AnemiaNCT02734641
Does Increase in Appetite After Iron Treatment Induced by Ghrelin Hormone
An observational study of Anemia, run by HaEmek Medical Center, Israel at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anemia
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 111 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2016to 17 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Iron deficiency anemia that wasn't responded to oral treatment or wasn't tolerable due to side effects
- sign and dated informed consent form.
Who cannot join
- chronic inflammatory disease.
- chronic renal failure
- active cancer.
- active Infectious disease.
- non iron deficiency anemia.
- pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anemia
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Ghrelin levels after treatment with Intravenous Iron
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startAug 2016
- Primary completion1 Apr 2017
- Study completion17 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- mazen Elias, prof, Principal investigator, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734641
- Sponsor's protocol ID
- 155-15EMC
- Status last verified
- Dec 2018
- First submitted
- 4 Feb 2016
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Increase in Appetite After Iron Treatment Induced by Ghrelin Hormone
- ClinicalTrials.gov ID
- NCT02734641
- Acronym / sponsor ID
- 155-15EMC
- Conditions
- Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 17 Apr 2018 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Iron deficiency anemia that wasn't responded to oral treatment or wasn't tolerable due to side effects
- sign and dated informed consent form.
Key exclusion criteria (6 listed)
- chronic inflammatory disease.
- chronic renal failure
- active cancer.
- active Infectious disease.
- non iron deficiency anemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ghrelin levels after treatment with Intravenous Iron
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mazen Elias, prof principal investigator
HaEmek Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ghrelin levels after treatment with Intravenous Iron (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.