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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02734641
Other study ID # 155-15EMC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2016
Est. completion date April 17, 2018

Study information

Verified date December 2018
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 111
Est. completion date April 17, 2018
Est. primary completion date April 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Haemek medical center Afula

Sponsors (1)

Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ghrelin levels after treatment with Intravenous Iron 12 weeks
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