NCT02734641

Brief Summary

The purpose of this study is to examine whether iron therapy in patients with intravenous iron deficiency anemia causes an increase in appetite. And whether this increase is mediated by the hormone ghrelin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

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

February 4, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2018

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

8 months

First QC Date

February 4, 2016

Last Update Submit

December 17, 2018

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Ghrelin levels after treatment with Intravenous Iron

    12 weeks

Study Arms (2)

intravenous (IV) iron therapy

Patients register to intravenous (IV) iron therapy due to iron deficiency anemia that wasn't responded to oral treatment or wasn't tolerable due to side effects. 20 mL of blood will be draw for complete blood count, renal function, electrolytes and ghrelin. In addition, the patient will fill a structured questionnaire that examines the appetite of the patient before and after treatment. At the end of Iron administration Ghrelin will be retested.

healthy volunteer

healthy volunteer, will be asked 20 mL of blood will be draw for complete blood count, renal function, electrolytes and ghrelin. In addition, the patient will fill a structured questionnaire that examines his appetite. Ghrelin will be retested after 6 weeks.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients register to intravenous (IV) iron therapy due to iron deficiency anemia that wasn't responded to oral treatment or wasn't tolerable due to side effects and healthy volunteer.

You may qualify if:

  • Iron deficiency anemia that wasn't responded to oral treatment or wasn't tolerable due to side effects
  • sign and dated informed consent form.

You may not qualify if:

  • chronic inflammatory disease.
  • chronic renal failure
  • active cancer.
  • active Infectious disease.
  • non iron deficiency anemia.
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haemek medical center

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • mazen Elias, prof

    HaEmek Medical Center, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2016

First Posted

April 12, 2016

Study Start

August 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 17, 2018

Last Updated

December 19, 2018

Record last verified: 2018-12

Locations

IL(1)