Tuberculosis Clinical Trial
— ThalTBOfficial title:
Immunomodulatory Effect of Vitamin D Supplementation on Monocyte in Major Beta-thalassemia
Verified date | April 2019 |
Source | Universitas Padjadjaran |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | August 15, 2018 |
Est. primary completion date | July 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 17 Years |
Eligibility |
Inclusion Criteria: - Children (aged 1 month to 15 years) diagnosed as major ß-thalassemia - Regularly having blood transfusion at least once in a month - controlled in Thalassemia Polyclinic of Hasan Sadikin General Hospital Bandung, West Java, - had ferritin serum >1000 µg/L in the last three months Exclusion Criteria: - Children who had co-infection (hepatitis B, hepatitis C, and cytomegalovirus) and sign of acute infection were not eligible for enrollment. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Klinik Thalassemia Rumah Sakit Dr. Hasan Sadikin Bandung | Bandung | West Java |
Lead Sponsor | Collaborator |
---|---|
Universitas Padjadjaran | Hasan Sadikin General Hospital |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The outcome measure was the change in the proportion of monocyte subsets | The outcome measure was the change in the proportion of monocyte subsets and the expression of membrane-bound protein of monocyte consist of CD14, CD16, and HLA-DR. | Eight-week supplementation |
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