A Pilot Study Comparing Tolerance of Oral Heme Iron Polypeptide With Oral Ionic Iron
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Iron Deficiency Anemia, Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 7 - 70 |
| Updated: | 4/2/2016 |
| Start Date: | January 2016 |
| End Date: | May 2016 |
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.
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.
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.
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.
Inclusion Criteria:
- able to fill out daily diary
Exclusion Criteria:
- known iron overload
- sensitivity to either product used
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