AzTrials
AzTrials

Iron DeficiencyPhase 2NCT05990166

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

A Phase 2 study testing Mineral-enriched powder in people with Iron Deficiency and Iron Deficiency Anaemia, run by Carleton University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, women only
Conditions the study is for
Iron Deficiency, Iron Deficiency Anaemia
What is being tested?
Mineral-enriched powder
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteCanada
Study dates
27 Apr 2023to 25 Mar 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 39Show fewer
  • 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
  • Donate blood more than two to three times per year
  • Had major surgery in the past three months
  • Have planned surgery during the course of the study
  • History of problematic alcohol or substance use in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program)
  • Use of investigational product(s) in another research study within 30 days prior to the baseline visit or during the study duration
  • Using any of the following drugs:
  • Antacids or proton pump inhibitors, H2 blockers
  • Salicylates, aspirin, corticosteroids, nonsteroidal anti-inflammatory drugs
  • Anticoagulants, antiplatelet compounds
  • Drugs with known contraindication with iron supplementation or fortification
  • Antiviral medications
  • Levothyroxine (Synthroid)
  • Known medical history of specific conditions including:
  • Gastrointestinal disorders: celiac disease, ulcerative colitis, and Crohn's disease
  • Gastric cancer and gastric polyps
  • Colon cancer
  • Diverticular bleeding
  • Inflammatory bowel diseases
  • Angiodysplasia
  • Helicobacter pylori infection
  • Hookworm (Ancylostoma duodenale and Necator americanus)
  • Defects of hemostasis (hereditary hemorrhagic telangectasia, von Willebrand disease)
  • Gastrectomy, duodenal bypass, bariatric surgery
  • Erythropoiesis-stimulating agent therapy
  • Chronic kidney disease
  • Hemochromatosis
  • Hemoglobinopathies
  • Blood clotting disorder
  • Have any other active or unstable medical conditions or use of medications/supplements/ therapies that according to the scientific literature, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant or the quality of the study data.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Carleton University

    Ottawa, Ontario, K1S 5B6

Other trials in Canada

About this study

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

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?
Read more

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)
Being tested
Mineral-enriched powder, Placebo powder
Keywords
Iron deficiency, Iron deficiency anaemia, Iron fortification, Reproductive-aged women
Medical subject headings
Iron Deficiencies, Anemia, Iron-Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mineral-enriched powderOther

    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

  • Placebo powderOther

    Placebo powder which is identical to the mineral- enriched powder, but does not contain the active ingredients (ferrous iron and zinc sulfate monohydrate)

Study groups in NCT05990166
Study groupRoleWhat they receive
Active interventionExperimentalMineral-enriched powder
Receives: Other: Mineral-enriched powder
PlaceboPlacebo comparatorPlacebo powder
Receives: Other: Placebo powder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    SF concentrations will be measured using standard clinical lab assay.

    Measured: Six months

Secondary outcomes (17)

  1. Change in SF concentrations from enrolment (baseline), to midline (three months), and endline (six months).

    SF concentrations will be measured using standard clinical lab assay.

    Measured: Baseline, three months, six months

  2. Change in haemoglobin (Hb) concentrations from enrolment (baseline), to midline (three months), and endline (six months).

    Hb concentrations will be measured using standard clinical lab assay.

    Measured: Baseline, three months, six months

  3. Levels of metabolites (circulating metabolome) at baseline, three months, and six months.

    Functional metabolites in plasma will be measured by Liquid Chromatography-Mass Spectrometry (LC-MS) and Inductively Coupled Plasma-Mass Spectrometry (ICP-MS).

    Measured: Baseline, three months, six months

  4. Concentrations of key circulating pro-inflammatory biomarkers at baseline, three months, and six months.

    Plasma pro-inflammatory biomarkers will be measured using standard protocols via multi-plex assay (Human Cytokine 27-plex Assay, BioRad) which includes biomarkers such as TNF-alpha, IL-6, MCP-1. The assay will be conducted, and biomarkers measured according to manufacturer's guidelines.

    Measured: Baseline, three months, six months

  5. Dietary recall: proportion of participants meeting dietary reference intakes at baseline, three months, and six months.

    Mean food and nutrient intakes will be used to determine proportion of participants meeting dietary reference intakes. Dietary recalls will be conducted using the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) Canada 2018. This tool measures all food and beverages consumed over a 24-hour period. Dietary recalls will be considered complete if participants provide a minimum of two days of 24-hour recall.

    Measured: Baseline, three months, six months

  6. Dietary recall: dietary patterns at baseline, three months, and six months.

    Mean food and nutrient intakes will be used to determine dietary patterns of foods known to alter iron absorption.

    Measured: Baseline, three months, six months

  7. Dietary recall: Healthy Eating Index (HEI) at baseline, three months, and six months.

    Mean food and nutrient intakes will be used to determine HEI scores.

    Measured: Baseline, three months, six months

  8. Dietary recall: Dietary Inflammatory Index (DII) at baseline, three months, and six months.

    Mean food and nutrient intakes will be used to determine DII scores.

    Measured: Baseline, three months, six months

  9. Self-reported perceptions of health at baseline and six months.

    Proportion of participants reporting overall good health status will be measured at baseline and at six months. A descriptive health profile will be generated based on health dimensions in both the active intervention and placebo groups. Number of patients, proportions of categorical responses for each health dimensions, including the severity of the health concern will be derived. The investigators will explore significance of change in health profile within each group and significance of the difference between the active intervention and placebo groups at six months. The investigators will assess associations of health profile with adherence to study regimen.

    Measured: Baseline, six months

  10. Feasibility: Adherence to the consumption regimen for the regular use of the powder.

    Proportion of participants with >80% adherence (defined as preparation and consumption of the powder on at least 4 days per week or a minimum of every second day for the duration of the trial) will be measured bi-weekly for the duration of the trial. Adherence will be determined using the study diary, in which participants will report which days they consumed the study product and which days they did not. Adherence will be reported by participants bi-weekly for the duration of the study.

    Measured: Bi-weekly through study completion, approximately 7 months

  11. Feasibility: Adherence to the consumption regimen for the regular use of the powder at three months and six months.

    Proportion of unused powder sachets will be measured at three and six months. Participants will be asked to return all used (opened) and unused (unopened) powder sachets at three months and six months. Proportion of unused sachets will be calculated.

    Measured: Baseline, three months, six months

  12. Feasibility: Self-reported barriers to use of the powder.

    Proportion of participants reporting perceived barriers to use of the study product at six months. Qualitative summary of types of perceived barriers at six months.

    Measured: Six months

  13. Palatability.

    Palatability (i.e. odour, colour, and taste assessments) collected at six months. Palatability assessments of the study product will be conducted at six months using a 9-point hedonic scale to generate palatability scores (where >/=5 indicates that the solution was liked). Differences in participant palatability scores (for colour, odour, sweet, sour, bitter, salty, umami and overall liking) and proportion of participants willing to drink the sample daily will be used to assess the palatability of the powder, show whether the powder is accepted by consumers, and document relationships between palatability and adherence.

    Measured: Six months

  14. Economic: Overall health status.

    Overall health status will be measured by the EuroQol-5D visual analogue scale (EQ-5D VAS) at six months. The EQ-5D VAS provides a score of 0 to 100, where 0 represents the worst imaginable health status and 100 represents the best imaginable health status.

    Measured: Six months

  15. Economic: Health state/health state index.

    Health state values will be measure by EuroQol-5D (EQ-5D) at six months. Health state values will be used to generate health state index score using Canadian valuation of EQ-5D health states.

    Measured: Six months

  16. Economic: Quality adjusted life years (QALYs).

    Health state index scores derived from the EuroQol-5D (EQ-5D) at six months will be used to calculate quality-adjusted life years (QALYs), which will be used to perform cost effectiveness analysis.

    Measured: Six months

  17. Safety (adverse events/harms).

    Proportion of adverse events (AEs) and proportion of withdrawals from the study due to harms will be measured at baseline, three months, six months, and approximately seven months (four weeks post study end). AE/harms monitoring will occur bi-weekly for the duration of the study and up to four weeks after last study visit for unresolved AEs.

    Measured: Baseline, three months, six months, and seven months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start27 Apr 2023
  3. Primary completion12 Mar 2026
  4. Study completion25 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double-blind randomised placebo-controlled trial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05990166
Sponsor's protocol ID
LIFE2022RCT2
Status last verified
Apr 2026
First submitted
26 May 2023
Last updated
27 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Subar AF, Kirkpatrick SI, Mittl B, Zimmerman TP, Thompson FE, Bingley C, Willis G, Islam NG, Baranowski T, McNutt S, Potischman N. The Automated Self-Administered 24-hour dietary recall (ASA24): a resource for researchers, clinicians, and educators from the National Cancer Institute. J Acad Nutr Diet. 2012 Aug;112(8):1134-7. doi: 10.1016/j.jand.2012.04.016. Epub 2012 Jun 15. No abstract available.

    PubMed 22704899

  • Bansback N, Tsuchiya A, Brazier J, Anis A. Canadian valuation of EQ-5D health states: preliminary value set and considerations for future valuation studies. PLoS One. 2012;7(2):e31115. doi: 10.1371/journal.pone.0031115. Epub 2012 Feb 6.

    PubMed 22328929

  • Devlin N, Parkin D, Janssen B. Methods for Analysing and Reporting EQ-5D Data [Internet]. Cham (CH): Springer; 2020. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK565678/

    PubMed 33347096

  • Gloor GB, Hummelen R, Macklaim JM, Dickson RJ, Fernandes AD, MacPhee R, Reid G. Microbiome profiling by illumina sequencing of combinatorial sequence-tagged PCR products. PLoS One. 2010 Oct 26;5(10):e15406. doi: 10.1371/journal.pone.0015406.

    PubMed 21048977

  • Gloor GB, Wu JR, Pawlowsky-Glahn V, Egozcue JJ. It's all relative: analyzing microbiome data as compositions. Ann Epidemiol. 2016 May;26(5):322-9. doi: 10.1016/j.annepidem.2016.03.003. Epub 2016 Apr 2.

    PubMed 27143475

  • Fernandes AD, Reid JN, Macklaim JM, McMurrough TA, Edgell DR, Gloor GB. Unifying the analysis of high-throughput sequencing datasets: characterizing RNA-seq, 16S rRNA gene sequencing and selective growth experiments by compositional data analysis. Microbiome. 2014 May 5;2:15. doi: 10.1186/2049-2618-2-15. eCollection 2014.

    PubMed 24910773

  • Zierer J, Jackson MA, Kastenmuller G, Mangino M, Long T, Telenti A, Mohney RP, Small KS, Bell JT, Steves CJ, Valdes AM, Spector TD, Menni C. The fecal metabolome as a functional readout of the gut microbiome. Nat Genet. 2018 Jun;50(6):790-795. doi: 10.1038/s41588-018-0135-7. Epub 2018 May 28.

    PubMed 29808030

  • Abdel Rahman AM, Pawling J, Ryczko M, Caudy AA, Dennis JW. Targeted metabolomics in cultured cells and tissues by mass spectrometry: method development and validation. Anal Chim Acta. 2014 Oct 3;845:53-61. doi: 10.1016/j.aca.2014.06.012. Epub 2014 Jun 12.

    PubMed 25201272

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mineral-enriched powder in people with Iron Deficiency and Iron Deficiency Anaemia, run by Carleton University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05990166, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in