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

NCT05990166 | Completed Phase 2

• 1 other identifier: LIFE2022RCT2
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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)

Conditions

Iron Deficiency; Iron Deficiency Anaemia

Keywords

Iron deficiency; Iron deficiency anaemia; Iron fortification; Reproductive-aged women

Outcome Measures

Primary Outcomes (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.

  Six months

Secondary Outcomes (17)

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

• Levels of metabolites (circulating metabolome) at baseline, three months, and 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

Other Outcomes (3)

• Exploratory: Microbial metagenome.

  Baseline, three months, six months

• Exploratory: Microbial metagenome inferred function.

  Baseline, three months, six months

• Exploratory: Microbial metabolome.

  Baseline, three months, six months

Study Arms (2)

Active intervention

EXPERIMENTAL

Mineral-enriched powder

Other: Mineral-enriched powder

Placebo

PLACEBO COMPARATOR

Placebo powder

Other: Placebo powder

Interventions

Mineral-enriched powder OTHER

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

Active intervention

Placebo powder OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Non-pregnant and non-lactating
• English speaking with the ability to give informed consent
• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Carleton University: lead
• University of Ottawa: collaborator
• Hopital Montfort: collaborator
• Lucky Iron Fish Enterprise: collaborator

Study Sites (1)

Carleton University

Ottawa, Ontario, K1S 5B6, Canada

Location

Related Publications (8)

• 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.

  PMID: 22704899 BACKGROUND

• 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.

  PMID: 22328929 BACKGROUND

• 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/

  PMID: 33347096 BACKGROUND

• 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.

  PMID: 21048977 BACKGROUND

• 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.

  PMID: 27143475 BACKGROUND

• 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.

  PMID: 24910773 BACKGROUND

• 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.

  PMID: 29808030 BACKGROUND

• 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.

  PMID: 25201272 BACKGROUND

MeSH Terms

Conditions

Iron Deficiencies; Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Kristin Connor, PhD

  Carleton University

  PRINCIPAL INVESTIGATOR

• Bénédicte Fontaine-Bisson, RD, PhD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All participants, researchers, and the study physician will be blinded to the treatment group (active intervention or placebo) to which participants have been randomised. A delegated unblinded staff member will be permitted to unblind participants for safety purposes, if requested by the principal investigators or the study physician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Double-blind randomised placebo-controlled trial

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: August 14, 2023
• Study Start: April 27, 2023
• Primary Completion: March 12, 2026
• Study Completion: March 25, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)