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Iron Supplement

Ferrous sulfate for Iron-Deficiency Anemia

N/A
Waitlist Available
Led By Manju B Reddy, PhD
Research Sponsored by Iowa State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0,1,2,3,4,6 and 8 hours
Awards & highlights

Summary

The objective of this study is to examine patient-reported gastrointestinal side effects, as well as iron status indicators, inflammatory markers and oxidative stress following administration of ferrous sulfate and iron-enriched Aspergillus oryzae supplementation.

Eligible Conditions
  • Iron-Deficiency Anemia
  • Iron Overload

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0,1,2,3,4,6 and 8 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0,1,2,3,4,6 and 8 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the NTBI curve over 8 hours
Area under the percent transferrin saturation curve over 8 hours
Area under the serum iron curve over 8 hours
Secondary outcome measures
Change in C-reactive protein
Change in alanine aminotransferase (ALT)
Aspartate Transaminase
+12 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Ferrous sulfateExperimental Treatment1 Intervention
Subjects will take a 65 mg Fe capsule of ferrous sulfate, once daily for 21 consecutive days. The first treatment capsule will be consumed with a semi-purified meal (egg albumin, sugar, vanilla, maltodextrose and corn oil) and will have blood drawn hours 0, 1, 2, 3, 4, 6 and 8 post consumption. Serum will be used to determine non-transerrin bound iron, serum iron and percent saturation. Throughout the treatment period, subjects are informed to consume the capsule with food and report symptoms in an online questionnaire. Following three weeks treatment, participants return for a blood draw and oxidative stress indicators are measured. A three week washout period with placebo treatment takes place between treatment crossover.
Group II: AspironExperimental Treatment1 Intervention
AspironTM which is an iron-enriched supplement will follow the same guidelines and protocol as ferrous sulfate arm. Equivalent 65 mg Fe per capsule will be administered to participants.
Group III: PlaceboPlacebo Group1 Intervention
Participants will follow the same description for the other two experimental treatment groups. Capsules will be given to subjects in opaque formation, therefore will be unable to differentiate the iron supplements.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ferrous sulfate
2008
Completed Phase 4
~2450
Aspiron
2016
N/A
~70

Find a Location

Who is running the clinical trial?

Iowa State UniversityLead Sponsor
59 Previous Clinical Trials
144,536 Total Patients Enrolled
Manju B Reddy, PhDPrincipal InvestigatorIowa State University
3 Previous Clinical Trials
83 Total Patients Enrolled
~2 spots leftby Sep 2025
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