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

Not Applicable

Completed

• Conditions: Tuberculosis
• Interventions: Other: nutritional Counseling; Dietary Supplement: vitamin D 1000 IU and A 6000 IU supplementation and nutritional counseling

• Registration Number: NCT04593524
• Lead Sponsor: Universitas Sumatera Utara

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.

Study Timeline

• Study Start: 2019-05-14
• Primary Completion: 2019-08-15
• Study Completion: 2019-09-22
• Study First Submitted: 2020-09-29
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-13
• Last Update Submitted: 2020-10-13
• Study First Posted: 2020-10-20
• Last Update Posted: 2020-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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.

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Exclusion Criteria

• The exclusion criteria are pregnant, found to have comorbidities such as diabetes mellitus or Human Immunodeficiency Virus (+), and Tuberculosis on category II.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Counseling Group	nutritional Counseling	24 participants which only receives nutritional counseling for 28 days
Treatment Group	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

Primary Outcome Measures

Name	Time	Method
beta carotene	up to 4 weeks	beta carotene
vitamin A	up to 4 weeks	vitamin A serum level
vitamin D	up to 4 weeks	25(OH)D serum level

Trial Locations

Locations (1)

Faculty of Medicine Universitas Sumatera Utara; 🇮🇩 Medan, North Sumatra, Indonesia