The Role of Vitamin D, A, and Beta Carotene in Tuberculosis Patients With Vitamin D Receptor Gene Polymorphism

Study Overview
=================
Brief Summary
-----------------
Recent studies showed that vitamin D and A has an effect in improving sputum conversion in tuberculosis. This study aims to find out the effect of vitamin D 1000 IU and A 6000 IU supplementation on Tuberculosis patients with vitamin D receptor gene polymorphism, who live in North Sumatera, Indonesia. This study is a randomized control clinical trial, with 48 tuberculosis patients with vitamin D receptor gene polymorphism which are TaqI and FokI participating, divided into two groups, each with 24 participants, which are treatment group (I) which receives nutritional counseling, vitamin D 1000 IU, vitamin A 6000 IU, and control group (C) which only receives nutritional counseling for 28 days. Patients who participated was found to be heterozygous with TaqI (T>C) or FokI (C>T) genotype variants.

Detailed Description
-----------------
Recent studies showed that vitamin D and A has an effect in improving sputum conversion in tuberculosis. This study aims to find out the effect of vitamin D 1000 IU and A 6000 IU supplementation on Tuberculosis patients with vitamin D receptor gene polymorphism, who live in North Sumatera, Indonesia. This study is a randomized control clinical trial, with 48 tuberculosis patients with vitamin D receptor gene polymorphism which are TaqI and FokI participating, divided into two groups, each with 24 participants, which are treatment group (I) which receives nutritional counseling, vitamin D 1000 IU, vitamin A 6000 IU, and control group (C) which only receives nutritional counseling for 28 days. Patients who participated was found to be heterozygous with TaqI (T>C) or FokI (C>T) genotype variants. The result of this study showed that at the start, serum 25(OH)D levels in group I were lower compared to group C (19.746.59 ng/mL vs 25.21±7.57 ng/mL). Group I showed significant correlation between vitamin D level categories with sputum conversion (mean: standard deviation= 2.25±0.68 weeks). Supplementation of vitamin D 1000 IU provides an accelerated sputum conversion in tuberculosis patients with vitamin D receptor gene polymorphism.

Official Title
-----------------
The Role of Vitamin D, A, and Beta Carotene in Tuberculosis Patients With Vitamin D Receptor Gene Polymorphism

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Dietary Supplement: vitamin D 1000 IU and A 6000 IU supplementation and nutritional counseling
* Other: nutritional Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inclusion criteria are males or females, which have new case lung tuberculosis infection with acid fast bacilli (AFB) result (+), aged 18-60 years, heterozygote genotype test on one of the genes TaqI and FokI, willing to participate in the study and complete the informed consent. Exclusion Criteria: The exclusion criteria are pregnant, found to have comorbidities such as diabetes mellitus or Human Immunodeficiency Virus (+), and Tuberculosis on category II.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment Group<br>24 participants, which are treatment group (I) which receives nutritional counseling, vitamin D 1000 IU, vitamin A 6000 IU | Dietary Supplement: vitamin D 1000 IU and A 6000 IU supplementation and nutritional counseling<br>* 24 participants, which are treatment group (I) which receives nutritional counseling, vitamin D 1000 IU, vitamin A 6000 IU<br>|
| Active Comparator: Counseling Group<br>24 participants which only receives nutritional counseling for 28 days | Other: nutritional Counseling<br>* control group (C) which only receives nutritional counseling for 28 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vitamin D | 25(OH)D serum level | up to 4 weeks | 
| vitamin A | vitamin A serum level | up to 4 weeks | 
| beta carotene | beta carotene | up to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
25(OH)D serum, calcium, counseling, FokI, retinol, TaqI