What side effects are associated with this type of intervention?

Common side effects of iron supplementation, such as ferrous iron, include gastrointestinal issues like constipation, diarrhea, nausea, and abdominal pain. Zinc supplementation, such as zinc sulfate monohydrate, can also cause gastrointestinal upset, including nausea and vomiting. Additionally, high doses of zinc may interfere with copper absorption, potentially leading to copper deficiency.

What prior FDA approvals exist?

The FDA has approved several treatments for iron deficiency, primarily focusing on iron supplementation. Commonly approved oral iron supplements include ferrous sulfate, ferrous gluconate, and ferrous fumarate. These supplements are designed to increase iron levels in the blood and are often used to treat iron deficiency anemia. Additionally, intravenous iron formulations such as iron sucrose, ferric carboxymaltose, and iron dextran are available for patients who cannot tolerate oral iron or have severe deficiency. While zinc supplementation is not typically a primary treatment for iron deficiency, it is sometimes included in multivitamin and mineral supplements to support overall health.

What other types of research exist?

Promising alternatives to mineral-enriched powder for iron deficiency include: 1) Controlled-release iron tablets such as Ferrocontin Continus (ferrous glycine sulphate), which have shown good clinical efficacy and tolerance in comparative studies. 2) Sodium iron ethylenediaminetetra-acetate (NaFeEDTA), which has been effective in increasing hemoglobin and serum ferritin levels in iron-deficient populations. These alternatives may offer improved compliance and effectiveness for patients.

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Other

Mineral-Enriched Powder for Iron Deficiency

Phase 2

Recruiting

Led By Kristin Connor, PhD

Research Sponsored by Carleton University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

English speaking with the ability to give informed consent

18-35 years of age (inclusive)

Must not have

Have planned surgery during the course of the study

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, three months, six months

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of the mineral-enriched powder may include gastrointestinal discomfort or constipation due to ferrous iron and possible reactions like nausea from zinc sulphate monohydrate. The placebo should have no active side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I speak English and can understand and sign a consent form.

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I am between 18 and 35 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am scheduled for surgery during this study.

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I have a history of specific health conditions or treatments that might affect study participation.

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I am taking vitamin or mineral supplements that contain iron or zinc.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ six months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~six months

This trial's timeline: 3 weeks for screening, Varies for treatment, and six months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

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

Change in haemoglobin (Hb) concentrations from enrolment (baseline), to midline (three months), and endline (six months).

Concentrations of key circulating pro-inflammatory biomarkers at baseline, three months, and six months.

+14 more

Other study objectives

Exploratory: Microbial metabolome.

Exploratory: Microbial metagenome inferred function.

Exploratory: Microbial metagenome.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active interventionExperimental Treatment1 Intervention

Mineral-enriched powder

Group II: PlaceboPlacebo Group1 Intervention

Placebo powder

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Iron supplementation, particularly with ferrous iron, works by increasing the absorption of iron in the intestine, which raises hemoglobin and serum ferritin levels, essential for oxygen transport and storage. Zinc supplementation supports the immune system and enzyme functions, potentially enhancing iron absorption. This dual approach is crucial for iron deficiency patients as it not only corrects iron levels but also supports overall health and metabolic functions.

Effect of sodium iron ethylenediaminetetra-acetate (NaFeEDTA) on haemoglobin and serum ferritin in iron-deficient populations: a systematic review and meta-analysis of randomised and quasi-randomised controlled trials.