Mineral-Enriched Powder for Iron Deficiency

Recruiting in Palo Alto (17 mi)

Overseen by Bénédicte Fontaine-Bisson, RD, PhD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Carleton University

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

Disqualifiers: Pregnancy, Anemia, Gastrointestinal disorders, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests if a special powder with added iron and zinc can improve blood iron levels in women with low iron. Participants will take the powder daily for several months to see if it helps.

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.

What data supports the effectiveness of the treatment Mineral-Enriched Powder for Iron Deficiency?

Research shows that powders containing iron and other micronutrients, like zinc, can help prevent nutritional anemia (a condition where you don't have enough healthy red blood cells due to lack of iron) in children. Additionally, studies indicate that iron supplements, such as ferrous sulfate, are effective in increasing body iron levels, which suggests that the mineral-enriched powder could be beneficial for iron deficiency. ^{1 2 3 4 5}

Is the mineral-enriched powder safe for humans?

The mineral-enriched powder, which includes iron and zinc, is generally considered safe for humans when used in food fortification. High iron concentrations can affect zinc absorption, but this is not a concern when taken with meals. The US FDA lists several iron and zinc compounds as generally recognized as safe (GRAS) for food fortification. ^{1 3 4 6 7}

How does the mineral-enriched powder treatment for iron deficiency differ from other treatments?

The mineral-enriched powder treatment is unique because it combines ferrous iron and zinc sulfate, which may help address both iron and zinc deficiencies simultaneously. Unlike some other iron supplements, this powder form can be mixed with food, potentially improving compliance and reducing gastrointestinal side effects often associated with iron pills. ^{1 3 4 6 8}

Research Team

Kristin Connor, PhD

Principal Investigator

Carleton University

Bénédicte Fontaine-Bisson, RD, PhD

Principal Investigator

University of Ottawa

Eligibility Criteria

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

I am a woman.

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

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.

Trial Timeline

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)

Treatment Details

Interventions

• Mineral-enriched powder (Other)
• Placebo powder (Other)

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.

Participant Groups

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+

Dr. Pardeep Nijhawan

University of Ottawa

Chief Medical Officer since 2022

MD from the University of Ottawa

Dr. Erich Mohr

University of Ottawa

Chief Executive Officer since 2015

PhD in Neuropsychology from the University of Victoria

Findings from Research

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]

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]

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 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]

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]

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]

References

1. England 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. [2022]

2. Switzerland 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Iron and zinc interactions in humans. [2018]

4. United States 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Electrolytic iron or ferrous sulfate increase body iron in women with moderate to low iron stores. [2023]

6. United States 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. [2022]

7. United States 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

A Mössbauer and X-ray powder diffraction study of some ferrous hematinics. [2019]