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

Universitas Sumatera Utara

Status: Completed

Conditions: Tuberculosis

Treatments: Other: nutritional Counseling; Dietary Supplement: vitamin D 1000 IU and A 6000 IU supplementation and nutritional counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT04593524

USU 2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Treatment Group

Active Comparator group

Description:

24 participants, which are treatment group (I) which receives nutritional counseling, vitamin D 1000 IU, vitamin A 6000 IU

Treatment:

Dietary Supplement: vitamin D 1000 IU and A 6000 IU supplementation and nutritional counseling

Counseling Group

Active Comparator group

Description:

24 participants which only receives nutritional counseling for 28 days

Treatment:

Other: nutritional Counseling