Does Increase in Appetite After Iron Treatment Induced by Ghrelin Hormone

NCT ID: NCT02734641

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-04-17

Brief Summary

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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.

Detailed Description

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Prior to Iron treatment Investigator will sample subject blood for: counting blood, iron sector indices, renal function, electrolytes, and measure the level of ghrelin fasting plasma. In addition, the patient will fill a structured questionnaire that examines appetite levels. participants will be asked to answer a structured questionnaire which will include information on demographics, clinical data (fever, allergies, weight, height) and comorbidities. Additional data on laboratory tests, comorbidities, medication and regular blood and urine cultures results will be taken from the medical file. Iron treatment will be given according to local standard procedure . At the end of the treatment ghrelin levels and questionaire will be retaken .

iron deficiency anemia is defined: hemoglobin \<12 gr / dl in women and Hb \<13 gr / dl in men with ferritin \<15 ng / ml.

Conditions

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Anemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* chronic inflammatory disease.
* chronic renal failure
* active cancer.
* active Infectious disease.
* non iron deficiency anemia.
* pregnancy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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mazen Elias, prof

Role: PRINCIPAL_INVESTIGATOR

HaEmek Medical Center, Israel

Locations

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Haemek medical center

Afula, , Israel

Site Status

Countries

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Israel

Other Identifiers

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155-15EMC

Identifier Type: -

Identifier Source: org_study_id