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NCT04593524 Clinical Trial

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

Tuberculosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04593524
Other study ID # USU 2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 14, 2019
Est. completion date September 22, 2019

Study information
Verified date October 2020
Source Universitas Sumatera Utara
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date September 22, 2019
Est. primary completion date August 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 60 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• vitamin D 1000 IU and A 6000 IU supplementation and nutritional counseling
24 participants, which are treatment group (I) which receives nutritional counseling, vitamin D 1000 IU, vitamin A 6000 IU
Other:
• nutritional Counseling
control group (C) which only receives nutritional counseling for 28 days

Locations
Country Name City State
Indonesia Faculty of Medicine Universitas Sumatera Utara Medan North Sumatra

Sponsors (1)
Lead Sponsor Collaborator
Universitas Sumatera Utara

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary vitamin D 25(OH)D serum level up to 4 weeks
Primary vitamin A vitamin A serum level up to 4 weeks
Primary beta carotene beta carotene up to 4 weeks
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