Mineral-Enriched Powder for Iron Deficiency

Overseen By Bénédicte Fontaine-Bisson, RD, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Carleton University

Must not be taking: Antacids, NSAIDs, Antivirals, others

Disqualifiers: Pregnancy, Anemia, Gastrointestinal disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a mineral-enriched powder (containing ferrous iron and zinc sulphate monohydrate) can increase blood iron levels in women with low iron. Participants will take the powder daily for six months and will be compared to those taking a placebo (a look-alike powder with no active ingredients). This trial suits women experiencing iron deficiency who are not currently taking iron or zinc supplements. Participants must commit to regular online check-ins, blood samples, and a few in-person visits in the Ottawa area. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications, such as antacids, aspirin, and any drugs that interact with iron supplements. If you are using vitamin or mineral supplements containing iron or zinc, you will also need to stop those.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that the mineral-enriched powder, containing iron and zinc, is generally safe when added to food. Previous studies have found that people usually tolerate these powders well. Although high iron levels can sometimes cause stomach upset, this rarely occurs if the powder is used as directed.

Participants in earlier trials reported very few side effects, indicating the powder's safety for daily use. The combination of iron and zinc often helps with iron deficiency and has not shown any serious safety issues. Overall, this mineral-enriched powder has demonstrated a strong safety record in studies with similar goals. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for iron deficiency?

Unlike the standard of care for iron deficiency, which often involves oral iron supplements or intravenous iron, the mineral-enriched powder offers a unique delivery method that could improve absorption and reduce side effects. Researchers are excited because this powder may provide a gentler alternative for individuals who struggle with the gastrointestinal issues typically associated with traditional iron supplements. Additionally, its formulation could allow for more flexibility in dosing and potentially enhance compliance among patients.

What evidence suggests that this mineral-enriched powder could be effective for iron deficiency?

In this trial, participants will receive either a mineral-enriched powder or a placebo powder. Research has shown that the mineral-enriched powder, which contains added minerals like iron and zinc, might help increase iron levels in the blood. This treatment targets common shortages of iron and zinc, which can cause tiredness and weakness. People who used similar powders previously saw improvements in their blood iron levels. The mix of iron and zinc in the powder is designed to enhance the body's absorption and use of these minerals. Early results suggest this method could help reduce iron deficiency in women of childbearing age. ^{1 2 3 4 6}

Who Is on the Research Team?

Kristin Connor, PhD

Principal Investigator

Carleton University

Bénédicte Fontaine-Bisson, RD, PhD

Principal Investigator

University of Ottawa

Are You a Good Fit for This Trial?

This trial is for English-speaking women aged 18-35 in the Ottawa area who are not pregnant or lactating, have iron levels indicating deficiency but not severe anemia, and can commit to study procedures. Excluded are those planning pregnancy, changing diet/exercise soon, with certain medical conditions or taking conflicting medications.

Inclusion Criteria

Non-pregnant and non-lactating

Able to understand and read the questionnaires in English and carry out all study-related procedures

I am a woman.

Exclusion Criteria

Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients

I am scheduled for surgery during this study.

I am currently taking medications like antacids, aspirin, steroids, blood thinners, or thyroid medicine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a mineral-enriched powder or placebo daily for six months

6 months

3 visits (in-person), monthly blood samples, bi-weekly online diary entries

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mineral-enriched powder
• Placebo powder

Trial Overview The study tests if a daily mineral-enriched powder increases blood iron levels over six months compared to a placebo. Participants will drink the powder mixed with water, keep an online diary, provide monthly blood samples, attend three visits for assessments and sample collections.

How Is the Trial Designed?

Group I: Active intervention Experimental Treatment 1 Intervention

Mineral-enriched powder

Group II: Placebo Placebo Group 1 Intervention

Placebo powder

Who Is Running the Clinical Trial?

Carleton University

Lead Sponsor

Trials

3

Recruited

170+

Lucky Iron Fish Enterprise

Collaborator

Trials

1

Recruited

130+

Hopital Montfort

Collaborator

Trials

15

Recruited

5,000+

University of Ottawa

Collaborator

Trials

231

Recruited

267,000+

Published Research Related to This Trial

Fortifying cereal flours with iron is an effective public health strategy to combat iron deficiency, with soluble iron compounds like ferrous sulfate being more easily absorbed than elemental iron powders.

Among the various elemental iron powders evaluated, only electrolytic iron powder is recommended for fortification, but it should be used in double the amount compared to ferrous sulfate due to its lower absorption rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The usefulness of elemental iron for cereal flour fortification: a SUSTAIN Task Force report. Sharing United States Technology to Aid in the Improvement of Nutrition. Hurrell, R., Bothwell, T., Cook, JD., et al.[2022]

The study found that the bioavailability of six commercial elemental iron powders is significantly lower than that of bakery-grade ferrous sulfate, with a maximum difference of up to three times, indicating that not all iron supplements are equally effective.

Factors such as solubility at pH 1.0 and surface area of the iron powders were strong predictors of their bioavailability, suggesting that these physicochemical properties should be considered when evaluating iron supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioavailability of elemental iron powders to rats is less than bakery-grade ferrous sulfate and predicted by iron solubility and particle surface area. Swain, JH., Newman, SM., Hunt, JR.[2022]

Ferrous salts, specifically ferrous fumarate, gluconate, and sulfate, are commonly used and well-tolerated oral treatments for iron deficiency anemia, which is a frequent health issue.

Mössbauer spectroscopy and X-ray powder diffraction techniques were used to analyze these ferrous salts, revealing that ferrous fumarate and gluconate contain about 10% ferric iron, and providing the first reported Mössbauer spectrum for ferrous fumarate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mössbauer and X-ray powder diffraction study of some ferrous hematinics. Coe, EM., Bowen, LH., Bereman, RD.[2019]

In a study involving young children in Dhaka, Bangladesh, daily dispersible zinc tablets significantly increased serum zinc levels to 92.5 μg/dL, outperforming most other interventions except for the high-zinc, low-iron micronutrient powders.

Both the standard and high-zinc micronutrient powders effectively improved iron status without negatively affecting zinc levels, indicating that these interventions can be safely combined in addressing deficiencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Different Doses, Forms, and Frequencies of Zinc Supplementation on Biomarkers of Iron and Zinc Status among Young Children in Dhaka, Bangladesh. Islam, MM., Black, RE., Krebs, NF., et al.[2022]

In a study involving 51 women over 12 weeks, FeSO4 and electrolytic iron significantly improved body iron levels compared to placebo, while heme and reduced iron did not show significant efficacy.

Electrolytic iron was found to be about 86% as effective as FeSO4 in increasing body iron, suggesting it could be a viable alternative for improving iron status in women with low iron stores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrolytic iron or ferrous sulfate increase body iron in women with moderate to low iron stores. Swain, JH., Johnson, LK., Hunt, JR.[2023]

Micronutrient powders significantly reduce the risk of iron-deficiency anemia in children, with odds ratios of 0.20 for powders without zinc and 0.25 for those with zinc, based on a trial involving 2746 children in Pakistan.

However, the use of these powders was associated with an increased incidence of diarrhoea and respiratory issues, indicating that while they can improve iron levels, careful consideration of potential side effects is necessary in populations with high rates of malnutrition and diarrhoea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of provision of daily zinc and iron with several micronutrients on growth and morbidity among young children in Pakistan: a cluster-randomised trial. Soofi, S., Cousens, S., Iqbal, SP., et al.[2022]

Iron deficiency is the most common nutritional deficiency globally, and while high iron concentrations can negatively affect zinc absorption in adults, this effect is not observed when iron and zinc are consumed as part of a meal.

Recent studies indicate that fortifying foods with iron at current levels does not adversely affect zinc absorption, suggesting that dietary strategies for increasing iron and zinc intake can be safely implemented without compromising zinc levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iron and zinc interactions in humans. Whittaker, P.[2018]

In a study involving 101 women, the combination of phytase and NaFeEDTA significantly enhanced iron absorption from fortified porridge, achieving an absorption rate of 7.4%, compared to just 1.5% with FeSO4 without enhancers.

This optimization strategy for low-iron micronutrient powders could enable safer and more effective in-home fortification of complementary foods, increasing iron bioavailability without the risks associated with high iron doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimization of a phytase-containing micronutrient powder with low amounts of highly bioavailable iron for in-home fortification of complementary foods. Troesch, B., Egli, I., Zeder, C., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05990166

Assessing the Effect of a Mineral-enriched Powder on Iron ... 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 ...

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/488235

Assessing the Effect of a Mineral-enriched Powder on Iron ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10750016/

Sensory evaluations of a novel iron and zinc‐enriched powder ... Our results provide important insight into the sensory qualities of a novel formulation of an iron and zinc‐enriched powder for at‐home fortification and ...

4. withpower.com withpower.com/trial/phase-2-anemia-iron-deficiency-3-2023-8903d

Mineral-Enriched Powder for Iron Deficiency The mineral-enriched powder treatment is unique because it combines ferrous iron and zinc sulfate, which may help address both iron and zinc deficiencies ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/mcn.13575

Sensory evaluations of a novel iron and zinc‐enriched ... We aimed to determine the palatability and acceptability of a novel iron and zinc-enriched powder fortified in tap water by conducting sensory evaluations.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0002916522035845

A community-based randomized controlled trial of iron and ... Deficiencies of iron and zinc often coexist and cause growth faltering (1), delayed development (2), and increased morbidity due to infectious disease (3) that ...