Clinical trial NCT05990166: Assessing the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age
Official title: Randomised Controlled Trial to Assess the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Iron Deficiency
Iron Deficiency Anaemia
Keywords: Iron deficiency
Iron deficiency anaemia
Iron fortification
Reproductive-aged women
Lead sponsor: Carleton University
Sponsor class: OTHER
Collaborators: name: University of Ottawa
name: Hopital Montfort
name: Lucky Iron Fish Enterprise
First posted: 2023-08-14
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind randomised placebo-controlled trial
Primary purpose: TREATMENT

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)


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 \</=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

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
  * 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.

Primary outcomes:
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.
timeFrame: Six months
Secondary outcomes:
measure: Change in SF concentrations from enrolment (baseline), to midline (three months), and endline (six months).
timeFrame: Baseline, three months, six months
measure: Change in haemoglobin (Hb) concentrations from enrolment (baseline), to midline (three months), and endline (six months).
timeFrame: Baseline, three months, six months
measure: Levels of metabolites (circulating metabolome) at baseline, three months, and six months.
timeFrame: Baseline, three months, six months
measure: Concentrations of key circulating pro-inflammatory biomarkers at baseline, three months, and six months.
timeFrame: Baseline, three months, six months
measure: Dietary recall: proportion of participants meeting dietary reference intakes at baseline, three months, and six months.
timeFrame: Baseline, three months, six months
measure: Dietary recall: dietary patterns at baseline, three months, and six months.
timeFrame: Baseline, three months, six months
measure: Dietary recall: Healthy Eating Index (HEI) at baseline, three months, and six months.
timeFrame: Baseline, three months, six months
measure: Dietary recall: Dietary Inflammatory Index (DII) at baseline, three months, and six months.
timeFrame: Baseline, three months, six months
measure: Self-reported perceptions of health at baseline and six months.
timeFrame: Baseline, six months
measure: Feasibility: Adherence to the consumption regimen for the regular use of the powder.
timeFrame: Bi-weekly through study completion, approximately 7 months
measure: Feasibility: Adherence to the consumption regimen for the regular use of the powder at three months and six months.
timeFrame: Baseline, three months, six months
measure: Feasibility: Self-reported barriers to use of the powder.
timeFrame: Six months
measure: Palatability.
timeFrame: Six months
measure: Economic: Overall health status.
timeFrame: Six months
measure: Economic: Health state/health state index.
timeFrame: Six months
measure: Economic: Quality adjusted life years (QALYs).
timeFrame: Six months
measure: Safety (adverse events/harms).
timeFrame: Baseline, three months, six months, and seven months
Other outcomes:
measure: Exploratory: Microbial metagenome.
timeFrame: Baseline, three months, six months
measure: Exploratory: Microbial metagenome inferred function.
timeFrame: Baseline, three months, six months
measure: Exploratory: Microbial metabolome.
timeFrame: Baseline, three months, six months
Locations:
city: Ottawa
country: Canada
facility: Carleton University
state: Ontario
Study officials:
affiliation: Carleton University
name: Kristin Connor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ottawa
name: Bénédicte Fontaine-Bisson, RD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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/
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.