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A Pilot Study Comparing Tolerance of Oral Heme Iron Polypeptide With Oral Ionic Iron

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01865175
Recruitment Status : Withdrawn (Institution required IND, although FDA did not, so institution did not allow enrollment)
First Posted : May 30, 2013
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Andrew S. Freiberg, Milton S. Hershey Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Iron Deficiency Drug: ionic iron Drug: heme iron polypeptide Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Comparing Tolerance of Oral Heme Iron Polypeptide With Oral Ionic Iron
Study Start Date : January 2016
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

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.
Drug: 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.
Other Name: Ferrous Sulphate

Drug: 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 Names:
  • Proferrin
  • HIP

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.
Drug: 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.
Other Name: Ferrous Sulphate

Drug: 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 Names:
  • Proferrin
  • HIP




Primary Outcome Measures :
  1. tolerance [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • able to fill out daily diary

Exclusion Criteria:

  • known iron overload
  • sensitivity to either product used

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865175


Locations
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United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Andrew S Freiberg, M.D. Penn State University

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Responsible Party: Andrew S. Freiberg, Associate Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01865175    
Other Study ID Numbers: HIP ASF1
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs