Effect of High-Dose vs Standard-Dose Multivitamin Supplementation at the Initiation of HAART on HIV Disease Progression and Mortality in Tanzania
Identifieur interne : 001B54 ( Pmc/Corpus ); précédent : 001B53; suivant : 001B55Effect of High-Dose vs Standard-Dose Multivitamin Supplementation at the Initiation of HAART on HIV Disease Progression and Mortality in Tanzania
Auteurs : Sheila Isanaka ; Ferdinand Mugusi ; Claudia Hawkins ; Donna Spiegelman ; James Okuma ; Said Aboud ; Chalamilla Guerino ; Wafaie W. FawziSource :
- JAMA : the journal of the American Medical Association [ 0098-7484 ] ; 2012.
Abstract
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.
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.
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.
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.
The composite of HIV disease progression or death from any cause.
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.
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.
clinicaltrials.gov Identifier: NCT00383669
Url:
DOI: 10.1001/jama.2012.13083
PubMed: 23073950
PubMed Central: 3811009
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PMC:3811009Le document en format XML
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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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