1 country150 target enrollmentApril 27, 2023

ConditionsIron Deficiency Iron Deficiency Anaemia

InterventionsMineral-enriched powder Placebo powder

Overview

Phase: Phase 2
Intervention: Mineral-enriched powder
Conditions: Iron Deficiency
Sponsor: Carleton University
Enrollment: 150
Locations: 2
Primary Endpoint: 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.
Status: Completed
Last Updated: 5 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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)

Registry

clinicaltrials.gov

Start Date

April 27, 2023

End Date

March 25, 2026

Last Updated

5 days ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Carleton University

Responsible Party

Principal Investigator

Kristin Connor, PhD

Associate Professor

Carleton University

Eligibility Criteria

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 \\/\=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

Arms & Interventions

Active intervention

Mineral-enriched powder

Intervention: Mineral-enriched powder

Placebo

Placebo powder

Intervention: Placebo powder

Outcomes

Primary Outcomes

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.

Time Frame: Six months

SF concentrations will be measured using standard clinical lab assay.

Secondary Outcomes

Change in SF concentrations from enrolment (baseline), to midline (three months), and endline (six months).(Baseline, three months, six months)
Levels of metabolites (circulating metabolome) at baseline, three months, and six months.(Baseline, three months, six months)
Dietary recall: Healthy Eating Index (HEI) at baseline, three months, and six months.(Baseline, three months, six months)
Change in haemoglobin (Hb) concentrations from enrolment (baseline), to midline (three months), and endline (six months).(Baseline, three months, six months)
Concentrations of key circulating pro-inflammatory biomarkers at baseline, three months, and six months.(Baseline, three months, six months)
Dietary recall: proportion of participants meeting dietary reference intakes at baseline, three months, and six months.(Baseline, three months, six months)
Dietary recall: dietary patterns at baseline, three months, and six months.(Baseline, three months, six months)
Dietary recall: Dietary Inflammatory Index (DII) at baseline, three months, and six months.(Baseline, three months, six months)
Self-reported perceptions of health at baseline and six months.(Baseline, six months)
Feasibility: Adherence to the consumption regimen for the regular use of the powder.(Bi-weekly through study completion, approximately 7 months)
Feasibility: Adherence to the consumption regimen for the regular use of the powder at three months and six months.(Baseline, three months, six months)
Feasibility: Self-reported barriers to use of the powder.(Six months)
Palatability.(Six months)
Economic: Overall health status.(Six months)
Economic: Health state/health state index.(Six months)
Economic: Quality adjusted life years (QALYs).(Six months)
Safety (adverse events/harms).(Baseline, three months, six months, and seven months)