Serum Hepcidin Immunoassay - Laboratory to Marketplace

Description

This is a single center, prospective, observational study to demonstrate the clinical validity of the Intrinsic LifeSciences (ILS) Intrinsic Hepcidin IDx™ Test in the diagnosis and management of iron deficiency (ID) in adolescents and young adults. This test is considered non-significant risk.

Study Start Date

June, 30 2016

Estimated Completion Date

December 2017

Interventions

  • Diagnostic Test: Intrinsic Hepcidin IDx™ Test

Study ID

Intrinsic LifeSciences, LLC -- ILS-0001

Status

Recruiting

Trial ID

NCT03310736

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

650

Sponsor

Intrinsic LifeSciences, LLC

Inclusion Criteria

  • Age at least 11 years
  • Subjects must give informed assent/ consent prior to the blood draw. Subjects that are minors (<18 years) must have a parent or guardian give informed consent and the subject must give assent to participate in the study.
  • Willing to comply with all oral iron supplementation and follow up visits if they move to the Observation of Treatment Phase.
  • Able to communicate in English.

Exclusion Criteria

  • Acute febrile illness (Temp ?100.4°F (38°C), or acute otitis media, gastroenteritis, pharyngitis or other URI, within the previous one week.
  • History of known hemoglobinopathy (e.g., thalassemia trait or sickle cell)
  • Any parenteral iron received in the 30 days prior to enrollment.
  • Presently taking oral iron supplements (except for iron as part of multivitamin or oral contraceptive pill) or has taken it in the 30 days prior to enrollment.
  • An allergy or hypersensitivity to oral iron sulfate.
  • Has received a blood transfusion in the 90 days prior to enrollment.
  • Any investigational drug use in the 30 days prior to enrollment.
  • Any known malignancy.
  • Receiving dialysis.
  • Known to be pregnant or currently breast-feeding.
  • Any lab abnormality, medical condition, or psychiatric disorder which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.

Gender

All

Ages

11 Years and older

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (5)

Study Location Distance Name Phone Email
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Kate E Hein MHS 617-919-1305 katherine.hein@childrens.harvard.edu
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Kate E Hein MHS 617-919-1305 katherine.hein@childrens.harvard.edu
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Kate E Hein MHS 617-919-1305 katherine.hein@childrens.harvard.edu
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Kate E Hein MHS 617-919-1305 katherine.hein@childrens.harvard.edu
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Kate E Hein MHS 617-919-1305 katherine.hein@childrens.harvard.edu

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