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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, three months, six months

Awards & highlights

Study Summary

This trial will determine whether taking a mineral-enriched powder daily for six months can raise iron levels in women with iron deficiency.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, three months, six months, and seven months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, three months, six months, and seven months

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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.

Secondary outcome measures

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 outcome measures

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Carleton UniversityLead Sponsor

2 Previous Clinical Trials

38 Total Patients Enrolled

Lucky Iron Fish EnterpriseUNKNOWN

Hopital MontfortOTHER

13 Previous Clinical Trials

12,045 Total Patients Enrolled

Media Library

Mineral-enriched powder (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05990166 — Phase 2

Iron Deficiency Research Study Groups: Active intervention, Placebo

Iron Deficiency Clinical Trial 2023: Mineral-enriched powder Highlights & Side Effects. Trial Name: NCT05990166 — Phase 2

Mineral-enriched powder (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05990166 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Active intervention obtained the necessary sanction from the FDA?

"Our team's assessment of the safety profile for this intervention was graded a 2 as it is still in Phase 2, which implies that there are some affirmative indications on its security but no evidence yet to support efficacy."

Answered by AI

What type of individuals are most suitable to engage with this clinical investigation?

"This clinical trial has a recruitment quota of 130 applicants and is seeking individuals between the ages of 18 to 35 who have been diagnosed with iron deficiency."

Answered by AI

Are there any available vacancies in this clinical trial?

"Affirmative. The clinicaltrials.gov database indicates that, as of August 10th 2023, this trial is actively recruiting for 130 patients at a single site since its inception on April 27th 2023."

Answered by AI

What is the projected enrollment count for this research endeavor?

"Yes, the information on clinicialtrials.gov affirms that this clinical trial is actively recruiting. This medical research was first published in April of 2023 and refreshed most recently in August of the same year. The study seeks to recruit 130 patients from a single site."

Answered by AI

Is the upper age limit for participation in this trial 85 years or older?

"The inclusionary conditions for this clinical trial specify that participants must be between the ages of 18 and 35. That being said, there are 19 separate trials geared towards minors and 36 studies targetting individuals above 65 years old."

Answered by AI