Vitamin D₃ Supplementation in Batswana Children and Adults with HIV: A Pilot Double Blind Randomized Controlled Trial
Objectives Since vitamin D insufficiency is common worldwide in people with HIV, we explored safety and efficacy of high dose cholecalciferol (D₃) in Botswana, and evaluated potential modifiers of serum 25 hydroxy vitamin D change (Δ25D). Design Prospective randomized double-blind 12-week pilot tria...
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| creator | Steenhoff, Andrew P. Schall, Joan I. Samuel, Julia Seme, Boitshepo Marape, Marape Ratshaa, Bakgaki Goercke, Irene Tolle, Michael Nnyepi, Maria S. Mazhani, Loeto Zemel, Babette S. Rutstein, Richard M. Stallings, Virginia A. |
| description | Objectives Since vitamin D insufficiency is common worldwide in people with HIV, we explored safety and efficacy of high dose cholecalciferol (D₃) in Botswana, and evaluated potential modifiers of serum 25 hydroxy vitamin D change (Δ25D). Design Prospective randomized double-blind 12-week pilot trial of subjects ages 5.0–50.9 years. Methods Sixty subjects randomized within five age groups to either 4000 or 7000IU per day of D₃ and evaluated for vitamin D, parathyroid hormone, HIV, safety and growth status. Efficacy was defined as serum 25 hydroxy vitamin D (25D) ≥32ng/mL, and safety as no simultaneous elevation of serum calcium and 25D. Also assessed were HIV plasma viral RNA viral load (VL), CD4%, anti-retroviral therapy (ART) regime, and height-adjusted (HAZ), weight-adjusted (WAZ) and Body Mass Index (BMIZ) Z scores. Results Subjects were 50% male, age (mean±SD) 19.5±11.8 years, CD4% 31.8±10.4, with baseline VL log₁₀ range of 1.4) in 22%. From baseline to 12 weeks, 25D increased from 36±9ng/ml to 56±18ng/ml (p |
| doi_str_mv | 10.1371/journal.pone.0117123 |
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| fullrecord | <record><control><sourceid>proquest_plos_</sourceid><recordid>TN_cdi_plos_journals_1658064429</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3604058611</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3193-a1d5b2aec40ce40a5d20b129d09be0ddc4482d491d6a93af9bcb8cf875199da03</originalsourceid><addsrcrecordid>eNp1kd9OFDEUxhuiAUTfgMQmXu_afzM79cJkWVRISCSI3DZnpl22pNMObYcNXOKb-iSWMBq98OqcnP76fT39EDqkZE75gr6_CWP04OZD8GZOKF1QxnfQPpWczWpG-Iu_-j30KqUbQire1PUu2mPVgtSLiu6j7ZXN0FuPj38-_sDfxmFwpjc-Q7bB4zI_gpy24AGvNtbpaDwGr_FSjy4nvLV5g09Orz7gJT63LmR8HMbWGXzkbKEuChp6-2A0XgWfY3CutJfRgnuNXq7BJfNmqgfo--dPl6uT2dnXL6er5dms4-X1M6C6ahmYTpDOCAKVZqSlTGoiW0O07oRomBaS6hokh7Vsu7bp1k3ZTUoNhB-gt8-6gwtJTX-WFK2rhtRCMFmIjxMxtr3RXVk-glNDtD3EexXAqn9PvN2o63CnBOcN41UReDcJxHA7mpT_YyOeqS6GlKJZ_3GgRD0F-vuWegpUTYHyX1nxl3Y</addsrcrecordid><sourcetype>Open Website</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1658064429</pqid></control><display><type>article</type><title>Vitamin D₃ Supplementation in Batswana Children and Adults with HIV: A Pilot Double Blind Randomized Controlled Trial</title><source>DOAJ Directory of Open Access Journals</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Public Library of Science (PLoS) Journals Open Access</source><source>PubMed Central</source><source>Free Full-Text Journals in Chemistry</source><creator>Steenhoff, Andrew P. ; Schall, Joan I. ; Samuel, Julia ; Seme, Boitshepo ; Marape, Marape ; Ratshaa, Bakgaki ; Goercke, Irene ; Tolle, Michael ; Nnyepi, Maria S. ; Mazhani, Loeto ; Zemel, Babette S. ; Rutstein, Richard M. ; Stallings, Virginia A.</creator><contributor>Diemert, David Joseph</contributor><creatorcontrib>Steenhoff, Andrew P. ; Schall, Joan I. ; Samuel, Julia ; Seme, Boitshepo ; Marape, Marape ; Ratshaa, Bakgaki ; Goercke, Irene ; Tolle, Michael ; Nnyepi, Maria S. ; Mazhani, Loeto ; Zemel, Babette S. ; Rutstein, Richard M. ; Stallings, Virginia A. ; Diemert, David Joseph</creatorcontrib><description>Objectives Since vitamin D insufficiency is common worldwide in people with HIV, we explored safety and efficacy of high dose cholecalciferol (D₃) in Botswana, and evaluated potential modifiers of serum 25 hydroxy vitamin D change (Δ25D). Design Prospective randomized double-blind 12-week pilot trial of subjects ages 5.0–50.9 years. Methods Sixty subjects randomized within five age groups to either 4000 or 7000IU per day of D₃ and evaluated for vitamin D, parathyroid hormone, HIV, safety and growth status. Efficacy was defined as serum 25 hydroxy vitamin D (25D) ≥32ng/mL, and safety as no simultaneous elevation of serum calcium and 25D. Also assessed were HIV plasma viral RNA viral load (VL), CD4%, anti-retroviral therapy (ART) regime, and height-adjusted (HAZ), weight-adjusted (WAZ) and Body Mass Index (BMIZ) Z scores. Results Subjects were 50% male, age (mean±SD) 19.5±11.8 years, CD4% 31.8±10.4, with baseline VL log₁₀ range of <1.4 to 3.8 and VL detectable (>1.4) in 22%. From baseline to 12 weeks, 25D increased from 36±9ng/ml to 56±18ng/ml (p<0.0001) and 68% and 90% had 25D ≥32ng/ml, respectively (p = 0.02). Δ25D was similar by dose. No subjects had simultaneously increased serum calcium and 25D. WAZ and BMIZ improved by 12 weeks (p<0.04). HAZ and CD4% increased and VL decreased in the 7000IU/d group (p<0.04). Younger (5–13y) and older (30–50y) subjects had greater Δ25D than those 14–29y (26±17 and 28±12 vs. 11±11ng/ml, respectively, p≤0.001). Δ25D was higher with efavirenz or nevirapine compared to protease inhibitor based treatment (22±12, 27±17, vs. 13±10, respectively, p≤0.03). Conclusions In a pilot study in Botswana, 12-week high dose D₃ supplementation was safe and improved vitamin D, growth and HIV status; age and ART regimen were significant effect modifiers. Trial Registration ClinicalTrials.gov NCT02189902</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0117123</identifier><identifier>PMID: 25706751</identifier><language>eng</language><publisher>San Francisco: Public Library of Science</publisher><subject>Adults ; Age ; Antiretroviral drugs ; Body mass ; Body mass index ; Body size ; Calcium ; Calcium (blood) ; CD4 antigen ; Children ; Design modifications ; Double-blind studies ; Efavirenz ; Heat affected zone ; HIV ; Human immunodeficiency virus ; Laboratories ; Medical diagnosis ; Nevirapine ; Nutrition ; Parathyroid ; Parathyroid hormone ; Proteinase inhibitors ; Randomization ; Ribonucleic acid ; RNA ; Safety ; Supplements ; Teenagers ; Vitamin D ; Womens health</subject><ispartof>PloS one, 2015-02, Vol.10 (2), p.e0117123</ispartof><rights>2015 Steenhoff et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2015 Steenhoff et al 2015 Steenhoff et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3193-a1d5b2aec40ce40a5d20b129d09be0ddc4482d491d6a93af9bcb8cf875199da03</citedby><cites>FETCH-LOGICAL-c3193-a1d5b2aec40ce40a5d20b129d09be0ddc4482d491d6a93af9bcb8cf875199da03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4338235/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4338235/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,315,728,781,785,865,886,2929,23871,27929,27930,53796,53798</link.rule.ids></links><search><contributor>Diemert, David Joseph</contributor><creatorcontrib>Steenhoff, Andrew P.</creatorcontrib><creatorcontrib>Schall, Joan I.</creatorcontrib><creatorcontrib>Samuel, Julia</creatorcontrib><creatorcontrib>Seme, Boitshepo</creatorcontrib><creatorcontrib>Marape, Marape</creatorcontrib><creatorcontrib>Ratshaa, Bakgaki</creatorcontrib><creatorcontrib>Goercke, Irene</creatorcontrib><creatorcontrib>Tolle, Michael</creatorcontrib><creatorcontrib>Nnyepi, Maria S.</creatorcontrib><creatorcontrib>Mazhani, Loeto</creatorcontrib><creatorcontrib>Zemel, Babette S.</creatorcontrib><creatorcontrib>Rutstein, Richard M.</creatorcontrib><creatorcontrib>Stallings, Virginia A.</creatorcontrib><title>Vitamin D₃ Supplementation in Batswana Children and Adults with HIV: A Pilot Double Blind Randomized Controlled Trial</title><title>PloS one</title><description>Objectives Since vitamin D insufficiency is common worldwide in people with HIV, we explored safety and efficacy of high dose cholecalciferol (D₃) in Botswana, and evaluated potential modifiers of serum 25 hydroxy vitamin D change (Δ25D). Design Prospective randomized double-blind 12-week pilot trial of subjects ages 5.0–50.9 years. Methods Sixty subjects randomized within five age groups to either 4000 or 7000IU per day of D₃ and evaluated for vitamin D, parathyroid hormone, HIV, safety and growth status. Efficacy was defined as serum 25 hydroxy vitamin D (25D) ≥32ng/mL, and safety as no simultaneous elevation of serum calcium and 25D. Also assessed were HIV plasma viral RNA viral load (VL), CD4%, anti-retroviral therapy (ART) regime, and height-adjusted (HAZ), weight-adjusted (WAZ) and Body Mass Index (BMIZ) Z scores. Results Subjects were 50% male, age (mean±SD) 19.5±11.8 years, CD4% 31.8±10.4, with baseline VL log₁₀ range of <1.4 to 3.8 and VL detectable (>1.4) in 22%. From baseline to 12 weeks, 25D increased from 36±9ng/ml to 56±18ng/ml (p<0.0001) and 68% and 90% had 25D ≥32ng/ml, respectively (p = 0.02). Δ25D was similar by dose. No subjects had simultaneously increased serum calcium and 25D. WAZ and BMIZ improved by 12 weeks (p<0.04). HAZ and CD4% increased and VL decreased in the 7000IU/d group (p<0.04). Younger (5–13y) and older (30–50y) subjects had greater Δ25D than those 14–29y (26±17 and 28±12 vs. 11±11ng/ml, respectively, p≤0.001). Δ25D was higher with efavirenz or nevirapine compared to protease inhibitor based treatment (22±12, 27±17, vs. 13±10, respectively, p≤0.03). Conclusions In a pilot study in Botswana, 12-week high dose D₃ supplementation was safe and improved vitamin D, growth and HIV status; age and ART regimen were significant effect modifiers. 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D₃ Supplementation in Batswana Children and Adults with HIV: A Pilot Double Blind Randomized Controlled Trial</title><author>Steenhoff, Andrew P. ; Schall, Joan I. ; Samuel, Julia ; Seme, Boitshepo ; Marape, Marape ; Ratshaa, Bakgaki ; Goercke, Irene ; Tolle, Michael ; Nnyepi, Maria S. ; Mazhani, Loeto ; Zemel, Babette S. ; Rutstein, Richard M. ; Stallings, Virginia A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3193-a1d5b2aec40ce40a5d20b129d09be0ddc4482d491d6a93af9bcb8cf875199da03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adults</topic><topic>Age</topic><topic>Antiretroviral drugs</topic><topic>Body mass</topic><topic>Body mass index</topic><topic>Body size</topic><topic>Calcium</topic><topic>Calcium (blood)</topic><topic>CD4 antigen</topic><topic>Children</topic><topic>Design modifications</topic><topic>Double-blind studies</topic><topic>Efavirenz</topic><topic>Heat affected zone</topic><topic>HIV</topic><topic>Human immunodeficiency virus</topic><topic>Laboratories</topic><topic>Medical diagnosis</topic><topic>Nevirapine</topic><topic>Nutrition</topic><topic>Parathyroid</topic><topic>Parathyroid hormone</topic><topic>Proteinase inhibitors</topic><topic>Randomization</topic><topic>Ribonucleic acid</topic><topic>RNA</topic><topic>Safety</topic><topic>Supplements</topic><topic>Teenagers</topic><topic>Vitamin D</topic><topic>Womens health</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Steenhoff, Andrew P.</creatorcontrib><creatorcontrib>Schall, Joan I.</creatorcontrib><creatorcontrib>Samuel, Julia</creatorcontrib><creatorcontrib>Seme, Boitshepo</creatorcontrib><creatorcontrib>Marape, Marape</creatorcontrib><creatorcontrib>Ratshaa, Bakgaki</creatorcontrib><creatorcontrib>Goercke, Irene</creatorcontrib><creatorcontrib>Tolle, 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Joseph</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Vitamin D₃ Supplementation in Batswana Children and Adults with HIV: A Pilot Double Blind Randomized Controlled Trial</atitle><jtitle>PloS one</jtitle><date>2015-02-23</date><risdate>2015</risdate><volume>10</volume><issue>2</issue><spage>e0117123</spage><pages>e0117123-</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Objectives Since vitamin D insufficiency is common worldwide in people with HIV, we explored safety and efficacy of high dose cholecalciferol (D₃) in Botswana, and evaluated potential modifiers of serum 25 hydroxy vitamin D change (Δ25D). Design Prospective randomized double-blind 12-week pilot trial of subjects ages 5.0–50.9 years. Methods Sixty subjects randomized within five age groups to either 4000 or 7000IU per day of D₃ and evaluated for vitamin D, parathyroid hormone, HIV, safety and growth status. Efficacy was defined as serum 25 hydroxy vitamin D (25D) ≥32ng/mL, and safety as no simultaneous elevation of serum calcium and 25D. Also assessed were HIV plasma viral RNA viral load (VL), CD4%, anti-retroviral therapy (ART) regime, and height-adjusted (HAZ), weight-adjusted (WAZ) and Body Mass Index (BMIZ) Z scores. Results Subjects were 50% male, age (mean±SD) 19.5±11.8 years, CD4% 31.8±10.4, with baseline VL log₁₀ range of <1.4 to 3.8 and VL detectable (>1.4) in 22%. From baseline to 12 weeks, 25D increased from 36±9ng/ml to 56±18ng/ml (p<0.0001) and 68% and 90% had 25D ≥32ng/ml, respectively (p = 0.02). Δ25D was similar by dose. No subjects had simultaneously increased serum calcium and 25D. WAZ and BMIZ improved by 12 weeks (p<0.04). HAZ and CD4% increased and VL decreased in the 7000IU/d group (p<0.04). Younger (5–13y) and older (30–50y) subjects had greater Δ25D than those 14–29y (26±17 and 28±12 vs. 11±11ng/ml, respectively, p≤0.001). Δ25D was higher with efavirenz or nevirapine compared to protease inhibitor based treatment (22±12, 27±17, vs. 13±10, respectively, p≤0.03). Conclusions In a pilot study in Botswana, 12-week high dose D₃ supplementation was safe and improved vitamin D, growth and HIV status; age and ART regimen were significant effect modifiers. Trial Registration ClinicalTrials.gov NCT02189902</abstract><cop>San Francisco</cop><pub>Public Library of Science</pub><pmid>25706751</pmid><doi>10.1371/journal.pone.0117123</doi><oa>free_for_read</oa></addata></record> |
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| source | DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Public Library of Science (PLoS) Journals Open Access; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Adults Age Antiretroviral drugs Body mass Body mass index Body size Calcium Calcium (blood) CD4 antigen Children Design modifications Double-blind studies Efavirenz Heat affected zone HIV Human immunodeficiency virus Laboratories Medical diagnosis Nevirapine Nutrition Parathyroid Parathyroid hormone Proteinase inhibitors Randomization Ribonucleic acid RNA Safety Supplements Teenagers Vitamin D Womens health |
| title | Vitamin D₃ Supplementation in Batswana Children and Adults with HIV: A Pilot Double Blind Randomized Controlled Trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-13T23%3A15%3A52IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Vitamin%20D%E2%82%83%20Supplementation%20in%20Batswana%20Children%20and%20Adults%20with%20HIV:%20A%20Pilot%20Double%20Blind%20Randomized%20Controlled%20Trial&rft.jtitle=PloS%20one&rft.au=Steenhoff,%20Andrew%20P.&rft.date=2015-02-23&rft.volume=10&rft.issue=2&rft.spage=e0117123&rft.pages=e0117123-&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0117123&rft_dat=%3Cproquest_plos_%3E3604058611%3C/proquest_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1658064429&rft_id=info:pmid/25706751&rfr_iscdi=true |