Ignite Creation Date:
2024-05-06 @ 1:02 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03919812
Status:
COMPLETED
Last Update Posted:
2019-04-19
First Post:
2019-04-15
Brief Title:
Immunomodulatory Vitamin D in Thalassemia
Sponsor:
Universitas Padjadjaran
Organization:
Universitas Padjadjaran
Study Overview
Official Title:
Immunomodulatory Effect of Vitamin D Supplementation on Monocyte in Major Beta-thalassemia
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ThalTB
Brief Summary:
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
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
Detailed Description:
This study was designed as a non-randomized open label intervention study and performed at the thalassemia clinic of the Hasan Sadikin General Hospital Bandung West Java Indonesia Vitamin D deficiency in the general population is common in Indonesia with a prevalence of 41 reported in one study1 Sixty children aged 1 month to 15 years diagnosed as major β-thalassemia confirmed by clinical and hemoglobin electrophoresis who regularly having blood transfusion at least once in a month controlled in the clinic from March - May 2018 were recruited prospectively In addition children who had ferritin serum 1000 µgL in the last three months were met criteria for enrollment Children who had tuberculosis or co-infection hepatitis B hepatitis C and cytomegalovirus and sign of acute infection were not eligible for enrollment Informed consent was obtained from parents or childs guardian Vitamin D levels were measured before and after supplementation while identifying their vitamin D sufficiency status Classification of vitamin D sufficiency were used according to The Endocrine Society Clinical Practice Guideline which stated that the level of 25OHD of 20 ngml was considered to be vitamin D deficiency whereas a 25OHD of 21-29 ngml was considered to be insufficient Then a sufficient vitamin D was considered when the concentration of 25OHD was 30 ngmL or above2 No healthy control was enrolled to test for variability in the laboratory tests over time in this study
The intervention provided according to the participants state of vitamin D sufficiency vitamin D sufficient participants received 800 IU cholecalciferol syrup containing 400 IU cholecalciferol per measuring spoon Gracia Pharmindo Indonesia daily for 8 weeks while those who had insufficient or deficient vitamin D level consumed 2000 IU daily Compliance was systematically monitored using drug monitoring diary evaluated by researchers Blood samples for the study objectives were taken at enrollment and after eight weeks of cholecalciferol supplementation during routinely scheduled visits to the clinic 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
All procedures were conducted in accordance with policies of the Faculty of Medicine Universitas Padjadjaran and Hasan Sadikin General Hospital Bandung West Java Indonesia This study was approved by Health Research Ethics Committee of Medical Faculty Universitas Padjadjaran Bandung with approval number 50UN6KEPEC2018 All participants signed a written informed consent All participants signed a written informed consent This study was registered in clinicaltrialgov
The intervention provided according to the participants state of vitamin D sufficiency vitamin D sufficient participants received 800 IU cholecalciferol syrup containing 400 IU cholecalciferol per measuring spoon Gracia Pharmindo Indonesia daily for 8 weeks while those who had insufficient or deficient vitamin D level consumed 2000 IU daily Compliance was systematically monitored using drug monitoring diary evaluated by researchers Blood samples for the study objectives were taken at enrollment and after eight weeks of cholecalciferol supplementation during routinely scheduled visits to the clinic 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
All procedures were conducted in accordance with policies of the Faculty of Medicine Universitas Padjadjaran and Hasan Sadikin General Hospital Bandung West Java Indonesia This study was approved by Health Research Ethics Committee of Medical Faculty Universitas Padjadjaran Bandung with approval number 50UN6KEPEC2018 All participants signed a written informed consent All participants signed a written informed consent This study was registered in clinicaltrialgov
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None