NCT03919812: ThalTB

Immunomodulatory Vitamin D in Thalassemia

Completed NA Last updated 19 April 2019

What this trial tests

NA trial testing Cholecalciferol supplementation in Thalassemia in 60 participants. Completed in 15 August 2018.

Timeline

1 April 2018

Primary endpoint
15 July 2018

15 August 2018

Quick facts

Lead sponsor	Universitas Padjadjaran
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 April 2018
Primary completion	15 July 2018
Estimated completion	15 August 2018
Sites	1 location across Indonesia

Drugs / interventions tested

• Cholecalciferol supplementation

Conditions studied

• Thalassemia — all drugs for Thalassemia →
• Tuberculosis — all drugs for Tuberculosis →
• Vitamin D Deficiency — all drugs for Vitamin D Deficiency →

Sponsor

Universitas Padjadjaran — full company profile →

Who can join

Adults 1 to 17, any sex, with Thalassemia or Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Thalassemia becomes one of global health issue and so does Indonesia. In 2015, more than 7600 children were diagnosed as this hemoglobin genetic disease wherein anemia and lifetime blood transfusion contribute to their morbidity and mortality in Indonesia. Major β-Thalassemia is the most common type found. However, along with disease progression and age, iron accumulation and dysregulation becomes the most common complication exist. In cellular level, this condition results in cell and tissue damage especially immune cells and promotes favor condition for siderophilic bacteria such as Mycobaterium tuberculosis (Mtb) to growth rapidly. Severe infection becomes the second most cause of death in thalassemia-β major patients.

Tuberculosis (Tb) remains the global health issue especially in developing countries. Based on World Health Organization (WHO) report on 2015, Indonesia is the second highest burden of TB in the world. Both of adaptive and innate immune system plays important role in Mtb recognition and eradication. However, immune cells mechanism and activity in response to Mtb infection during iron accumulation condition on thalassemia-β major patients may be altered therefore need for further study. Macrophage is an adaptive immune cell, has a pivotal role on circulating-iron regulation and serves as Mtb host cell. To understand macrophage activity on thalassemia-β major patients can be studied by monocyte characteristic stimulated by Mtb antigen and evaluated by its differentiation into three subsets based on CD14 and CD16. Mtb antigen presentation is identified by HLA-DR expression on monocyte membrane.

Vitamin D is one of the most affected micronutrients on major β-thalassemia patients, yet it has immunomodulatory effect on immune system. Recent finding of vitamin D receptor (VDR) expressed in monocyte strongly convince that vitamin D should be maintained in major β-thalassemia patients where it is found lower in these patients. Thus, this original and true report aimed to declare that the research activity has finished and the data has been elaborated. Future plan is developing the original article based on the research finding corroborating the previous knowledge and innovative suggestion for the quality of thalassemia.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Nuclear receptors in health and disease: signaling pathways, biological functions and pharmaceutical interventions.
   Jin P, Duan X, Huang Z, Dong Y, et al · · 2025 · cited 21× · PMID 40717128 · DOI 10.1038/s41392-025-02270-3