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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Effect of High-Dose vs Standard-Dose Multivitamin Supplementation at the Initiation of HAART on HIV Disease Progression and Mortality in Tanzania</title><author><name sortKey="Isanaka, Sheila" sort="Isanaka, Sheila" uniqKey="Isanaka S" first="Sheila" last="Isanaka">Sheila Isanaka</name></author><author><name sortKey="Mugusi, Ferdinand" sort="Mugusi, Ferdinand" uniqKey="Mugusi F" first="Ferdinand" last="Mugusi">Ferdinand Mugusi</name></author><author><name sortKey="Hawkins, Claudia" sort="Hawkins, Claudia" uniqKey="Hawkins C" first="Claudia" last="Hawkins">Claudia Hawkins</name></author><author><name sortKey="Spiegelman, Donna" sort="Spiegelman, Donna" uniqKey="Spiegelman D" first="Donna" last="Spiegelman">Donna Spiegelman</name></author><author><name sortKey="Okuma, James" sort="Okuma, James" uniqKey="Okuma J" first="James" last="Okuma">James Okuma</name></author><author><name sortKey="Aboud, Said" sort="Aboud, Said" uniqKey="Aboud S" first="Said" last="Aboud">Said Aboud</name></author><author><name sortKey="Guerino, Chalamilla" sort="Guerino, Chalamilla" uniqKey="Guerino C" first="Chalamilla" last="Guerino">Chalamilla Guerino</name></author><author><name sortKey="Fawzi, Wafaie W" sort="Fawzi, Wafaie W" uniqKey="Fawzi W" first="Wafaie W." last="Fawzi">Wafaie W. Fawzi</name></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">23073950</idno><idno type="pmc">3811009</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3811009</idno><idno type="RBID">PMC:3811009</idno><idno type="doi">10.1001/jama.2012.13083</idno><date when="2012">2012</date><idno type="wicri:Area/Pmc/Corpus">001B54</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001B54</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Effect of High-Dose vs Standard-Dose Multivitamin Supplementation at the Initiation of HAART on HIV Disease Progression and Mortality in Tanzania</title><author><name sortKey="Isanaka, Sheila" sort="Isanaka, Sheila" uniqKey="Isanaka S" first="Sheila" last="Isanaka">Sheila Isanaka</name></author><author><name sortKey="Mugusi, Ferdinand" sort="Mugusi, Ferdinand" uniqKey="Mugusi F" first="Ferdinand" last="Mugusi">Ferdinand Mugusi</name></author><author><name sortKey="Hawkins, Claudia" sort="Hawkins, Claudia" uniqKey="Hawkins C" first="Claudia" last="Hawkins">Claudia Hawkins</name></author><author><name sortKey="Spiegelman, Donna" sort="Spiegelman, Donna" uniqKey="Spiegelman D" first="Donna" last="Spiegelman">Donna Spiegelman</name></author><author><name sortKey="Okuma, James" sort="Okuma, James" uniqKey="Okuma J" first="James" last="Okuma">James Okuma</name></author><author><name sortKey="Aboud, Said" sort="Aboud, Said" uniqKey="Aboud S" first="Said" last="Aboud">Said Aboud</name></author><author><name sortKey="Guerino, Chalamilla" sort="Guerino, Chalamilla" uniqKey="Guerino C" first="Chalamilla" last="Guerino">Chalamilla Guerino</name></author><author><name sortKey="Fawzi, Wafaie W" sort="Fawzi, Wafaie W" uniqKey="Fawzi W" first="Wafaie W." last="Fawzi">Wafaie W. Fawzi</name></author></analytic><series><title level="j">JAMA : the journal of the American Medical Association</title><idno type="ISSN">0098-7484</idno><idno type="eISSN">1538-3598</idno><imprint><date when="2012">2012</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>Context</title><p id="P1">Large randomized trials have previously shown that high-dose micronutrient supplementation can increase CD4 counts and reduce human immunodeficiency virus (HIV) disease progression and mortality among individuals not receiving highly active antiretroviral therapy (HAART); however, the safety and efficacy of such supplementation has not been established in the context of HAART.</p></sec><sec id="S2"><title>Objective</title><p id="P2">To test the hypothesis that high-dose multivitamin supplementation vs standard-dose multivitamin supplementation decreases the risk of HIV disease progression or death and improves immunological, virological, and nutritional parameters in patients with HIV initiating HAART.</p></sec><sec id="S3"><title>Design, Setting, and Participants</title><p id="P3">A randomized, double-blind, controlled trial of high-dose vs standard-dose multivitamin supplementation for 24 months in 3418 patients with HIV initiating HAART between November 2006 and November 2008 in 7 clinics in Dar es Salaam, Tanzania.</p></sec><sec id="S4"><title>Intervention</title><p id="P4">The provision of daily oral supplements of vitamin B complex, vitamin C, and vitamin E at high levels or standard levels of the recommended dietary allowance.</p></sec><sec id="S5"><title>Main Outcome Measure</title><p id="P5">The composite of HIV disease progression or death from any cause.</p></sec><sec id="S6"><title>Results</title><p id="P6">The study was stopped early in March 2009 because of evidence of increased levels of alanine transaminase (ALT) in patients receiving the high-dose multivitamin supplement. At the time of stopping, 3418 patients were enrolled (median follow-up, 15 months), and there were 2374 HIV disease progression events and 453 observed deaths (2460 total combined events). Compared with standard-dose multivitamin supplementation, high-dose supplementation did not reduce the risk of HIV disease progression or death. The absolute risk of HIV progression or death was 72% in the high-dose group vs 72% in the standard-dose group (risk ratio [RR], 1.00; 95% CI, 0.96–1.04). High-dose supplementation had no effect on CD4 count, plasma viral load, body mass index, or hemoglobin level concentration, but increased the risk of ALT elevations (1239 events per 1215 person-years vs 879 events per 1236 person-years; RR, 1.44; 95% CI, 1.11–1.87) vs standard-dose supplementation.</p></sec><sec id="S7"><title>Conclusion</title><p id="P7">In adults receiving HAART, use of high-dose multivitamin supplements compared with standard-dose multivitamin supplements did not result in a decrease in HIV disease progression or death but may have resulted in an increase in ALT levels.</p></sec><sec id="S8"><title>Trial Registration</title><p id="P8">clinicaltrials.gov Identifier: NCT00383669</p></sec></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">7501160</journal-id><journal-id journal-id-type="pubmed-jr-id">5346</journal-id><journal-id journal-id-type="nlm-ta">JAMA</journal-id><journal-id journal-id-type="iso-abbrev">JAMA</journal-id><journal-title-group><journal-title>JAMA : the journal of the American Medical Association</journal-title></journal-title-group><issn pub-type="ppub">0098-7484</issn><issn pub-type="epub">1538-3598</issn></journal-meta><article-meta><article-id pub-id-type="pmid">23073950</article-id><article-id pub-id-type="pmc">3811009</article-id><article-id pub-id-type="doi">10.1001/jama.2012.13083</article-id><article-id pub-id-type="manuscript">NIHMS508598</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Effect of High-Dose vs Standard-Dose Multivitamin Supplementation at the Initiation of HAART on HIV Disease Progression and Mortality in Tanzania</article-title><subtitle>A Randomized Controlled Trial</subtitle></title-group><contrib-group><contrib contrib-type="author"><name><surname>Isanaka</surname><given-names>Sheila</given-names><prefix>Dr.</prefix></name><degrees>ScD</degrees></contrib><contrib contrib-type="author"><name><surname>Mugusi</surname><given-names>Ferdinand</given-names><prefix>Dr.</prefix></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Hawkins</surname><given-names>Claudia</given-names><prefix>Dr.</prefix></name><degrees>MD, MPH</degrees></contrib><contrib contrib-type="author"><name><surname>Spiegelman</surname><given-names>Donna</given-names><prefix>Dr.</prefix></name><degrees>ScD</degrees></contrib><contrib contrib-type="author"><name><surname>Okuma</surname><given-names>James</given-names><prefix>Mr.</prefix></name><degrees>MS</degrees></contrib><contrib contrib-type="author"><name><surname>Aboud</surname><given-names>Said</given-names><prefix>Dr.</prefix></name><degrees>MD</degrees></contrib><contrib contrib-type="author"><name><surname>Guerino</surname><given-names>Chalamilla</given-names><prefix>Dr.</prefix></name><degrees>MD, PhD</degrees></contrib><contrib contrib-type="author"><name><surname>Fawzi</surname><given-names>Wafaie W.</given-names><prefix>Dr.</prefix></name><degrees>MBBS, DrPH</degrees></contrib><aff id="A1">Departments of Nutrition (Drs Isanaka, Guerino, and Fawzi and Mr Okuma), Epidemiology (Drs Spiegelman and Fawzi), Biostatistics (Dr Spiegelman), and Global Health and Population (Dr Fawzi); Harvard School of Public Health, Boston, Massachusetts; Departments of Microbiology and Immunology (Dr Aboud) and Internal Medicine (Dr Mugusi), Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania; Center for Global Health, Northwestern University Feinberg School of Medicine, Chicago, Illinois (Dr Hawkins); and Management and Development for Health, Dar es Salaam, Tanzania (Dr Guerino)</aff></contrib-group><author-notes><corresp id="FN1">Corresponding Author: Sheila Isanaka, ScD, Department of Nutrition, Harvard School of Public Health, 665 Huntington Ave, Boston, MA 02115 (<email>sisanaka@hsph.harvard.edu</email>)</corresp></author-notes><pub-date pub-type="nihms-submitted"><day>21</day><month>10</month><year>2013</year></pub-date><pub-date pub-type="ppub"><day>17</day><month>10</month><year>2012</year></pub-date><pub-date pub-type="pmc-release"><day>29</day><month>10</month><year>2013</year></pub-date><volume>308</volume><issue>15</issue><elocation-id>10.1001/jama.2012.13083</elocation-id><permissions><copyright-statement>© 2012 American Medical Association. All rights reserved.</copyright-statement><copyright-year>2012</copyright-year></permissions><abstract><sec id="S1"><title>Context</title><p id="P1">Large randomized trials have previously shown that high-dose micronutrient supplementation can increase CD4 counts and reduce human immunodeficiency virus (HIV) disease progression and mortality among individuals not receiving highly active antiretroviral therapy (HAART); however, the safety and efficacy of such supplementation has not been established in the context of HAART.</p></sec><sec id="S2"><title>Objective</title><p id="P2">To test the hypothesis that high-dose multivitamin supplementation vs standard-dose multivitamin supplementation decreases the risk of HIV disease progression or death and improves immunological, virological, and nutritional parameters in patients with HIV initiating HAART.</p></sec><sec id="S3"><title>Design, Setting, and Participants</title><p id="P3">A randomized, double-blind, controlled trial of high-dose vs standard-dose multivitamin supplementation for 24 months in 3418 patients with HIV initiating HAART between November 2006 and November 2008 in 7 clinics in Dar es Salaam, Tanzania.</p></sec><sec id="S4"><title>Intervention</title><p id="P4">The provision of daily oral supplements of vitamin B complex, vitamin C, and vitamin E at high levels or standard levels of the recommended dietary allowance.</p></sec><sec id="S5"><title>Main Outcome Measure</title><p id="P5">The composite of HIV disease progression or death from any cause.</p></sec><sec id="S6"><title>Results</title><p id="P6">The study was stopped early in March 2009 because of evidence of increased levels of alanine transaminase (ALT) in patients receiving the high-dose multivitamin supplement. At the time of stopping, 3418 patients were enrolled (median follow-up, 15 months), and there were 2374 HIV disease progression events and 453 observed deaths (2460 total combined events). Compared with standard-dose multivitamin supplementation, high-dose supplementation did not reduce the risk of HIV disease progression or death. The absolute risk of HIV progression or death was 72% in the high-dose group vs 72% in the standard-dose group (risk ratio [RR], 1.00; 95% CI, 0.96–1.04). High-dose supplementation had no effect on CD4 count, plasma viral load, body mass index, or hemoglobin level concentration, but increased the risk of ALT elevations (1239 events per 1215 person-years vs 879 events per 1236 person-years; RR, 1.44; 95% CI, 1.11–1.87) vs standard-dose supplementation.</p></sec><sec id="S7"><title>Conclusion</title><p id="P7">In adults receiving HAART, use of high-dose multivitamin supplements compared with standard-dose multivitamin supplements did not result in a decrease in HIV disease progression or death but may have resulted in an increase in ALT levels.</p></sec><sec id="S8"><title>Trial Registration</title><p id="P8">clinicaltrials.gov Identifier: NCT00383669</p></sec></abstract><funding-group><award-group><funding-source country="United States">National Institute of Child Health & Human Development : NICHD</funding-source><award-id>R01 HD032257 || HD</award-id></award-group></funding-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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