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

NCT01865175 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2016-09-14

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Andrew S Freiberg, M.D. · Penn State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
7 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01865175 on ClinicalTrials.gov