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

September 12, 2016 updated by: Andrew S. Freiberg, Milton S. Hershey Medical Center

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

Withdrawn

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

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • able to fill out daily diary

Exclusion Criteria:

  • known iron overload
  • sensitivity to either product used

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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 Names:
  • 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
tolerance
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Andrew S Freiberg, M.D., Penn State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

May 26, 2013

First Submitted That Met QC Criteria

May 29, 2013

First Posted (Estimate)

May 30, 2013

Study Record Updates

Last Update Posted (Estimate)

September 14, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

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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