Recruitment and Results of a Pilot Trial of Vitamin D Supplementation in the General Population of Australia
Context: The benefits of high serum levels of 25-hydroxyvitamin D [25(OH)D] are unclear. Trials are needed to establish an appropriate evidence base. Objective: We plan to conduct a large-scale trial of vitamin D supplementation for the reduction of cancer incidence and overall mortality and report...
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| Veröffentlicht in: | The journal of clinical endocrinology and metabolism 2012-12, Vol.97 (12), p.4473-4480 |
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| container_title | The journal of clinical endocrinology and metabolism |
| container_volume | 97 |
| creator | Tran, Bich Armstrong, Bruce K Carlin, John B Ebeling, Peter R English, Dallas R Kimlin, Michael G Rahman, Bayzidur van der Pols, Jolieke C Venn, Alison Gebski, Val Whiteman, David C Webb, Penelope M Neale, Rachel E |
| description | Context:
The benefits of high serum levels of 25-hydroxyvitamin D [25(OH)D] are unclear. Trials are needed to establish an appropriate evidence base.
Objective:
We plan to conduct a large-scale trial of vitamin D supplementation for the reduction of cancer incidence and overall mortality and report here the methods and results of a pilot trial established to inform its design.
Design:
Pilot D-Health was a randomized trial carried out in a general community setting with 12 months intervention and follow-up.
Participants:
Participants were 60- to 84-yr-old residents of one of the four eastern Australian states who did not have any vitamin D-related disorders and who were not taking more than 400 IU supplementary vitamin D per day. A total of 644 participants were randomized, and 615 completed the study (two persons withdrew because of nonserious adverse events).
Interventions:
The interventions were monthly doses of placebo or 30,000 or 60,000 IU vitamin D3.
Main Outcomes:
The main outcomes were the recruitment rate and changes in serum 25(OH)D.
Results:
Ten percent of those approached were recruited. At baseline, the mean 25(OH)D was 42 nmol/liter in all three study arms. The mean change in 25(OH)D in the placebo group was 0.12 nmol/liter, compared with changes of 22 and 36 nmol/liter in the 30,000- and 60,000-IU groups, respectively.
Conclusions:
The D-Health pilot has shown that a large trial is feasible in Australia and that a dose of 2000 IU/d will be needed to ensure that a large proportion of the population reaches the target serum 25(OH)D level. |
| doi_str_mv | 10.1210/jc.2012-2682 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1237506310</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1237506310</sourcerecordid><originalsourceid>FETCH-LOGICAL-c403t-d3999e28efa9df143c0606be9280308483cba31572f61e9be631046d15010fb83</originalsourceid><addsrcrecordid>eNptkL9v1TAUhS0Eoo_Cxoy8IDGQ1tdOnHisWihIlVq1BbFZjnMj_OQ4wT8G_vsmeg9YmCwdf-dc6SPkLbAz4MDO9_aMM-AVlx1_Rnag6qZqQbXPyY4xDpVq-Y8T8iqlPWNQ1414SU64YFICqB3x92hjcXnCkKkJA73HVHxOdB6poXfOz5k-Rmf8Fnx32Uwu0Cv6UJbF41Yy2c2BrmH-ifQaA8aVvZuX4g8_a-2ipLymzrwmL0bjE745vqfk2-dPj5dfqpvb66-XFzeVrZnI1SCUUsg7HI0aRqiFZZLJHhXvmGBd3QnbGwFNy0cJqHqUAlgtB2gYsLHvxCn5cNhd4vyrYMp6csmi9ybgXJIGLtqGba0V_XhAbZxTijjqJbrJxN8amN786r3Vm1-9-V3xd8fl0k84_IX_CF2B90fAJGv8GE2wLv3jZCvrDrYhceAwDLONLuASMSW9n0sMq5v_n38C_k-TJQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1237506310</pqid></control><display><type>article</type><title>Recruitment and Results of a Pilot Trial of Vitamin D Supplementation in the General Population of Australia</title><source>MEDLINE</source><source>Journals@Ovid Complete</source><source>Oxford University Press Journals All Titles (1996-Current)</source><source>EZB-FREE-00999 freely available EZB journals</source><source>Alma/SFX Local Collection</source><creator>Tran, Bich ; Armstrong, Bruce K ; Carlin, John B ; Ebeling, Peter R ; English, Dallas R ; Kimlin, Michael G ; Rahman, Bayzidur ; van der Pols, Jolieke C ; Venn, Alison ; Gebski, Val ; Whiteman, David C ; Webb, Penelope M ; Neale, Rachel E</creator><creatorcontrib>Tran, Bich ; Armstrong, Bruce K ; Carlin, John B ; Ebeling, Peter R ; English, Dallas R ; Kimlin, Michael G ; Rahman, Bayzidur ; van der Pols, Jolieke C ; Venn, Alison ; Gebski, Val ; Whiteman, David C ; Webb, Penelope M ; Neale, Rachel E</creatorcontrib><description>Context:
The benefits of high serum levels of 25-hydroxyvitamin D [25(OH)D] are unclear. Trials are needed to establish an appropriate evidence base.
Objective:
We plan to conduct a large-scale trial of vitamin D supplementation for the reduction of cancer incidence and overall mortality and report here the methods and results of a pilot trial established to inform its design.
Design:
Pilot D-Health was a randomized trial carried out in a general community setting with 12 months intervention and follow-up.
Participants:
Participants were 60- to 84-yr-old residents of one of the four eastern Australian states who did not have any vitamin D-related disorders and who were not taking more than 400 IU supplementary vitamin D per day. A total of 644 participants were randomized, and 615 completed the study (two persons withdrew because of nonserious adverse events).
Interventions:
The interventions were monthly doses of placebo or 30,000 or 60,000 IU vitamin D3.
Main Outcomes:
The main outcomes were the recruitment rate and changes in serum 25(OH)D.
Results:
Ten percent of those approached were recruited. At baseline, the mean 25(OH)D was 42 nmol/liter in all three study arms. The mean change in 25(OH)D in the placebo group was 0.12 nmol/liter, compared with changes of 22 and 36 nmol/liter in the 30,000- and 60,000-IU groups, respectively.
Conclusions:
The D-Health pilot has shown that a large trial is feasible in Australia and that a dose of 2000 IU/d will be needed to ensure that a large proportion of the population reaches the target serum 25(OH)D level.</description><identifier>ISSN: 0021-972X</identifier><identifier>EISSN: 1945-7197</identifier><identifier>DOI: 10.1210/jc.2012-2682</identifier><identifier>PMID: 23066119</identifier><identifier>CODEN: JCEMAZ</identifier><language>eng</language><publisher>Bethesda, MD: Endocrine Society</publisher><subject>Aged ; Aged, 80 and over ; Australia - epidemiology ; Biological and medical sciences ; Chronic Disease - epidemiology ; Chronic Disease - mortality ; Dietary Supplements ; Double-Blind Method ; Endocrinopathies ; Feeding. Feeding behavior ; Female ; Fundamental and applied biological sciences. Psychology ; Humans ; Male ; Medical sciences ; Middle Aged ; Neoplasms - epidemiology ; Neoplasms - mortality ; Neoplasms - prevention & control ; Patient Selection ; Pilot Projects ; Placebos ; Population ; Survival Analysis ; Vertebrates: anatomy and physiology, studies on body, several organs or systems ; Vertebrates: endocrinology ; Vitamin D - administration & dosage</subject><ispartof>The journal of clinical endocrinology and metabolism, 2012-12, Vol.97 (12), p.4473-4480</ispartof><rights>Copyright © 2012 by The Endocrine Society</rights><rights>2014 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c403t-d3999e28efa9df143c0606be9280308483cba31572f61e9be631046d15010fb83</citedby><cites>FETCH-LOGICAL-c403t-d3999e28efa9df143c0606be9280308483cba31572f61e9be631046d15010fb83</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26764812$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23066119$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tran, Bich</creatorcontrib><creatorcontrib>Armstrong, Bruce K</creatorcontrib><creatorcontrib>Carlin, John B</creatorcontrib><creatorcontrib>Ebeling, Peter R</creatorcontrib><creatorcontrib>English, Dallas R</creatorcontrib><creatorcontrib>Kimlin, Michael G</creatorcontrib><creatorcontrib>Rahman, Bayzidur</creatorcontrib><creatorcontrib>van der Pols, Jolieke C</creatorcontrib><creatorcontrib>Venn, Alison</creatorcontrib><creatorcontrib>Gebski, Val</creatorcontrib><creatorcontrib>Whiteman, David C</creatorcontrib><creatorcontrib>Webb, Penelope M</creatorcontrib><creatorcontrib>Neale, Rachel E</creatorcontrib><title>Recruitment and Results of a Pilot Trial of Vitamin D Supplementation in the General Population of Australia</title><title>The journal of clinical endocrinology and metabolism</title><addtitle>J Clin Endocrinol Metab</addtitle><description>Context:
The benefits of high serum levels of 25-hydroxyvitamin D [25(OH)D] are unclear. Trials are needed to establish an appropriate evidence base.
Objective:
We plan to conduct a large-scale trial of vitamin D supplementation for the reduction of cancer incidence and overall mortality and report here the methods and results of a pilot trial established to inform its design.
Design:
Pilot D-Health was a randomized trial carried out in a general community setting with 12 months intervention and follow-up.
Participants:
Participants were 60- to 84-yr-old residents of one of the four eastern Australian states who did not have any vitamin D-related disorders and who were not taking more than 400 IU supplementary vitamin D per day. A total of 644 participants were randomized, and 615 completed the study (two persons withdrew because of nonserious adverse events).
Interventions:
The interventions were monthly doses of placebo or 30,000 or 60,000 IU vitamin D3.
Main Outcomes:
The main outcomes were the recruitment rate and changes in serum 25(OH)D.
Results:
Ten percent of those approached were recruited. At baseline, the mean 25(OH)D was 42 nmol/liter in all three study arms. The mean change in 25(OH)D in the placebo group was 0.12 nmol/liter, compared with changes of 22 and 36 nmol/liter in the 30,000- and 60,000-IU groups, respectively.
Conclusions:
The D-Health pilot has shown that a large trial is feasible in Australia and that a dose of 2000 IU/d will be needed to ensure that a large proportion of the population reaches the target serum 25(OH)D level.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Australia - epidemiology</subject><subject>Biological and medical sciences</subject><subject>Chronic Disease - epidemiology</subject><subject>Chronic Disease - mortality</subject><subject>Dietary Supplements</subject><subject>Double-Blind Method</subject><subject>Endocrinopathies</subject><subject>Feeding. Feeding behavior</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Neoplasms - epidemiology</subject><subject>Neoplasms - mortality</subject><subject>Neoplasms - prevention & control</subject><subject>Patient Selection</subject><subject>Pilot Projects</subject><subject>Placebos</subject><subject>Population</subject><subject>Survival Analysis</subject><subject>Vertebrates: anatomy and physiology, studies on body, several organs or systems</subject><subject>Vertebrates: endocrinology</subject><subject>Vitamin D - administration & dosage</subject><issn>0021-972X</issn><issn>1945-7197</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNptkL9v1TAUhS0Eoo_Cxoy8IDGQ1tdOnHisWihIlVq1BbFZjnMj_OQ4wT8G_vsmeg9YmCwdf-dc6SPkLbAz4MDO9_aMM-AVlx1_Rnag6qZqQbXPyY4xDpVq-Y8T8iqlPWNQ1414SU64YFICqB3x92hjcXnCkKkJA73HVHxOdB6poXfOz5k-Rmf8Fnx32Uwu0Cv6UJbF41Yy2c2BrmH-ifQaA8aVvZuX4g8_a-2ipLymzrwmL0bjE745vqfk2-dPj5dfqpvb66-XFzeVrZnI1SCUUsg7HI0aRqiFZZLJHhXvmGBd3QnbGwFNy0cJqHqUAlgtB2gYsLHvxCn5cNhd4vyrYMp6csmi9ybgXJIGLtqGba0V_XhAbZxTijjqJbrJxN8amN786r3Vm1-9-V3xd8fl0k84_IX_CF2B90fAJGv8GE2wLv3jZCvrDrYhceAwDLONLuASMSW9n0sMq5v_n38C_k-TJQ</recordid><startdate>20121201</startdate><enddate>20121201</enddate><creator>Tran, Bich</creator><creator>Armstrong, Bruce K</creator><creator>Carlin, John B</creator><creator>Ebeling, Peter R</creator><creator>English, Dallas R</creator><creator>Kimlin, Michael G</creator><creator>Rahman, Bayzidur</creator><creator>van der Pols, Jolieke C</creator><creator>Venn, Alison</creator><creator>Gebski, Val</creator><creator>Whiteman, David C</creator><creator>Webb, Penelope M</creator><creator>Neale, Rachel E</creator><general>Endocrine Society</general><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>7X8</scope></search><sort><creationdate>20121201</creationdate><title>Recruitment and Results of a Pilot Trial of Vitamin D Supplementation in the General Population of Australia</title><author>Tran, Bich ; Armstrong, Bruce K ; Carlin, John B ; Ebeling, Peter R ; English, Dallas R ; Kimlin, Michael G ; Rahman, Bayzidur ; van der Pols, Jolieke C ; Venn, Alison ; Gebski, Val ; Whiteman, David C ; Webb, Penelope M ; Neale, Rachel E</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c403t-d3999e28efa9df143c0606be9280308483cba31572f61e9be631046d15010fb83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Australia - epidemiology</topic><topic>Biological and medical sciences</topic><topic>Chronic Disease - epidemiology</topic><topic>Chronic Disease - mortality</topic><topic>Dietary Supplements</topic><topic>Double-Blind Method</topic><topic>Endocrinopathies</topic><topic>Feeding. Feeding behavior</topic><topic>Female</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Neoplasms - epidemiology</topic><topic>Neoplasms - mortality</topic><topic>Neoplasms - prevention & control</topic><topic>Patient Selection</topic><topic>Pilot Projects</topic><topic>Placebos</topic><topic>Population</topic><topic>Survival Analysis</topic><topic>Vertebrates: anatomy and physiology, studies on body, several organs or systems</topic><topic>Vertebrates: endocrinology</topic><topic>Vitamin D - administration & dosage</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tran, Bich</creatorcontrib><creatorcontrib>Armstrong, Bruce K</creatorcontrib><creatorcontrib>Carlin, John B</creatorcontrib><creatorcontrib>Ebeling, Peter R</creatorcontrib><creatorcontrib>English, Dallas R</creatorcontrib><creatorcontrib>Kimlin, Michael G</creatorcontrib><creatorcontrib>Rahman, Bayzidur</creatorcontrib><creatorcontrib>van der Pols, Jolieke C</creatorcontrib><creatorcontrib>Venn, Alison</creatorcontrib><creatorcontrib>Gebski, Val</creatorcontrib><creatorcontrib>Whiteman, David C</creatorcontrib><creatorcontrib>Webb, Penelope M</creatorcontrib><creatorcontrib>Neale, Rachel E</creatorcontrib><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>MEDLINE - Academic</collection><jtitle>The journal of clinical endocrinology and metabolism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tran, Bich</au><au>Armstrong, Bruce K</au><au>Carlin, John B</au><au>Ebeling, Peter R</au><au>English, Dallas R</au><au>Kimlin, Michael G</au><au>Rahman, Bayzidur</au><au>van der Pols, Jolieke C</au><au>Venn, Alison</au><au>Gebski, Val</au><au>Whiteman, David C</au><au>Webb, Penelope M</au><au>Neale, Rachel E</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Recruitment and Results of a Pilot Trial of Vitamin D Supplementation in the General Population of Australia</atitle><jtitle>The journal of clinical endocrinology and metabolism</jtitle><addtitle>J Clin Endocrinol Metab</addtitle><date>2012-12-01</date><risdate>2012</risdate><volume>97</volume><issue>12</issue><spage>4473</spage><epage>4480</epage><pages>4473-4480</pages><issn>0021-972X</issn><eissn>1945-7197</eissn><coden>JCEMAZ</coden><abstract>Context:
The benefits of high serum levels of 25-hydroxyvitamin D [25(OH)D] are unclear. Trials are needed to establish an appropriate evidence base.
Objective:
We plan to conduct a large-scale trial of vitamin D supplementation for the reduction of cancer incidence and overall mortality and report here the methods and results of a pilot trial established to inform its design.
Design:
Pilot D-Health was a randomized trial carried out in a general community setting with 12 months intervention and follow-up.
Participants:
Participants were 60- to 84-yr-old residents of one of the four eastern Australian states who did not have any vitamin D-related disorders and who were not taking more than 400 IU supplementary vitamin D per day. A total of 644 participants were randomized, and 615 completed the study (two persons withdrew because of nonserious adverse events).
Interventions:
The interventions were monthly doses of placebo or 30,000 or 60,000 IU vitamin D3.
Main Outcomes:
The main outcomes were the recruitment rate and changes in serum 25(OH)D.
Results:
Ten percent of those approached were recruited. At baseline, the mean 25(OH)D was 42 nmol/liter in all three study arms. The mean change in 25(OH)D in the placebo group was 0.12 nmol/liter, compared with changes of 22 and 36 nmol/liter in the 30,000- and 60,000-IU groups, respectively.
Conclusions:
The D-Health pilot has shown that a large trial is feasible in Australia and that a dose of 2000 IU/d will be needed to ensure that a large proportion of the population reaches the target serum 25(OH)D level.</abstract><cop>Bethesda, MD</cop><pub>Endocrine Society</pub><pmid>23066119</pmid><doi>10.1210/jc.2012-2682</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0021-972X |
| ispartof | The journal of clinical endocrinology and metabolism, 2012-12, Vol.97 (12), p.4473-4480 |
| issn | 0021-972X 1945-7197 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1237506310 |
| source | MEDLINE; Journals@Ovid Complete; Oxford University Press Journals All Titles (1996-Current); EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | Aged Aged, 80 and over Australia - epidemiology Biological and medical sciences Chronic Disease - epidemiology Chronic Disease - mortality Dietary Supplements Double-Blind Method Endocrinopathies Feeding. Feeding behavior Female Fundamental and applied biological sciences. Psychology Humans Male Medical sciences Middle Aged Neoplasms - epidemiology Neoplasms - mortality Neoplasms - prevention & control Patient Selection Pilot Projects Placebos Population Survival Analysis Vertebrates: anatomy and physiology, studies on body, several organs or systems Vertebrates: endocrinology Vitamin D - administration & dosage |
| title | Recruitment and Results of a Pilot Trial of Vitamin D Supplementation in the General Population of Australia |
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