Microcytic Hypochromic AnemiaNCT03868306
Red Cell Distribution Width Index Versus Red Cell Distribution Width as Discriminating Guide for Iron Deficiency Anaemia and Beta Thalassemia Trait .
An observational study of Microcytic Hypochromic Anemia, run by Assiut University.
Trial summary
Red Cell Distribution Width Index versus Red Cell Distribution Width as Discriminating Guide for Iron Deficiency Anaemia and Beta Thalassemia Trait . Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Microcytic Hypochromic Anemia
- What is being tested?
- CBC , Iron study and Haemoglobin electrophoresis .
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2019to 1 Jun 2022
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study will conducting on 100 patients of microcytic hypochromic anaemia who recruited from the hematology outpatient clinic , Assiut University Children Hospital .
Who may be able to join
- All patients with microcytic hypochromic anemia ( according to WHO , MCV less than 80 fl and HB level below the lower limit of normal value specified by age and gender .
Who cannot join
- Beta thalassemia major patients .
- Chronic diseases or infections .
- Lead poisoning .
- Sideroblastic anaemia .
Trial locations and contacts
No sites are listed yet.
About this study
Red Cell Distribution Width Index versus Red Cell Distribution Width as Discriminating Guide for Iron Deficiency Anaemia and Beta Thalassemia Trait .
Read the detailed description
Microcytic hypochromic anaemia is very common hematological abnormality in the clinical practice ( Snakar et;al. 2016 ) . Iron deficiency anaemia and beta thalassemia trait are the most common causes of microcytic hypochromic anaemia. As mentioned by the World Health Organization ( WHO ) estimates in 2004 , there were 273000deaths due to iron deficiency anaemia along with 19.7 million disability . Approximately 1.3 % cases were recorded globally in developing countries ( Kasseban et;al.2014 ) . Iron deficiency anemia is the most common nutritional disorder . This type of anemia is the final phase of a process that begins with exhaustion of iron stores and continues with iron depletion from other compartments that contain it compromising normal haematopoesis ( Wharton et;al. 1994 ) Beta thalassemia trait is the second most common cause of microcytic hypochromic anaemia . It is genetically determined disorder in which the defect of b globin gene results in decreased production of hemoglobin A1 ( Sliman et;al. 2004 ) The differentiation between Iron deficiency anemia and Beta thalassemia trait is important because of two main reasons . First , because hemoglobin will not improve in beta thalassemia trait if it is misdiagnosed as Iron deficiency anemia and unnecessary iron being prescribed by the attending physician ( Vehapoglee et;al. 2014 ) . The second grave reason is that misdiagnosed beta thalassemia trait as Iron deficiency anemia may get married to a beta thalassemia trait , resulting in homozygous or thalassemia major in the offsprings ( Tripathi et;al. 2015) Ideally one needs a battery of tests including detailed peripheral blood picture , HBA2 estimation , serum iron , TIBC , serum ferritin and transferrin saturation to differentiate Iron deficiency anemia from beta thalassemia trait clearly (Bordbar et;al. 2015 ) . But all these investigations are either not available in all clinical setup or they are relatively time consuming and need expensive techniques ( Natios et;al. 2007 ). Derived indices showed that RDW is the first index of the routine blood count to become abnormal during the development of Iron deficiency anemia ( McCulre et;al. 1985 ) . It quantitatively measures red blood cells size.
variation computed directly from the RBCs histogram and is calculated as standard statistical value , the coefficient of variation of the volume distribution ( Verma et;al. 2015 and Plengsures et;al. 2015) . RDW is high in Iron deficiency anemia because there is a wide variation in red cell size . in beta thalassemia trait , the red cells are all the same size , there is virtually no variation ,so RDW is low ( Park et;al.2009 ) . Another red cell discriminate function , RDWI had been proven to be reliable discrimination index in the differentiation between Iron deficiency anemia and beta thalassemia trait ( Ismail et;al.2016 ) . It can be easily calculated as ( MCV in ( Fl) x RDW / RBCs in (million per microlitre ) ) quotient more than 220 suggest Iron deficiency anemia
, less than 220 suggest beta thalassemia trait. RDWI provide valiable help to the attending physician as all discriminating factors including RBCs count , MCV and RDW are incorporated in its formula ( Jayabose et;al. 1999 ) .
- Conditions
- Microcytic Hypochromic Anemia
- Being tested
- CBC , Iron study and Haemoglobin electrophoresis .
- Medical subject headings
- Anemia, hypochromic microcytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBC , Iron study and Haemoglobin electrophoresis .Other
The study will conducting on 100 patients of microcytic hypochromic anaemia who recruited from the hematology outpatient clinic , Assiut University Children Hospital . Beside history and clinical examination , the studied cases will be subjected to the following investigations Complete blood count ( CBC ) with comparison of MCV , RBCs count , RDW and RDWI . Determination of serum ferritin , serum iron and total iron bending capacity ( TIBC ) . HB electrophoresis . Patient with HBA2 more than 3.2 % are identified as beta thalassemia trait and patients with serum ferritin less than 12 ng / ml are identified as IDA cases. Validity of both discrimination indices are evaluated by calculating there sensitivity , specificity , positive predictive value , negative predictive value and Youden index ( YI ) Based on statistical criteria in ideal test should have high sensitivity and specificity and Youden index.
| Study group | Role | What they receive |
|---|---|---|
| Iron deficiency anaemia | Microcytic hypochromic anaemic patients with serum ferritin less than 12 Ng /ml Receives: Other: CBC , Iron study and Haemoglobin electrophoresis . | |
| Beta thalassemia Trait | Microcytic hypochromic anaemic patients with HBA2 more than 3.2 % Receives: Other: CBC , Iron study and Haemoglobin electrophoresis . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic comparison of both the RDWI and RDW in the differentiation of Iron deficiency anemia and Beta thalassemia trait
RDW is high in Iron deficiency anemia because there is a wide variation in red cell size . in beta thalassemia trait , the red cells are all the same size , there is virtually no variation ,so RDW is low ( Park et;al.2009 ) . Another red cell discriminate function , RDWI had been proven to be reliable discrimination index in the differentiation between Iron deficiency anemia and beta thalassemia trait ( Ismail et;al.2016 ) . It can be easily calculated as ( MCV in ( Fl) x RDW / RBCs in (million per microlitre ) ) quotient more than 220 suggest Iron deficiency anemia
, less than 220 suggest beta thalassemia trait.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start1 Jun 2019 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microcytic Hypochromic AnemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868306
- Sponsor's protocol ID
- RCDWIVRCDWADGFIDAABTT
- Status last verified
- Mar 2019
- First submitted
- 7 Mar 2019
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Cell Distribution Width Index Versus Red Cell Distribution Width as Discriminating Guide for Iron Deficiency Anaemia and Beta Thalassemia Trait .
- ClinicalTrials.gov ID
- NCT03868306
- Acronym / sponsor ID
- RCDWIVRCDWADGFIDAABTT
- Conditions
- Microcytic Hypochromic Anemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 11 Mar 2019 (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.
Red Cell Distribution Width Index versus Red Cell Distribution Width as Discriminating Guide for Iron Deficiency Anaemia and Beta Thalassemia Trait .
Detailed description
Microcytic hypochromic anaemia is very common hematological abnormality in the clinical practice ( Snakar et;al. 2016 ) . Iron deficiency anaemia and beta thalassemia trait are the most common causes of microcytic hypochromic anaemia. As mentioned by the World Health Organization ( WHO ) estimates in 2004 , there were 273000deaths due to iron deficiency anaemia along with 19.7 million disability . Approximately 1.3 % cases were recorded globally in developing countries ( Kasseban et;al.2014 ) . Iron deficiency anemia is the most common nutritional disorder . This type of anemia is the final phase of a process that begins with exhaustion of iron stores and continues with iron depletion from other compartments that contain it compromising normal haematopoesis ( Wharton et;al. 1994 ) Beta thalassemia trait is the second most common cause of microcytic hypochromic anaemia . It is genetically determined disorder in which the defect of b globin gene results in decreased production of hemoglobin A1 ( Sliman et;al. 2004 ) The differentiation between Iron deficiency anemia and Beta thalassemia trait is important because of two main reasons . First , because hemoglobin will not improve in beta thalassemia trait if it is misdiagnosed as Iron deficiency anemia and unnecessary iron being prescribed by the attending physician ( Vehapoglee et;al. 2014 ) . The second grave reason is that misdiagnosed beta thalassemia trait as Iron deficiency anemia may get married to a beta thalassemia trait , resulting in homozygous or thalassemia major in the offsprings ( Tripathi et;al. 2015) Ideally one needs a battery of tests including detailed peripheral blood picture , HBA2 estimation , serum iron , TIBC , serum ferritin and transferrin saturation to differentiate Iron deficiency anemia from beta thalassemia trait clearly (Bordbar et;al. 2015 ) . But all these investigations are either not available in all clinical setup or they are relatively time consuming and need expensive techniques ( Natios et;al. 2007 ). Derived indices showed that RDW is the first index of the routine blood count to become abnormal during the development of Iron deficiency anemia ( McCulre et;al. 1985 ) . It quantitatively measures red blood cells size.
variation computed directly from the RBCs histogram and is calculated as standard statistical value , the coefficient of variation of the volume distribution ( Verma et;al. 2015 and Plengsures et;al. 2015) . RDW is high in Iron deficiency anemia because there is a wide variation in red cell size . in beta thalassemia trait , the red cells are all the same size , there is virtually no variation ,so RDW is low ( Park et;al.2009 ) . Another red cell discriminate function , RDWI had been proven to be reliable discrimination index in the differentiation between Iron deficiency anemia and beta thalassemia trait ( Ismail et;al.2016 ) . It can be easily calculated as ( MCV in ( Fl) x RDW / RBCs in (million per microlitre ) ) quotient more than 220 suggest Iron deficiency anemia
, less than 220 suggest beta thalassemia trait. RDWI provide valiable help to the attending physician as all discriminating factors including RBCs count , MCV and RDW are incorporated in its formula ( Jayabose et;al. 1999 ) .
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron deficiency anaemia | – | Other: CBC , Iron study and Haemoglobin electrophoresis .Microcytic hypochromic anaemic patients with serum ferritin less than 12 Ng /ml |
| Beta thalassemia Trait | – | Other: CBC , Iron study and Haemoglobin electrophoresis .Microcytic hypochromic anaemic patients with HBA2 more than 3.2 % |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study will conducting on 100 patients of microcytic hypochromic anaemia who recruited from the hematology outpatient clinic , Assiut University Children Hospital .
Key inclusion criteria (1 listed)
- All patients with microcytic hypochromic anemia ( according to WHO , MCV less than 80 fl and HB level below the lower limit of normal value specified by age and gender .
Key exclusion criteria (4 listed)
- Beta thalassemia major patients .
- Chronic diseases or infections .
- Lead poisoning .
- Sideroblastic anaemia .
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 |
|---|---|---|
| CBC , Iron study and Haemoglobin electrophoresis .The study will conducting on 100 patients of microcytic hypochromic anaemia who recruited from the hematology outpatient clinic , Assiut University Children Hospital . Beside history and clinical examination , the studied cases will be subjected to the following investigations Complete blood count ( CBC ) with comparison of MCV , RBCs count , RDW and RDWI . Determination of serum ferritin , serum iron and total iron bending capacity ( TIBC ) . HB electrophoresis . Patient with HBA2 more than 3.2 % are identified as beta thalassemia trait and patients with serum ferritin less than 12 ng / ml are identified as IDA cases. Validity of both discrimination indices are evaluated by calculating there sensitivity , specificity , positive predictive value , negative predictive value and Youden index ( YI ) Based on statistical criteria in ideal test should have high sensitivity and specificity and Youden index. | Other | Beta thalassemia Trait, Iron deficiency anaemia |
Primary outcome
Diagnostic comparison of both the RDWI and RDW in the differentiation of Iron deficiency anemia and Beta thalassemia trait
Time frame: Baseline
RDW is high in Iron deficiency anemia because there is a wide variation in red cell size . in beta thalassemia trait , the red cells are all the same size , there is virtually no variation ,so RDW is low ( Park et;al.2009 ) . Another red cell discriminate function , RDWI had been proven to be reliable discrimination index in the differentiation between Iron deficiency anemia and beta thalassemia trait ( Ismail et;al.2016 ) . It can be easily calculated as ( MCV in ( Fl) x RDW / RBCs in (million per microlitre ) ) quotient more than 220 suggest Iron deficiency anemia , less than 220 suggest beta thalassemia trait.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Microcytic Hypochromic Anemia, 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 4 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 11 Mar 2019. 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 Ahmed Gad Al-Rab Askar, Professor (00201010630005, Hekma73@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic comparison of both the RDWI and RDW in the differentiation of Iron deficiency anemia and Beta thalassemia trait (time frame: Baseline). 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 11 Mar 2019.