A Pilot Study Comparing Tolerance of Oral Heme Iron Polypeptide With Oral Ionic Iron
NCT ID: NCT01865175
Last Updated: 2016-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2016-01-31
2016-05-31
Brief Summary
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Hypothesis: Heme iron polypeptide is associated with fewer gastrointestinal side effects than ionic iron.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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.
ionic iron
Subjects will take ionic iron daily for 7 days followed by 7 days of no medicine followed by 7 days of heme iron.
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.
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.
ionic iron
Subjects will take ionic iron daily for 7 days followed by 7 days of no medicine followed by 7 days of heme iron.
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.
Interventions
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ionic iron
Subjects will take ionic iron daily for 7 days followed by 7 days of no medicine followed by 7 days of heme iron.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* sensitivity to either product used
7 Years
70 Years
ALL
Yes
Sponsors
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Milton S. Hershey Medical Center
OTHER
Responsible Party
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Andrew S. Freiberg
Associate Professor
Principal Investigators
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Andrew S Freiberg, M.D.
Role: PRINCIPAL_INVESTIGATOR
Penn State University
Locations
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Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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Other Identifiers
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HIP ASF1
Identifier Type: -
Identifier Source: org_study_id
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