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NCT03851055

Zinc Supplementation in Patients With β-Thalassemia Major Complicated With Diabetes Mellitus

Completed Phase 3 Last updated 25 February 2019
What this trial tests

Phase 3 trial testing Zinc in Beta-thalassemia Major Complicated With Diabetes in 80 participants. Completed in 28 August 2018.

Timeline
1 August 2017
Primary endpoint
10 July 2018
28 August 2018

Quick facts

Lead sponsorAin Shams University
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment80
Start date1 August 2017
Primary completion10 July 2018
Estimated completion28 August 2018
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Ain Shams University

Who can join

Adults 10 to 18, any sex, with Beta-thalassemia Major Complicated With Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Beta-thalassemia represents a group of recessive inherited hemoglobin disorders characterized by reduced synthesis of β-globin chain. The homozygous state (β-thalassemia major) "TM" results in severe anemia, which needs regular blood transfusion . The life expectancy in patients with TM has increased due to therapeutically management, such as frequent transfusion, desferal administration and bone marrow transplantation. Diabetes is clinically characterized by hyperglycemia due to either low circulating concentrations of, or decreased sensitivity to, insulin. Patients with TM typically exhibit β-cell or insulin insufficiency, and may develop diabetes due to toxic levels of iron in their pancreas, one of the strongest predictors of β-cell destruction. By contrast, hyperinsulinemia, secondary to insulin resistance, with normal glucose tolerance has also been observed. The pathogenic mechanisms leading from siderosis to diabetes are poorly understood.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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