Randomized, Controlled Clinical Trial of Zinc Supplementation to Prevent Immunological Failure in HIV-Infected Adults
Background. Adequate zinc is critical for immune function; however, zinc deficiency occurs in 150% of human immunodeficiency virus (HIV)-infected adults. We examined the safety and efficacy of long-term zinc supplementation in relation to HIV disease progression. Methods. A prospective, randomized,...
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description | Background. Adequate zinc is critical for immune function; however, zinc deficiency occurs in 150% of human immunodeficiency virus (HIV)-infected adults. We examined the safety and efficacy of long-term zinc supplementation in relation to HIV disease progression. Methods. A prospective, randomized, controlled clinical trial was conducted involving 231 HIV-infected adults with low plasma zinc levels ( |
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Bryan ; Campa, Adriana</creator><creatorcontrib>Baum, Marianna K. ; Lai, Shenghan ; Sales, Sabrina ; Page, J. Bryan ; Campa, Adriana</creatorcontrib><description>Background. Adequate zinc is critical for immune function; however, zinc deficiency occurs in 150% of human immunodeficiency virus (HIV)-infected adults. We examined the safety and efficacy of long-term zinc supplementation in relation to HIV disease progression. Methods. A prospective, randomized, controlled clinical trial was conducted involving 231 HIV-infected adults with low plasma zinc levels (<0.75 mg/L), who were randomly assigned to receive zinc (12 mg of elemental zinc for women and 15 mg for men) or placebo for 18 months. The primary end point was immunological failure. HIV viral load and CD4+ cell count were determined every 6 months. Questionnaires, pill counts, and plasma zinc and C-reactive protein levels were used to monitor adherence to study supplements and antiretroviral therapy. Intent-to-treat analysis used multiple-event analysis, treating CD4+ cell count <200 cells/mm3 as a recurrent immunological failure event. Cox proportional hazard models and the general-linear model were used to analyze morbidity and mortality data. Results. Zinc supplementation for 18 months reduced 4-fold the likelihood of immunological failure, controlling for age, sex, food insecurity, baseline CD4+ cell count, viral load, and antiretroviral therapy (relative rate, 0.24; 95% confidence interval, 0.10-0.56; P < .002). Viral load indicated poor control with antiretroviral therapy but was not affected by zinc supplementation. Zinc supplementation also reduced the rate of diarrhea by more than half (odds ratio, 0.4; 95% confidence interval, 0.183-0.981; Pp.019), compared with placebo. There was no significant difference in mortality between the 2 groups. Conclusions. This study demonstrated that long-term (18-month) zinc supplementation at nutritional levels delayed immunological failure and decreased diarrhea over time. This evidence supports the use of zinc supplementation as an adjunct therapy for HIV-infected adult cohorts with poor viral control. Trial registration. ClinicalTrials.gov identifier: NCT00149552.</description><identifier>ISSN: 1058-4838</identifier><identifier>EISSN: 1537-6591</identifier><identifier>DOI: 10.1086/652864</identifier><identifier>PMID: 20455705</identifier><identifier>CODEN: CIDIEL</identifier><language>eng</language><publisher>Oxford: The University of Chicago Press</publisher><subject>Adult ; Adults ; AIDS ; Arts ; Biological and medical sciences ; CD4 Lymphocyte Count ; Clinical medicine ; Diarrhea ; Dietary Supplements ; Disease Progression ; Female ; HIV ; HIV Infections - drug therapy ; HIV Infections - immunology ; HIV Infections - mortality ; HIV/AIDS ; Human immunodeficiency virus ; Human viral diseases ; Humans ; Immune System Diseases - prevention & control ; Immunodeficiencies ; Immunodeficiencies. Immunoglobulinopathies ; Immunology ; Immunopathology ; Infectious diseases ; Male ; Medical research ; Medical sciences ; Middle Aged ; Morbidity ; Mortality ; Placebos ; Treatment Outcome ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids ; Viral Load ; Zinc ; Zinc - deficiency ; Zinc - therapeutic use</subject><ispartof>Clinical infectious diseases, 2010-06, Vol.50 (12), p.1653-1660</ispartof><rights>2010 Infectious Diseases Society of America</rights><rights>2010 by the Infectious Diseases Society of America 2010</rights><rights>2015 INIST-CNRS</rights><rights>Copyright University of Chicago, acting through its Press Jun 15, 2010</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c485t-9abc55ef399519a825d73169c0d4069b50811762a48d1a230dce85b3337ec36e3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.jstor.org/stable/pdf/25679931$$EPDF$$P50$$Gjstor$$H</linktopdf><linktohtml>$$Uhttps://www.jstor.org/stable/25679931$$EHTML$$P50$$Gjstor$$H</linktohtml><link.rule.ids>314,776,780,799,27901,27902,57992,58225</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22853977$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20455705$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Baum, Marianna K.</creatorcontrib><creatorcontrib>Lai, Shenghan</creatorcontrib><creatorcontrib>Sales, Sabrina</creatorcontrib><creatorcontrib>Page, J. Bryan</creatorcontrib><creatorcontrib>Campa, Adriana</creatorcontrib><title>Randomized, Controlled Clinical Trial of Zinc Supplementation to Prevent Immunological Failure in HIV-Infected Adults</title><title>Clinical infectious diseases</title><addtitle>Clinical Infectious Diseases</addtitle><addtitle>Clinical Infectious Diseases</addtitle><description>Background. Adequate zinc is critical for immune function; however, zinc deficiency occurs in 150% of human immunodeficiency virus (HIV)-infected adults. We examined the safety and efficacy of long-term zinc supplementation in relation to HIV disease progression. Methods. A prospective, randomized, controlled clinical trial was conducted involving 231 HIV-infected adults with low plasma zinc levels (<0.75 mg/L), who were randomly assigned to receive zinc (12 mg of elemental zinc for women and 15 mg for men) or placebo for 18 months. The primary end point was immunological failure. HIV viral load and CD4+ cell count were determined every 6 months. Questionnaires, pill counts, and plasma zinc and C-reactive protein levels were used to monitor adherence to study supplements and antiretroviral therapy. Intent-to-treat analysis used multiple-event analysis, treating CD4+ cell count <200 cells/mm3 as a recurrent immunological failure event. Cox proportional hazard models and the general-linear model were used to analyze morbidity and mortality data. Results. Zinc supplementation for 18 months reduced 4-fold the likelihood of immunological failure, controlling for age, sex, food insecurity, baseline CD4+ cell count, viral load, and antiretroviral therapy (relative rate, 0.24; 95% confidence interval, 0.10-0.56; P < .002). Viral load indicated poor control with antiretroviral therapy but was not affected by zinc supplementation. Zinc supplementation also reduced the rate of diarrhea by more than half (odds ratio, 0.4; 95% confidence interval, 0.183-0.981; Pp.019), compared with placebo. There was no significant difference in mortality between the 2 groups. Conclusions. This study demonstrated that long-term (18-month) zinc supplementation at nutritional levels delayed immunological failure and decreased diarrhea over time. This evidence supports the use of zinc supplementation as an adjunct therapy for HIV-infected adult cohorts with poor viral control. Trial registration. ClinicalTrials.gov identifier: NCT00149552.</description><subject>Adult</subject><subject>Adults</subject><subject>AIDS</subject><subject>Arts</subject><subject>Biological and medical sciences</subject><subject>CD4 Lymphocyte Count</subject><subject>Clinical medicine</subject><subject>Diarrhea</subject><subject>Dietary Supplements</subject><subject>Disease Progression</subject><subject>Female</subject><subject>HIV</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - immunology</subject><subject>HIV Infections - mortality</subject><subject>HIV/AIDS</subject><subject>Human immunodeficiency virus</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Immune System Diseases - prevention & control</subject><subject>Immunodeficiencies</subject><subject>Immunodeficiencies. Immunoglobulinopathies</subject><subject>Immunology</subject><subject>Immunopathology</subject><subject>Infectious diseases</subject><subject>Male</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Morbidity</subject><subject>Mortality</subject><subject>Placebos</subject><subject>Treatment Outcome</subject><subject>Viral diseases</subject><subject>Viral diseases of the lymphoid tissue and the blood. Aids</subject><subject>Viral Load</subject><subject>Zinc</subject><subject>Zinc - deficiency</subject><subject>Zinc - therapeutic use</subject><issn>1058-4838</issn><issn>1537-6591</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqF0VuL1DAUAOAiiruO-g-UKqgvVpOmJ5fHZdhxRhYcdJVlX0omTSVjmtQkXdRfb7TjLgjiSy6cLyfJOUXxEKNXGHH6mkLNaXOrOMZAWEVB4Nt5jYBXDSf8qLgX4x4hjDmCu8VRjRoAhuC4mN5L1_nB_NDdy3LpXQreWt2VS2ucUdKW58Hk0fflpXGq_DCNo9WDdkkm412ZfLkN-irvy80wTM5b__n3sZU0dgq6NK5cbz5VG9drlXLek26yKd4v7vTSRv3gMC-Kj6vT8-W6Onv3ZrM8OatUwyFVQu4UgO6JEICF5DV0jGAqFOoaRMUOEMeY0Vo2vMOyJqhTmsOOEMK0IlSTRfFizjsG_3XSMbWDiUpbK532U2wZNNDUjNf_l4RAwyhHWT79S-79FFz-RksaigkmTGT0fEYq-BiD7tsxmEGG7y1G7a-GtXPDMnx8yDbtBt1dsz8dyuDZAciYC9sH6ZSJN67mQARj2T2ZnZ_Gf1_2aDb7mHy4yQGUCZEfviiqOW5i0t-u4zJ8aSkjDNr1xWW7Xa-2y7cXOJfkJ4C8vfc</recordid><startdate>20100615</startdate><enddate>20100615</enddate><creator>Baum, Marianna K.</creator><creator>Lai, Shenghan</creator><creator>Sales, Sabrina</creator><creator>Page, J. Bryan</creator><creator>Campa, Adriana</creator><general>The University of Chicago Press</general><general>University of Chicago Press</general><general>Oxford University Press</general><scope>BSCLL</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7T2</scope><scope>7T7</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>P64</scope><scope>7X8</scope><scope>7T5</scope><scope>7U2</scope></search><sort><creationdate>20100615</creationdate><title>Randomized, Controlled Clinical Trial of Zinc Supplementation to Prevent Immunological Failure in HIV-Infected Adults</title><author>Baum, Marianna K. ; Lai, Shenghan ; Sales, Sabrina ; Page, J. 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Bryan</creatorcontrib><creatorcontrib>Campa, Adriana</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><collection>Immunology Abstracts</collection><collection>Safety Science and Risk</collection><jtitle>Clinical infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Baum, Marianna K.</au><au>Lai, Shenghan</au><au>Sales, Sabrina</au><au>Page, J. Bryan</au><au>Campa, Adriana</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized, Controlled Clinical Trial of Zinc Supplementation to Prevent Immunological Failure in HIV-Infected Adults</atitle><jtitle>Clinical infectious diseases</jtitle><stitle>Clinical Infectious Diseases</stitle><addtitle>Clinical Infectious Diseases</addtitle><date>2010-06-15</date><risdate>2010</risdate><volume>50</volume><issue>12</issue><spage>1653</spage><epage>1660</epage><pages>1653-1660</pages><issn>1058-4838</issn><eissn>1537-6591</eissn><coden>CIDIEL</coden><abstract>Background. Adequate zinc is critical for immune function; however, zinc deficiency occurs in 150% of human immunodeficiency virus (HIV)-infected adults. We examined the safety and efficacy of long-term zinc supplementation in relation to HIV disease progression. Methods. A prospective, randomized, controlled clinical trial was conducted involving 231 HIV-infected adults with low plasma zinc levels (<0.75 mg/L), who were randomly assigned to receive zinc (12 mg of elemental zinc for women and 15 mg for men) or placebo for 18 months. The primary end point was immunological failure. HIV viral load and CD4+ cell count were determined every 6 months. Questionnaires, pill counts, and plasma zinc and C-reactive protein levels were used to monitor adherence to study supplements and antiretroviral therapy. Intent-to-treat analysis used multiple-event analysis, treating CD4+ cell count <200 cells/mm3 as a recurrent immunological failure event. Cox proportional hazard models and the general-linear model were used to analyze morbidity and mortality data. Results. Zinc supplementation for 18 months reduced 4-fold the likelihood of immunological failure, controlling for age, sex, food insecurity, baseline CD4+ cell count, viral load, and antiretroviral therapy (relative rate, 0.24; 95% confidence interval, 0.10-0.56; P < .002). Viral load indicated poor control with antiretroviral therapy but was not affected by zinc supplementation. Zinc supplementation also reduced the rate of diarrhea by more than half (odds ratio, 0.4; 95% confidence interval, 0.183-0.981; Pp.019), compared with placebo. There was no significant difference in mortality between the 2 groups. Conclusions. This study demonstrated that long-term (18-month) zinc supplementation at nutritional levels delayed immunological failure and decreased diarrhea over time. This evidence supports the use of zinc supplementation as an adjunct therapy for HIV-infected adult cohorts with poor viral control. Trial registration. ClinicalTrials.gov identifier: NCT00149552.</abstract><cop>Oxford</cop><pub>The University of Chicago Press</pub><pmid>20455705</pmid><doi>10.1086/652864</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Adult Adults AIDS Arts Biological and medical sciences CD4 Lymphocyte Count Clinical medicine Diarrhea Dietary Supplements Disease Progression Female HIV HIV Infections - drug therapy HIV Infections - immunology HIV Infections - mortality HIV/AIDS Human immunodeficiency virus Human viral diseases Humans Immune System Diseases - prevention & control Immunodeficiencies Immunodeficiencies. Immunoglobulinopathies Immunology Immunopathology Infectious diseases Male Medical research Medical sciences Middle Aged Morbidity Mortality Placebos Treatment Outcome Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids Viral Load Zinc Zinc - deficiency Zinc - therapeutic use |
title | Randomized, Controlled Clinical Trial of Zinc Supplementation to Prevent Immunological Failure in HIV-Infected Adults |
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