Iron Deficiency, Anaemia in ChildrenIDANCT03482076
Iron Deficiency Anemia in Childern With Liver Cirrhosis
A study testing transferrin receptor concentration in people with Iron Deficiency, Anaemia in Children and Liver Cirrhosis, run by Assiut University.
Trial summary
Iron deficiency anemia is a common complication of liver cirrhosis in childern and may affects there life this study to improve the outcome of these patients Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency, Anaemia in Children, Liver Cirrhosis
- What is being tested?
- transferrin receptor concentration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2019to 1 Jun 2020
- Phase
- Interventional
- 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 1 month to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- all childern with liver cirrhosis in GIT and hepatology unit
Who cannot join
- Neonates less than one month
- childern with other liver diseases
Trial locations and contacts
No sites are listed yet.
Nagla Hassan Ibrahim contact
About this study
Official title: Prevelance of Iron Deficiency Anemia in Liver Cirrhosis in Childern
Iron deficiency anemia is a common complication of liver cirrhosis in childern and may affects there life this study to improve the outcome of these patients
Read the detailed description
Patients with cirrhosis are at risk of developing both IDA and anemia of chronic disease concomitantly, and there adverse effects can deteriorate general condition and affect of quality of life in these patients .Also because it is easier to correct IDA than anemia of chronic disease, so this study of the prevalence of IDA helping us in the diagnosis and treatment of IDA and can reduce the need for other diagnostic tests and improve the quality of life in patients with cirrhosis .
- Being tested
- transferrin receptor concentration
- Medical subject headings
- Iron Deficiencies, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transferrin receptor concentrationDiagnostic test
Sandwich radio-imunoassay
| Study group | Role | What they receive |
|---|---|---|
| transferrin receptor concentration | Other | Prevelance of iron deficiency in this patients Receives: Diagnostic Test: transferrin receptor concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevelance of IDA in liver cirrhosis
To evaluate results
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Mar 2019 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency, Anaemia in ChildrenStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahaa Khaled Mohamed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482076
- Sponsor's protocol ID
- DBK
- Acronym
- IDA
- Status last verified
- Mar 2018
- First submitted
- 23 Mar 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevelance of Iron Deficiency Anemia in Liver Cirrhosis in Childern
- ClinicalTrials.gov ID
- NCT03482076
- Acronym / sponsor ID
- IDA / DBK
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 29 Mar 2018 (actual)
- 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.
Iron deficiency anemia is a common complication of liver cirrhosis in childern and may affects there life this study to improve the outcome of these patients
Detailed description
Patients with cirrhosis are at risk of developing both IDA and anemia of chronic disease concomitantly, and there adverse effects can deteriorate general condition and affect of quality of life in these patients .Also because it is easier to correct IDA than anemia of chronic disease, so this study of the prevalence of IDA helping us in the diagnosis and treatment of IDA and can reduce the need for other diagnostic tests and improve the quality of life in patients with cirrhosis .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transferrin receptor concentration | Other | Diagnostic Test: transferrin receptor concentrationPrevelance of iron deficiency in this patients |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- all childern with liver cirrhosis in GIT and hepatology unit
Key exclusion criteria (2 listed)
- Neonates less than one month
- childern with other liver diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transferrin receptor concentrationSandwich radio-imunoassay | Diagnostic test | transferrin receptor concentration |
Primary outcome
Prevelance of IDA in liver cirrhosis
Time frame: two years
To evaluate results
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
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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.
Nagla Hassan Ibrahim contact
Questions about this trial
What is this clinical trial studying?
A study testing transferrin receptor concentration in people with Iron Deficiency, Anaemia in Children and Liver Cirrhosis, run by Assiut University.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bahaa Khaled Mohamed (+201002755105 ext. 002, drbahaakhaled@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevelance of IDA in liver cirrhosis (time frame: two years). 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 29 Mar 2018.