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High-dose vitamin D3 in adults with pulmonary tuberculosis: a double-blind randomized controlled trial.
Am J Clin Nutr 2015; 102(5):1059-69AJ

Abstract

BACKGROUND

Tuberculosis, including multidrug-resistant tuberculosis (MDR-TB), is a major global health problem. Individuals with tuberculosis disease commonly exhibit vitamin D deficiency, which may adversely affect immunity and the response to therapy.

OBJECTIVE

We determined whether adjunctive high-dose vitamin D3 supplementation improves outcomes in individuals with pulmonary tuberculosis disease.

DESIGN

The study was a double-blind, randomized, placebo-controlled, intent-to-treat trial in 199 individuals with pulmonary tuberculosis disease in Tbilisi, Georgia. Subjects were randomly assigned to receive oral vitamin D3 [50,000 IUs (1.25 mg) thrice weekly for 8 wk and 50,000 IU every other week for 8 wk] or a placebo concomitant with standard first-line antituberculosis drugs. The primary outcome was the time for the conversion of a Mycobacterium tuberculosis (Mtb) sputum culture to negative.

RESULTS

Baseline characteristics between groups were similar. Most subjects (74%) were vitamin D deficient (plasma 25-hydroxyvitamin D [25(OH)D] concentration <50 nmol/L). With vitamin D3, plasma 25(OH)D concentrations peaked at ∼250 nmol/L by 8 wk and decreased to ∼125 nmol/L at week 16. Adverse events and plasma calcium concentrations were similar between groups. In 192 subjects with culture-confirmed tuberculosis, an adjusted efficacy analysis showed similar median culture-conversion times between vitamin D3 and placebo groups [29 and 27 d, respectively; HR: 0.86; 95% CI: 0.63, 1.18; P = 0.33). Eight-week culture-conversion rates were also similar (84.0% and 82.1% for vitamin D3 and placebo, respectively; P = 0.99).

CONCLUSION

A high-dose vitamin D3 regimen safely corrected vitamin D deficiency but did not improve the rate of sputum Mtb clearance over 16 wk in this pulmonary tuberculosis cohort. This trial was registered at clinicaltrials.gov at NCT00918086.

Authors+Show Affiliations

National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia;National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia;National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia;Divisions of Endocrinology, Metabolism and Lipids and.Biostatistics and Bioinformatics and.Biostatistics and Bioinformatics and.Divisions of Endocrinology, Metabolism and Lipids and Infectious Diseases and.Divisions of Endocrinology, Metabolism and Lipids and Center for Clinical and Molecular Nutrition, Department of Medicine, Emory University School of Medicine, Atlanta, GA; Departments of.National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia; Divisions of Endocrinology, Metabolism and Lipids and.Divisions of Endocrinology, Metabolism and Lipids and Center for Clinical and Molecular Nutrition, Department of Medicine, Emory University School of Medicine, Atlanta, GA; Departments of.National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia;National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia;Divisions of Endocrinology, Metabolism and Lipids and.Infectious Diseases and Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA; and.Divisions of Endocrinology, Metabolism and Lipids and Center for Clinical and Molecular Nutrition, Department of Medicine, Emory University School of Medicine, Atlanta, GA; Departments of Atlanta Veterans Affairs Medical Center, Decatur, GA.Infectious Diseases and Epidemiology and.Divisions of Endocrinology, Metabolism and Lipids and Center for Clinical and Molecular Nutrition, Department of Medicine, Emory University School of Medicine, Atlanta, GA; Departments of tzieg01@emory.edu.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26399865

Citation

Tukvadze, Nestan, et al. "High-dose Vitamin D3 in Adults With Pulmonary Tuberculosis: a Double-blind Randomized Controlled Trial." The American Journal of Clinical Nutrition, vol. 102, no. 5, 2015, pp. 1059-69.
Tukvadze N, Sanikidze E, Kipiani M, et al. High-dose vitamin D3 in adults with pulmonary tuberculosis: a double-blind randomized controlled trial. Am J Clin Nutr. 2015;102(5):1059-69.
Tukvadze, N., Sanikidze, E., Kipiani, M., Hebbar, G., Easley, K. A., Shenvi, N., ... Ziegler, T. R. (2015). High-dose vitamin D3 in adults with pulmonary tuberculosis: a double-blind randomized controlled trial. The American Journal of Clinical Nutrition, 102(5), pp. 1059-69. doi:10.3945/ajcn.115.113886.
Tukvadze N, et al. High-dose Vitamin D3 in Adults With Pulmonary Tuberculosis: a Double-blind Randomized Controlled Trial. Am J Clin Nutr. 2015;102(5):1059-69. PubMed PMID: 26399865.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - High-dose vitamin D3 in adults with pulmonary tuberculosis: a double-blind randomized controlled trial. AU - Tukvadze,Nestan, AU - Sanikidze,Ekaterina, AU - Kipiani,Maia, AU - Hebbar,Gautam, AU - Easley,Kirk A, AU - Shenvi,Neeta, AU - Kempker,Russell R, AU - Frediani,Jennifer K, AU - Mirtskhulava,Veriko, AU - Alvarez,Jessica A, AU - Lomtadze,Nino, AU - Vashakidze,Lamara, AU - Hao,Li, AU - Del Rio,Carlos, AU - Tangpricha,Vin, AU - Blumberg,Henry M, AU - Ziegler,Thomas R, Y1 - 2015/09/23/ PY - 2015/04/30/received PY - 2015/08/20/accepted PY - 2015/9/25/entrez PY - 2015/9/25/pubmed PY - 2016/2/9/medline KW - Mycobacterium tuberculosis KW - multidrug-resistant tuberculosis KW - randomized controlled trial KW - tuberculosis KW - vitamin D SP - 1059 EP - 69 JF - The American journal of clinical nutrition JO - Am. J. Clin. Nutr. VL - 102 IS - 5 N2 - BACKGROUND: Tuberculosis, including multidrug-resistant tuberculosis (MDR-TB), is a major global health problem. Individuals with tuberculosis disease commonly exhibit vitamin D deficiency, which may adversely affect immunity and the response to therapy. OBJECTIVE: We determined whether adjunctive high-dose vitamin D3 supplementation improves outcomes in individuals with pulmonary tuberculosis disease. DESIGN: The study was a double-blind, randomized, placebo-controlled, intent-to-treat trial in 199 individuals with pulmonary tuberculosis disease in Tbilisi, Georgia. Subjects were randomly assigned to receive oral vitamin D3 [50,000 IUs (1.25 mg) thrice weekly for 8 wk and 50,000 IU every other week for 8 wk] or a placebo concomitant with standard first-line antituberculosis drugs. The primary outcome was the time for the conversion of a Mycobacterium tuberculosis (Mtb) sputum culture to negative. RESULTS: Baseline characteristics between groups were similar. Most subjects (74%) were vitamin D deficient (plasma 25-hydroxyvitamin D [25(OH)D] concentration <50 nmol/L). With vitamin D3, plasma 25(OH)D concentrations peaked at ∼250 nmol/L by 8 wk and decreased to ∼125 nmol/L at week 16. Adverse events and plasma calcium concentrations were similar between groups. In 192 subjects with culture-confirmed tuberculosis, an adjusted efficacy analysis showed similar median culture-conversion times between vitamin D3 and placebo groups [29 and 27 d, respectively; HR: 0.86; 95% CI: 0.63, 1.18; P = 0.33). Eight-week culture-conversion rates were also similar (84.0% and 82.1% for vitamin D3 and placebo, respectively; P = 0.99). CONCLUSION: A high-dose vitamin D3 regimen safely corrected vitamin D deficiency but did not improve the rate of sputum Mtb clearance over 16 wk in this pulmonary tuberculosis cohort. This trial was registered at clinicaltrials.gov at NCT00918086. SN - 1938-3207 UR - https://www.unboundmedicine.com/medline/citation/26399865/High_dose_vitamin_D3_in_adults_with_pulmonary_tuberculosis:_a_double_blind_randomized_controlled_trial_ L2 - https://academic.oup.com/ajcn/article-lookup/doi/10.3945/ajcn.115.113886 DB - PRIME DP - Unbound Medicine ER -