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

Sponsor

Carleton University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05990166

Collaborator

University of Ottawa (Other), Hopital Montfort (Other), Lucky Iron Fish Enterprise (Other)

130

Enrollment

Location

Arms

12.2

Anticipated Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Iron Deficiency Iron Deficiency Anaemia	Other: Mineral-enriched powder Other: Placebo powder	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double-blind randomised placebo-controlled trialDouble-blind randomised placebo-controlled trial

Masking:

Double (Participant, Investigator)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 27, 2023

Anticipated Primary Completion Date :

Apr 2, 2024

Anticipated Study Completion Date :

May 2, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active intervention Mineral-enriched powder	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
Placebo Comparator: Placebo Placebo powder	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)

Arm

Intervention/Treatment

Experimental: Active intervention

Mineral-enriched powder

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

Placebo Comparator: Placebo

Placebo powder

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)

Outcome Measures

Primary Outcome Measures

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. [Six months]
SF concentrations will be measured using standard clinical lab assay.

Secondary Outcome Measures

Change in SF concentrations from enrolment (baseline), to midline (three months), and endline (six months). [Baseline, three months, six months]
SF concentrations will be measured using standard clinical lab assay.
Change in haemoglobin (Hb) concentrations from enrolment (baseline), to midline (three months), and endline (six months). [Baseline, three months, six months]
Hb concentrations will be measured using standard clinical lab assay.
Levels of metabolites (circulating metabolome) at baseline, three months, and six months. [Baseline, three months, six months]
Functional metabolites in plasma will be measured by Liquid Chromatography-Mass Spectrometry (LC-MS) and Inductively Coupled Plasma-Mass Spectrometry (ICP-MS).
Concentrations of key circulating pro-inflammatory biomarkers at baseline, three months, and six months. [Baseline, three months, 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.
Dietary recall: proportion of participants meeting dietary reference intakes at baseline, three months, and six months. [Baseline, three months, 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.
Dietary recall: dietary patterns at baseline, three months, and six months. [Baseline, three months, six months]
Mean food and nutrient intakes will be used to determine dietary patterns of foods known to alter iron absorption.
Dietary recall: Healthy Eating Index (HEI) at baseline, three months, and six months. [Baseline, three months, six months]
Mean food and nutrient intakes will be used to determine HEI scores.
Dietary recall: Dietary Inflammatory Index (DII) at baseline, three months, and six months. [Baseline, three months, six months]
Mean food and nutrient intakes will be used to determine DII scores.
Self-reported perceptions of health at baseline and six months. [Baseline, 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.
Feasibility: Adherence to the consumption regimen for the regular use of the powder. [Bi-weekly through study completion, approximately 7 months]
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.
Feasibility: Adherence to the consumption regimen for the regular use of the powder at three months and six months. [Baseline, three months, 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.
Feasibility: Self-reported barriers to use of the powder. [Six months]
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.
Palatability. [Six months]
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.
Economic: Overall health status. [Six months]
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.
Economic: Health state/health state index. [Six months]
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.
Economic: Quality adjusted life years (QALYs). [Six months]
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.
Safety (adverse events/harms). [Baseline, three months, six months, and seven months]
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.

Other Outcome Measures

Exploratory: Microbial metagenome. [Baseline, three months, six months]
The gut microbial metagenome at baseline, three months, and six months. Bacterial genomic DNA will be isolated from stool samples and analysed by whole genome sequencing. Outcomes will be reported descriptively in placebo and intervention groups for: relative abundance, diversity, and variance.
20. Exploratory: Microbial metagenome inferred function. [Baseline, three months, six months]
Exploratory analyses of inferred function of the metagenome at baseline, three months, and six months. Compositional approaches and Ingenuity Pathway Analysis will be used to generate hypotheses of genes, networks and biological pathways and processes that may be inﬂuenced by the intervention, accounting for clinical data.
Exploratory: Microbial metabolome. [Baseline, three months, six months]
The gut metabolome at baseline, three months, and six months. Microbial metabolome will be measured in placebo and intervention groups and data related to computationally-derived functions from metagenome data) using Liquid Chromatography-Mass Spectrometry (LC-MS) and Inductively Coupled Plasma-Mass Spectrometry (ICP-MS). Data will be processed under standard pipelines with visualisation and pathway analysis by Agilent Mass Proﬁler, MetaboAnalyst and KEGG databases.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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 </=20 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 >20 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.