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Design Features of Randomized Clinical Trials of Vitamin D and Falls: A Systematic Review
Recent guidelines have advocated against the use of vitamin D supplementation as a means to prevent falls in older adults. However, meta-analyses of the available trials have reached divergent conclusions, and the key design features of these trials have not been well characterized. We conducted a s...
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Published in: | Nutrients 2018-07, Vol.10 (8), p.964 |
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description | Recent guidelines have advocated against the use of vitamin D supplementation as a means to prevent falls in older adults. However, meta-analyses of the available trials have reached divergent conclusions, and the key design features of these trials have not been well characterized. We conducted a systematic review of 30 randomized trials that reported the effects of vitamin D supplements on falls. Trials were identified by reviewing references of published meta-analyses and updated with a systematic PubMed search. We assessed three key design features: (1) recruitment of participants with vitamin D deficiency or insufficiency; (2) provision of daily oral vitamin D supplementation; and (3) utilization of highly sensitive at-event falls ascertainment. The trials enrolled a median of 337 (IQR: 170-1864) participants. Four (13.3%) trials restricted enrollment to those who were at least vitamin D insufficient, 18 (60.0%) included at least one arm providing daily supplementation, and 16 (53.3%) used at-event reporting. There was substantial heterogeneity between trials, and no single trial incorporated all three key design features. Rather than concluding that vitamin D is ineffective as a means to prevent falls, these findings suggest that existing trial evidence is insufficient to guide recommendations on the use of vitamin D supplements to prevent falls. |
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However, meta-analyses of the available trials have reached divergent conclusions, and the key design features of these trials have not been well characterized. We conducted a systematic review of 30 randomized trials that reported the effects of vitamin D supplements on falls. Trials were identified by reviewing references of published meta-analyses and updated with a systematic PubMed search. We assessed three key design features: (1) recruitment of participants with vitamin D deficiency or insufficiency; (2) provision of daily oral vitamin D supplementation; and (3) utilization of highly sensitive at-event falls ascertainment. The trials enrolled a median of 337 (IQR: 170-1864) participants. Four (13.3%) trials restricted enrollment to those who were at least vitamin D insufficient, 18 (60.0%) included at least one arm providing daily supplementation, and 16 (53.3%) used at-event reporting. There was substantial heterogeneity between trials, and no single trial incorporated all three key design features. Rather than concluding that vitamin D is ineffective as a means to prevent falls, these findings suggest that existing trial evidence is insufficient to guide recommendations on the use of vitamin D supplements to prevent falls.</description><identifier>ISSN: 2072-6643</identifier><identifier>EISSN: 2072-6643</identifier><identifier>DOI: 10.3390/nu10080964</identifier><identifier>PMID: 30049963</identifier><language>eng</language><publisher>Switzerland: MDPI AG</publisher><subject>Accidental Falls - prevention & control ; Adults ; Age Factors ; Aged ; Clinical trials ; Design ; Dietary supplements ; Dietary Supplements - adverse effects ; Evidence-Based Medicine - methods ; Falls ; falls prevention ; Female ; Heterogeneity ; Humans ; Injury prevention ; Male ; Medical research ; Meta-analysis ; Older people ; Protective Factors ; Randomization ; Randomized Controlled Trials as Topic - methods ; Research Design ; Review ; Risk Factors ; Systematic review ; Treatment Outcome ; trials ; Upgrading ; Vitamin D ; Vitamin D - administration & dosage ; Vitamin D - adverse effects ; Vitamin D - blood ; Vitamin D Deficiency - blood ; Vitamin D Deficiency - diagnosis ; Vitamin D Deficiency - drug therapy ; Vitamin D Deficiency - epidemiology ; Vitamin deficiency</subject><ispartof>Nutrients, 2018-07, Vol.10 (8), p.964</ispartof><rights>2018. This work is licensed under http://creativecommons.org/licenses/by/3.0/ (the “License”). 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However, meta-analyses of the available trials have reached divergent conclusions, and the key design features of these trials have not been well characterized. We conducted a systematic review of 30 randomized trials that reported the effects of vitamin D supplements on falls. Trials were identified by reviewing references of published meta-analyses and updated with a systematic PubMed search. We assessed three key design features: (1) recruitment of participants with vitamin D deficiency or insufficiency; (2) provision of daily oral vitamin D supplementation; and (3) utilization of highly sensitive at-event falls ascertainment. The trials enrolled a median of 337 (IQR: 170-1864) participants. Four (13.3%) trials restricted enrollment to those who were at least vitamin D insufficient, 18 (60.0%) included at least one arm providing daily supplementation, and 16 (53.3%) used at-event reporting. 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Rather than concluding that vitamin D is ineffective as a means to prevent falls, these findings suggest that existing trial evidence is insufficient to guide recommendations on the use of vitamin D supplements to prevent falls.</description><subject>Accidental Falls - prevention & control</subject><subject>Adults</subject><subject>Age Factors</subject><subject>Aged</subject><subject>Clinical trials</subject><subject>Design</subject><subject>Dietary supplements</subject><subject>Dietary Supplements - adverse effects</subject><subject>Evidence-Based Medicine - methods</subject><subject>Falls</subject><subject>falls prevention</subject><subject>Female</subject><subject>Heterogeneity</subject><subject>Humans</subject><subject>Injury prevention</subject><subject>Male</subject><subject>Medical research</subject><subject>Meta-analysis</subject><subject>Older people</subject><subject>Protective Factors</subject><subject>Randomization</subject><subject>Randomized Controlled Trials as Topic - methods</subject><subject>Research Design</subject><subject>Review</subject><subject>Risk Factors</subject><subject>Systematic review</subject><subject>Treatment Outcome</subject><subject>trials</subject><subject>Upgrading</subject><subject>Vitamin D</subject><subject>Vitamin D - administration & dosage</subject><subject>Vitamin D - adverse effects</subject><subject>Vitamin D - blood</subject><subject>Vitamin D Deficiency - blood</subject><subject>Vitamin D Deficiency - diagnosis</subject><subject>Vitamin D Deficiency - drug therapy</subject><subject>Vitamin D Deficiency - epidemiology</subject><subject>Vitamin deficiency</subject><issn>2072-6643</issn><issn>2072-6643</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>PIMPY</sourceid><sourceid>DOA</sourceid><recordid>eNpdkl1rFDEUhgdRbKm98QdIwBsRVvOdiRdC2bq2UCjUKngVMsnZNctMUpOZSvvrm-62tW0ukpDz5OElJ03zluBPjGn8OU4E4xZryV80uxQrOpOSs5eP9jvNfilrfDsUVpK9bnYYxlxryXab34dQwiqiBdhxylBQWqIzG30awjV4NO9DDM726DwH22-qv8JohxDRIaoYWti-L1_QAfpxVUYY7BgcOoPLAP_eNK-W9Qrs3617zc_Ft_P50ezk9Pvx_OBk5rii40x2mgATdQLSEiI8Vq5dtgQoOE2tlV5YSxTzThDohBbgMZFSeEG5UESwveZ46_XJrs1FDoPNVybZYDYHKa-MzTVWD8ZzRgXxHZWu5VRVO8OgO0uBd9R3vLq-bl0XUzeAdxDHbPsn0qeVGP6YVbo0siZXWFfBhztBTn8nKKMZQnHQ9zZCmoqpTWlFK3UrK_r-GbpOU471qQwluFKt3gg_bimXUykZlg9hCDa3H8D8_wAVfvc4_gN63252A4N4qXE</recordid><startdate>20180726</startdate><enddate>20180726</enddate><creator>Tang, Olive</creator><creator>Juraschek, Stephen P</creator><creator>Appel, Lawrence J</creator><general>MDPI AG</general><general>MDPI</general><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>3V.</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0002-0673-6823</orcidid></search><sort><creationdate>20180726</creationdate><title>Design Features of Randomized Clinical Trials of Vitamin D and Falls: A Systematic Review</title><author>Tang, Olive ; Juraschek, Stephen P ; Appel, Lawrence J</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c472t-6b91e3591ee18115d07c8f81e2ec92aa6d5aa173dc51eb595ed01665d52457153</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Accidental Falls - prevention & control</topic><topic>Adults</topic><topic>Age Factors</topic><topic>Aged</topic><topic>Clinical trials</topic><topic>Design</topic><topic>Dietary supplements</topic><topic>Dietary Supplements - adverse effects</topic><topic>Evidence-Based Medicine - methods</topic><topic>Falls</topic><topic>falls prevention</topic><topic>Female</topic><topic>Heterogeneity</topic><topic>Humans</topic><topic>Injury prevention</topic><topic>Male</topic><topic>Medical research</topic><topic>Meta-analysis</topic><topic>Older people</topic><topic>Protective Factors</topic><topic>Randomization</topic><topic>Randomized Controlled Trials as Topic - methods</topic><topic>Research Design</topic><topic>Review</topic><topic>Risk Factors</topic><topic>Systematic review</topic><topic>Treatment Outcome</topic><topic>trials</topic><topic>Upgrading</topic><topic>Vitamin D</topic><topic>Vitamin D - administration & dosage</topic><topic>Vitamin D - adverse effects</topic><topic>Vitamin D - blood</topic><topic>Vitamin D Deficiency - blood</topic><topic>Vitamin D Deficiency - diagnosis</topic><topic>Vitamin D Deficiency - drug therapy</topic><topic>Vitamin D Deficiency - epidemiology</topic><topic>Vitamin deficiency</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tang, Olive</creatorcontrib><creatorcontrib>Juraschek, Stephen P</creatorcontrib><creatorcontrib>Appel, Lawrence J</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Physical Education Index</collection><collection>ProQuest Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>Nutrients</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tang, Olive</au><au>Juraschek, Stephen P</au><au>Appel, Lawrence J</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Design Features of Randomized Clinical Trials of Vitamin D and Falls: A Systematic Review</atitle><jtitle>Nutrients</jtitle><addtitle>Nutrients</addtitle><date>2018-07-26</date><risdate>2018</risdate><volume>10</volume><issue>8</issue><spage>964</spage><pages>964-</pages><issn>2072-6643</issn><eissn>2072-6643</eissn><abstract>Recent guidelines have advocated against the use of vitamin D supplementation as a means to prevent falls in older adults. 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subjects | Accidental Falls - prevention & control Adults Age Factors Aged Clinical trials Design Dietary supplements Dietary Supplements - adverse effects Evidence-Based Medicine - methods Falls falls prevention Female Heterogeneity Humans Injury prevention Male Medical research Meta-analysis Older people Protective Factors Randomization Randomized Controlled Trials as Topic - methods Research Design Review Risk Factors Systematic review Treatment Outcome trials Upgrading Vitamin D Vitamin D - administration & dosage Vitamin D - adverse effects Vitamin D - blood Vitamin D Deficiency - blood Vitamin D Deficiency - diagnosis Vitamin D Deficiency - drug therapy Vitamin D Deficiency - epidemiology Vitamin deficiency |
title | Design Features of Randomized Clinical Trials of Vitamin D and Falls: A Systematic Review |
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