Immunomodulatory Vitamin D in Thalassemia

NCT03919812 | Completed

• 1 other identifier: TB-201804.01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Thalassemia; Tuberculosis; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Vitamin D supplementation according to baseline Vitamin D

EXPERIMENTAL

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.

Dietary Supplement: Cholecalciferol supplementation

Interventions

Cholecalciferol supplementation DIETARY_SUPPLEMENT

supplementation received by subject according to their vitamin D status: insufficiency or deficiency.

Vitamin D supplementation according to baseline Vitamin D

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children (aged 1 month to 15 years) diagnosed as major β-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

You may not qualify if:

• Children who had co-infection (hepatitis B, hepatitis C, and cytomegalovirus) and sign of acute infection were not eligible for enrollment.

Sponsors & Collaborators

• Universitas Padjadjaran: lead
• Hasan Sadikin General Hospital: collaborator

Study Sites (1)

Klinik Thalassemia Rumah Sakit Dr. Hasan Sadikin Bandung

Bandung, West Java, 40161, Indonesia

Location

MeSH Terms

Conditions

Thalassemia; Tuberculosis; Vitamin D Deficiency

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; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Mohammad Ghozali, Dr.

  Faculty of Medicine Universitas Padjadjaran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 18, 2019
• Study Start: April 1, 2018
• Primary Completion: July 15, 2018
• Study Completion: August 15, 2018
• Last Updated: April 19, 2019

Record last verified: 2019-04

Locations

ID (1)