NCT01865175

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 30, 2013

Completed
2.6 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

4 months

First QC Date

May 26, 2013

Last Update Submit

September 12, 2016

Conditions

Iron Deficiency

Outcome Measures

Primary Outcomes (1)

  • tolerance

    4 weeks

Study Arms (2)

ionic iron

ACTIVE COMPARATOR

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 ironDrug: heme iron polypeptide

heme iron polypeptide

EXPERIMENTAL

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 ironDrug: heme iron polypeptide

Interventions

ionic ironDRUG

Subjects will take ionic iron daily for 7 days followed by 7 days of no medicine followed by 7 days of heme iron.

Also known as: Ferrous Sulphate
heme iron polypeptideionic iron
heme iron polypeptideDRUG

Subject will take heme iron daily for 7 days followed by 7 days of no medicine followed by 7 days of ionic iron.

Also known as: Proferrin, HIP
heme iron polypeptideionic iron

Eligibility Criteria

Age7 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • able to fill out daily diary

You may not qualify if:

  • known iron overload
  • sensitivity to either product used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Iron Deficiencies

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Andrew S Freiberg, M.D.

    Penn State University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 26, 2013

First Posted

May 30, 2013

Study Start

January 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 14, 2016

Record last verified: 2016-09

Locations

US(1)