CClinicalTrials.gg
Status unknownNCT03868306Updated Mar 11, 2019

Red Cell Distribution Width Index Versus Red Cell Distribution Width as Discriminating Guide for Iron Deficiency Anaemia and Beta Thalassemia Trait .

An observational study in Microcytic Hypochromic Anemia, sponsored by Assiut University. Status unknown. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-03-11.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
100
Ages
2 Years to 18 Years
Sex
All
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Study summary

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 ) .

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Conditions studied

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In context

Anemia

1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 326 observational studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study will conducting on 100 patients of microcytic hypochromic anaemia who recruited from the hematology outpatient clinic , Assiut University Children Hospital .

Inclusion criteria

  • 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 .

Exclusion criteria

Exclusion Criteria:

  • Beta thalassemia major patients .
  • Chronic diseases or infections .
  • Lead poisoning .
  • Sideroblastic anaemia .
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Iron deficiency anaemia

    Microcytic hypochromic anaemic patients with serum ferritin less than 12 Ng /ml

    Other: CBC , Iron study and Haemoglobin electrophoresis .

  • Beta thalassemia Trait

    Microcytic hypochromic anaemic patients with HBA2 more than 3.2 %

    Other: CBC , Iron study and Haemoglobin electrophoresis .

Interventions

  • OtherCBC , 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03868306
Lead sponsor
Assiut University
Responsible party
Rania (Principal investigator, Assiut University) — Principal investigator
First posted
Mar 11, 2019
Start date
Jun 1, 2019 (estimated)
Primary completion
Jun 1, 2020 (estimated)
Completion
Jun 1, 2022 (estimated)
Last update
Mar 11, 2019

Study contacts

Ahmed Gad Al-Rab Askar, Professor
Contact
Hekma73@hotmail.com
00201010630005
Hekma Saad Farghaly, Doctor
Contact
Hekma73@hotmail.com
00201091251040

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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