Randomized controlled trial2017

Cholecalciferol for prophylaxis against antituberculosis therapy-induced liver disorders among naïve patients with pulmonary tuberculosis: A randomized, comparative study

Hasanain AFA, Zayed AAH, Mahdy RE, Nafee AMA

International journal of mycobacteriology · 11 citations

Review labels

Funding not disclosed

Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.

How it was studied

Design
Randomized controlled trial (indexed by PubMed)
Studied in
People
Main outcome
Clinical events such as disease or death

Who paid for it

Funding
Funding not disclosed

Publication

Published
2017-01-01 · Int J Mycobacteriol · vol. 6 · issue 2 · p. 149
Publisher
Elsevier BV
Cited
13 citations · more than 78% of similar papers · 1.1× the field average
References
35 works
Access
Open access (free to publish) · CC-BY-NC-SA
Research areas
Drug-Induced Hepatotoxicity and Protection · Tuberculosis Research and Epidemiology · Hepatitis C virus research
Keywords
Medicine, Internal medicine, Gastroenterology, Incidence (geometry), Adverse effect, Tuberculosis, Cholecalciferol, vitamin D deficiency, Population, Vitamin D and neurology, Pathology
MeSH
liver, humans, tuberculosis, pulmonary, cholecalciferol, antitubercular agents, prospective studies, adult, middle aged, female, male, young adult, chemical and drug induced liver injury

4 authors

From EG

  • AhmadFarooq Alsayed Hasanain · correspondingAssiut University
  • AliAbdel-Azeem Hasan ZayedAssiut University
  • ReemEzzat MahdyAssiut University
  • AmanyMohamed Adawi NafeeAssiut University

Abstract

Background

Patients in countries endemic for chronic viral hepatitis are more vulnerable to antituberculosis therapy-induced liver disorders (ATT-LDs). The aim of this study was to explore the role of cholecalciferol in prophylaxis against ATT-LD among patients with pulmonary tuberculosis (TB) receiving ATT.

Material and methods

We conducted a hospital-based, prospective, randomized, comparative study which included 300 consecutive, naïve patients with pulmonary TB eligible for ATT. The patients were randomly allocated to Group A (150 patients who received ATT) and Group B (150 patients who received ATT with cholecalciferol) who had clinical evaluation, laboratory investigations, and imaging studies. Statistical analysis used student's t-test and Chi-square test were used as appropriate to compare the variables between the study groups.

Results

The study population mean age was 35.6 ± 15.3 years. The overall incidence rate of ATT-LD among the study population was 9.3%; the incidence rate was significantly higher among Group A patients compared to those of Group B (13.3 vs. 5.3%;P = 0.001). The onset of ATT-LD was significantly earlier among patients of Group A compared to those of Group B (31.4 vs. 58.7 days,P = 0.027), while the duration of ATT-LD was significantly longer among patients of Group A compared to those of Group B (34.8 vs. 16.9 days,P = 0.009). No adverse effects related to cholecalciferol use were observed.

Conclusions

Adjuvant cholecalciferol supplementation may be protective against ATT-LD without extra adverse effects. Before recommending the routine use of cholecalciferol supplementation for prevention of ATT-LD, larger scale studies are recommended.

Abstract via Europe PMC. Copyright remains with the authors or publisher.

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