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

NCT03851055 | Completed Phase 3

• 1 other identifier: Ain shams Pediatrics 3082019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Beta-thalassemia Major Complicated With Diabetes

Keywords

Zinc; blood glucose; diabetes; beta thalassemia

Outcome Measures

Primary Outcomes (1)

• Fasting blood glucose mg/dl

  the change in fasting blood glucose level after the 12 weeks of treatment in the intervention group when compared to the placebo group.

  12 weeks

Secondary Outcomes (2)

• HbA1c%

  12 weeks

• fructosamine mg/dl

  12 weeks

Study Arms (2)

intervention group

ACTIVE COMPARATOR

will receive zinc supplementation

Drug: Zinc

Control group

NO INTERVENTION

Patients will receive placebo only

Interventions

Zinc DRUG

One arm will receive Zinc Second arm will receive placebo

intervention group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with β-thalassemia major and diabetes confirmed by history, examination and investigation.
• Patients on regular visits to clinic.
• Age more than 10 years old.

You may not qualify if:

• Those who refused to lay informed consent.
• Those below age limit.
• Patients with other disorders that may affect glucose homeostasis rather than TM.
• Patients with autoimmune disease, collagen diseases, infections, tumors, hematological diseases other than Thalassemia major.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Nancy Elbarbary

Cairo, 11361, Egypt

Location

Related Publications (3)

• Gamberini MR, Fortini M, De Sanctis V, Gilli G, Testa MR. Diabetes mellitus and impaired glucose tolerance in thalassaemia major: incidence, prevalence, risk factors and survival in patients followed in the Ferrara Center. Pediatr Endocrinol Rev. 2004 Dec;2 Suppl 2:285-91.

  PMID: 16462713 BACKGROUND

• Capdor J, Foster M, Petocz P, Samman S. Zinc and glycemic control: a meta-analysis of randomised placebo controlled supplementation trials in humans. J Trace Elem Med Biol. 2013 Apr;27(2):137-42. doi: 10.1016/j.jtemb.2012.08.001. Epub 2012 Nov 6.

  PMID: 23137858 BACKGROUND

• Fung EB, Kwiatkowski JL, Huang JN, Gildengorin G, King JC, Vichinsky EP. Zinc supplementation improves bone density in patients with thalassemia: a double-blind, randomized, placebo-controlled trial. Am J Clin Nutr. 2013 Oct;98(4):960-71. doi: 10.3945/ajcn.112.049221. Epub 2013 Aug 14.

  PMID: 23945720 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; beta-Thalassemia

Interventions

Zinc

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 22, 2019
• Study Start: August 1, 2017
• Primary Completion: July 10, 2018
• Study Completion: August 28, 2018
• Last Updated: February 25, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)