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Iron Supplement

Ferrous sulfate for Iron-Deficiency Anemia

N/A
Waitlist Available
Led By Simin N Meydani, DVM, PhD
Research Sponsored by Tufts University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial is testing two new forms of iron to see if they are better than the current form of iron used to treat iron deficiency.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bacterial proliferation potential
Fecal calprotectin
Malaria infectivity
Secondary outcome measures
Biochemical markers of intestinal inflammation, such as fecal cytokines
Biochemical markers of iron status, such as ferritin
Biochemical markers of redox stress, such as F2α-isoprostanes
+3 more

Side effects data

From 2022 Phase 4 trial • 13 Patients • NCT05007899
60%
Heartburn
60%
Abdominal pain
40%
Constipation
20%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daily
Alternate Day

Trial Design

8Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Adult ferrous sulfate weeklyExperimental Treatment1 Intervention
Iron-replete postmenopausal women, and men, receiving ferrous sulfate weekly (containing 60 mg Fe per day) for 4 weeks.
Group II: Adult ferrous sulfate + micronutrientExperimental Treatment1 Intervention
Iron-replete postmenopausal women, and men, receiving ferrous sulfate + micronutrient supplement (containing 60 mg Fe per day) for 4 weeks.
Group III: Adult IHATExperimental Treatment1 Intervention
Iron-replete postmenopausal women, and men, receiving IHAT (containing 60 mg Fe per day) for 4 weeks. In Phase II, iron-replete postmenopausal women, and men, receiving IHAT (containing 120 mg Fe per day) for 4 weeks
Group IV: Adult Ferrous sulfate dailyExperimental Treatment1 Intervention
Iron-replete postmenopausal women, and men, receiving ferrous sulfate daily (containing 60 mg Fe per day) for 4 weeks. In Phase II, iron-replete postmenopausal women, and men, receiving ferrous sulfate daily (containing 120 mg Fe per day) for 4 weeks.
Group V: Adult AspironExperimental Treatment1 Intervention
Iron-replete postmenopausal women, and men, receiving Aspiron (containing 60 mg Fe per day) for 4 weeks. In Phase II, iron-replete postmenopausal women, and men, receiving Aspiron (containing 120 mg Fe per day) for 4 weeks.
Group VI: Non-iron-deficient childrenActive Control1 Intervention
Non-iron-deficient children aged 6-24 months used as a reference.
Group VII: Iron-deficient childrenActive Control1 Intervention
Previously iron-deficient children aged 6-24 months on iron therapy. Ferrous sulfate administered at 4 mg Fe/kg/d per standard of care.
Group VIII: Adult PlaceboPlacebo Group1 Intervention
Iron-replete postmenopausal women, and men, receiving placebo daily for 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IHAT
2018
Completed Phase 2
~680
Aspiron
2016
N/A
~70
Ferrous sulfate
2008
Completed Phase 4
~2450

Find a Location

Who is running the clinical trial?

Bill and Melinda Gates FoundationOTHER
407 Previous Clinical Trials
22,923,961 Total Patients Enrolled
Tufts UniversityLead Sponsor
267 Previous Clinical Trials
662,073 Total Patients Enrolled
Simin N Meydani, DVM, PhDPrincipal InvestigatorTufts Univeristy
4 Previous Clinical Trials
224 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safe and Effective Delivery of Supplemental Iron to Healthy Volunteers
Simin Meydani 2017. "Safe and Effective Delivery of Supplemental Iron to Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03212677.
~28 spots leftby May 2025
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