- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01865175
A Pilot Study Comparing Tolerance of Oral Heme Iron Polypeptide With Oral Ionic Iron
This is a pilot study designed to compare the tolerance of ionic iron (ferrous sulphate) with heme iron polypeptide. Subjects will take one week of one product followed by a week with no product followed by a week with the other product. Subjects will complete a daily diary to assess side effects.
Hypothesis: Heme iron polypeptide is associated with fewer gastrointestinal side effects than ionic iron.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Iron deficiency anemia (IDA) is a worldwide problem in both children and adults. Traditional ionic oral iron supplements have many disadvantages including high gastrointestinal side effects, poor and variable absorption, poor compliance, and the potential for overdose, especially in children. Proferrin is a currently available form of heme iron polypeptide (HIP). It is different from older more traditional iron formulations, such as ferrous sulphate, in that it is heme iron as opposed to ionic iron. The porphyrin ring of heme allows the iron to be absorbed through a different receptor than ionic iron resulting in different absorption kinetics and GI side effect profiles. The absorption of HIP is via the same mechanism as dietary iron contained in meat. Therefore, heme iron therapy may avoid several problems associated with ionic iron therapy such as gastrointestinal side effects and absorption that is dependent on food intake.
30 subjects will be enrolled, randomized to starting with one or the other study drug, but crossing over to the other, so that all subjects will be in a single cohort. This is an open label randomized pilot study intended to test the feasibility of collecting information on drug tolerance. The randomization will be stratified by age, gender and hemoglobin.
An optional baseline blood test will be drawn (CBC, iron profile, ferritin). If subjects decide to participate in the optional blood draws, they will return during the week they are not taking either study medication for this test. For subjects not participating in the optional blood tests and not needing to return to the clinic for another reason, subjects will be contacted by phone (or in person if returning to the clinic for another reason) during the week not taking either medication to address any concerns or issues. If not agreeing to participate in the blood tests, they will be allowed to send the empty pill bottles and the diary by mail and will be contacted by phone to make sure there were no problems during the study. If participating in the optional blood tests, within one month after taking the final pill, subjects will return to the clinic to return the medication containers and study diary.
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Hershey Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- able to fill out daily diary
Exclusion Criteria:
- known iron overload
- sensitivity to either product used
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ionic iron
Subjects will take ionic iron daily for 7 days followed by 7 days of no medicine folloowed by 7 days of heme iron.
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Subjects will take ionic iron daily for 7 days followed by 7 days of no medicine followed by 7 days of heme iron.
Other Names:
Subject will take heme iron daily for 7 days followed by 7 days of no medicine followed by 7 days of ionic iron.
Other Names:
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Experimental: heme iron polypeptide
Subject will take heme iron daily for 7 days followed by 7 days of no medicine followed by 7 days of ionic iron.
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Subjects will take ionic iron daily for 7 days followed by 7 days of no medicine followed by 7 days of heme iron.
Other Names:
Subject will take heme iron daily for 7 days followed by 7 days of no medicine followed by 7 days of ionic iron.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
tolerance
Time Frame: 4 weeks
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4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrew S Freiberg, M.D., Penn State University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIP ASF1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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