Does Increase in Appetite After Iron Treatment Induced by Ghrelin Hormone

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.

Study Overview

• Status: Completed
• Conditions: Anemia

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel, 18101
    • HaEmek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ghrelin levels after treatment with Intravenous Iron	12 weeks

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel
• Investigators: Principal Investigator: mazen elias, prof, HaEmek Medical Center, Israel

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 17, 2018

Study Registration Dates

• First Submitted: February 4, 2016
• First Submitted That Met QC Criteria: April 6, 2016
• First Posted (Estimate): April 12, 2016

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 17, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 155-15EMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED