Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From

Status Active, not recruiting

Clinical Trial Summary

β thalassemia is an autosomal recessive hemoglobinopathy and considered as the most widespread genetic mutation. According to the World Health Organization (WHO) between 1.5-7% of the world population are carriers for this disease, and every year 60,000-400,000 birth of new patients are reported. In Israel, the incidence of carriers for β thalassemia is around 20% among the Jewish from Kurdish origin and around 5-10% among the Arab population.

β thalassemia is a severe disease which requires many resources, both medical and financial. The disease is expressed by chronic hemolytic anemia which requires regular blood transfusions every 3 weeks. As a result of the blood transfusions and the iron absorption by the digestive tract, those patients suffer from severe hemosiderosis which is the main mortality cause in the disease, mainly in the second decade for life. Daily treatment with iron chelator is required. Moreover, despite the actual treatment, the quality of life of those patients is still low.

Therefore the implementation of a prevention program which includes finding an effective and inexpensive way for identifying the β thalassemia carriers is a humanitary and publicly important goal.

In β thalassemia carriers, laboratory tests will show hypochromic microcytic anemia. Those findings are similar in iron deficiency anemia, but the RBC number and the RDW are normal in thalassemia carriers.

Few researchers tried in the past to determine cutoff point for diagnosis of β thalassemia carriers by different formulas.

We used the algorithm SVM (support vector machine) to find a reliable formula that can separate patients with Iron deficiency anemia/ healthy from patients with β thalassemia minor (carriers). This formula can be inserted to any automatic blood counter and search for suspected carriers without deliberately intention and without any further blood test.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00481221
Study type	Observational
Source	HaEmek Medical Center, Israel
Contact
Status	Active, not recruiting
Phase
Start date	March 2007
Completion date	December 31, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01483768` - Study of Sleeve Gastrectomy on Iron Intestinal Absorption in Morbidly Obese Patients	N/A
Completed	`NCT02888171` - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency	N/A
Recruiting	`NCT02242188` - Supplementing Iron and Development in Breastfed Infants (SIDBI Study)	Phase 4
Completed	`NCT02714361` - A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women	N/A
Completed	`NCT02176759` - Iron Absorption From Rice Fortified With Ferric Pyrophosphate	N/A
Completed	`NCT01922479` - Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure	Phase 4
Completed	`NCT01991626` - Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From LNS Added to Complementary Foods	N/A
Completed	`NCT01687062` - Iron Absorption From Tef-injera in Women of Reproductive Age	N/A
Completed	`NCT01573013` - Iron Fortification Trail Using NaFeEDTA in Iron Deficient Lead-exposed Children	N/A
Completed	`NCT01191463` - The Efficacy of a Local Vitamin-C Rich Fruit (Guava) in Improving Iron Absorption From Mungbean Based Meals and Its Effect on Iron Status of Rural Indian Children (6-10 Years)	N/A
Completed	`NCT01443832` - Iron Absorption From Iron-fortified Fonio Porridge: a Stable Isotope Study	Phase 0
Completed	`NCT01061307` - An Efficacy Trial of Iron, Zinc and Vitamin A Fortified Rice in Children in Satun, Thailand	Phase 0
Not yet recruiting	`NCT00515918` - The Effect of Early Iron Deficiency on Developmental Brain and Behavior in Infants	N/A
Recruiting	`NCT00378469` - Study of the Effects of Muscular Activity on Iron Metabolism	N/A
Recruiting	`NCT05992116` - Iron Deficiency in Patients With Heart Failure and Reduced and Mildly Reduced Ejection Fraction
Completed	`NCT05262634` - Pregnancy Outcome in Women With an Iron Deficiency in the First Trimester
Completed	`NCT06080555` - Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency Anaemia	Phase 1
Completed	`NCT04602247` - Evaluation of Iron Bioavailability From Iron Chlorophyllin	N/A
Completed	`NCT02996786` - Effects of Danggui Buxue Tang on Blood Biochemical Parameters in Male Recreational Runners	N/A
Completed	`NCT02175888` - The Optimization of Bioavailability From Iron Supplements: Study 1	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Detection of β Thalassemia Carriers by Red Cell Parameters Obtained From the H2 Automatic Counter

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms