Zinc Supplementation on Cellular Immunity in Thalassemia Major

NCT03117192 | Completed Phase 4

• 1 other identifier: 02
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized controlled trial was conducted in post-splenectomy patients aged \>12 years. Subjects are randomly assigned to two groups (zinc and placebo). 1.5 mg/kg/day (max 50 mg/day) of Zinc is administered.

Conditions

Thalassemia; Splenectomy; Status; Immunosuppression

Keywords

zinc supplementation; immunity; thalassemia

Outcome Measures

Primary Outcomes (1)

• Patient's T-lymphocyte count

  Measurement of patients CD4+ and CD8+ T-lymphocyte count in uL

  12 weeks

Study Arms (2)

Zinc sulfate

EXPERIMENTAL

Zinc sulfate is provided in the form of syrup at a dose of 1.5 mg/kg/day, maximum 50 mg/day.

Drug: Zinc Sulfate

Sucrose syrup

PLACEBO COMPARATOR

Sucrose syrup is used as placebo, its provided in the form of syrup with similar appearance and taste.

Drug: Sucrose Syrup

Interventions

Zinc Sulfate DRUG

Zinc supplementation in syrup form

Zinc sulfate

Sucrose Syrup DRUG

Sucrose as placebo, with same taste and consistency as zinc

Sucrose syrup

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Thalassemia major patients
• Age \> 12 years
• Agreed to participate and signed the informed consent
• No other comorbidity beside thalassemia

You may not qualify if:

• HIV positive patients
• Those in steroid medication

Sponsors & Collaborators

• Fakultas Kedokteran Universitas Indonesia: lead

Study Sites (1)

Fakultas Kedokteran Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Conditions

Thalassemia

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

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)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Study Officials

• Teny T Sari, M.D., PhD

  Faculty of Medicine University of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Secretary to the department held an envelope that shows sample allocation after randomization. The envelope is only revealed after data gathering is finished.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This interventional study is a randomized controlled trial comparing the parallel provision of zinc and placebo in 2 groups of splenectomized thalassemia major patients.

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 17, 2017
• Study Start: September 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 17, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)