The Multi-Ethnic Study of Atherosclerosis individual response to vitamin D trial: Building a randomized clinical trial into an observational cohort study
The INdividual response to VITamin D (INVITe) trial was a randomized, placebo-controlled, parallel group trial of vitamin D3 supplementation (2000 IU daily) designed to determine clinical and genetic characteristics that modify the response to vitamin D supplementation. To enhance internal and exter...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
de Boer, Ian H. [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2021transfer abstract |
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| Übergeordnetes Werk: |
Enthalten in: Quality properties and antioxidant activity of seven strawberry ( - Chaves, Vitor C. ELSEVIER, 2017, design, methods and analysis, Amsterdam [u.a.] |
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| Übergeordnetes Werk: |
volume:103 ; year:2021 ; pages:0 |
| Links: |
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| DOI / URN: |
10.1016/j.cct.2021.106318 |
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| 520 | |a The INdividual response to VITamin D (INVITe) trial was a randomized, placebo-controlled, parallel group trial of vitamin D3 supplementation (2000 IU daily) designed to determine clinical and genetic characteristics that modify the response to vitamin D supplementation. To enhance internal and external validity and reduce cost, the INVITe trial was nested within the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing prospective observational cohort study. The INVITe trial enrolled a community-based population of 666 racially and ethnically diverse participants from January 2017 to April 2019. This represents 30% of 2210 MESA participants approached for screening, and 96% of those found to be eligible. Barriers to enrollment included delayed initiation of the trial relative to scheduled MESA study visits, a lower number of available MESA participants than expected, and a high prevalence (18%) of high-dose vitamin D supplementation (>1000 IU daily, an exclusion criterion). The final study visit was attended by 611 participants (92%), and median adherence was 98%. Our experience suggests that integration of a randomized trial into an existing observational cohort study may leverage strengths of the source population and enhance enrollment, retention, and adherence, although with limited enrollment capacity. The INVITe trial will use rigorously-collected data to advance understanding of individual determinants of vitamin D response. | ||
| 520 | |a The INdividual response to VITamin D (INVITe) trial was a randomized, placebo-controlled, parallel group trial of vitamin D3 supplementation (2000 IU daily) designed to determine clinical and genetic characteristics that modify the response to vitamin D supplementation. To enhance internal and external validity and reduce cost, the INVITe trial was nested within the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing prospective observational cohort study. The INVITe trial enrolled a community-based population of 666 racially and ethnically diverse participants from January 2017 to April 2019. This represents 30% of 2210 MESA participants approached for screening, and 96% of those found to be eligible. Barriers to enrollment included delayed initiation of the trial relative to scheduled MESA study visits, a lower number of available MESA participants than expected, and a high prevalence (18%) of high-dose vitamin D supplementation (>1000 IU daily, an exclusion criterion). The final study visit was attended by 611 participants (92%), and median adherence was 98%. Our experience suggests that integration of a randomized trial into an existing observational cohort study may leverage strengths of the source population and enhance enrollment, retention, and adherence, although with limited enrollment capacity. The INVITe trial will use rigorously-collected data to advance understanding of individual determinants of vitamin D response. | ||
| 700 | 1 | |a Prince, David K. |4 oth | |
| 700 | 1 | |a Williams, Kayleen |4 oth | |
| 700 | 1 | |a Allen, Norrina B. |4 oth | |
| 700 | 1 | |a Burke, Gregory L. |4 oth | |
| 700 | 1 | |a Hoofnagle, Andrew N. |4 oth | |
| 700 | 1 | |a Hsu, Simon |4 oth | |
| 700 | 1 | |a Li, Xiaohui |4 oth | |
| 700 | 1 | |a Liu, Kiang J. |4 oth | |
| 700 | 1 | |a McClelland, Robyn L. |4 oth | |
| 700 | 1 | |a Michos, Erin D. |4 oth | |
| 700 | 1 | |a Psaty, Bruce M. |4 oth | |
| 700 | 1 | |a Shea, Steven J. |4 oth | |
| 700 | 1 | |a Rice, Kenneth M. |4 oth | |
| 700 | 1 | |a Rotter, Jerome I. |4 oth | |
| 700 | 1 | |a Siscovick, David S. |4 oth | |
| 700 | 1 | |a Tracy, Russell P. |4 oth | |
| 700 | 1 | |a Watson, Karol E. |4 oth | |
| 700 | 1 | |a Kestenbaum, Bryan R. |4 oth | |
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10.1016/j.cct.2021.106318 doi /cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000001373.pica (DE-627)ELV053804066 (ELSEVIER)S1551-7144(21)00054-9 DE-627 ger DE-627 rakwb eng 630 640 VZ 48.50 bkl de Boer, Ian H. verfasserin aut The Multi-Ethnic Study of Atherosclerosis individual response to vitamin D trial: Building a randomized clinical trial into an observational cohort study 2021transfer abstract nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier The INdividual response to VITamin D (INVITe) trial was a randomized, placebo-controlled, parallel group trial of vitamin D3 supplementation (2000 IU daily) designed to determine clinical and genetic characteristics that modify the response to vitamin D supplementation. To enhance internal and external validity and reduce cost, the INVITe trial was nested within the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing prospective observational cohort study. The INVITe trial enrolled a community-based population of 666 racially and ethnically diverse participants from January 2017 to April 2019. This represents 30% of 2210 MESA participants approached for screening, and 96% of those found to be eligible. Barriers to enrollment included delayed initiation of the trial relative to scheduled MESA study visits, a lower number of available MESA participants than expected, and a high prevalence (18%) of high-dose vitamin D supplementation (>1000 IU daily, an exclusion criterion). The final study visit was attended by 611 participants (92%), and median adherence was 98%. Our experience suggests that integration of a randomized trial into an existing observational cohort study may leverage strengths of the source population and enhance enrollment, retention, and adherence, although with limited enrollment capacity. The INVITe trial will use rigorously-collected data to advance understanding of individual determinants of vitamin D response. The INdividual response to VITamin D (INVITe) trial was a randomized, placebo-controlled, parallel group trial of vitamin D3 supplementation (2000 IU daily) designed to determine clinical and genetic characteristics that modify the response to vitamin D supplementation. To enhance internal and external validity and reduce cost, the INVITe trial was nested within the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing prospective observational cohort study. The INVITe trial enrolled a community-based population of 666 racially and ethnically diverse participants from January 2017 to April 2019. This represents 30% of 2210 MESA participants approached for screening, and 96% of those found to be eligible. Barriers to enrollment included delayed initiation of the trial relative to scheduled MESA study visits, a lower number of available MESA participants than expected, and a high prevalence (18%) of high-dose vitamin D supplementation (>1000 IU daily, an exclusion criterion). The final study visit was attended by 611 participants (92%), and median adherence was 98%. Our experience suggests that integration of a randomized trial into an existing observational cohort study may leverage strengths of the source population and enhance enrollment, retention, and adherence, although with limited enrollment capacity. The INVITe trial will use rigorously-collected data to advance understanding of individual determinants of vitamin D response. Prince, David K. oth Williams, Kayleen oth Allen, Norrina B. oth Burke, Gregory L. oth Hoofnagle, Andrew N. oth Hsu, Simon oth Li, Xiaohui oth Liu, Kiang J. oth McClelland, Robyn L. oth Michos, Erin D. oth Psaty, Bruce M. oth Shea, Steven J. oth Rice, Kenneth M. oth Rotter, Jerome I. oth Siscovick, David S. oth Tracy, Russell P. oth Watson, Karol E. oth Kestenbaum, Bryan R. oth Enthalten in Elsevier Science Chaves, Vitor C. ELSEVIER Quality properties and antioxidant activity of seven strawberry ( 2017 design, methods and analysis Amsterdam [u.a.] (DE-627)ELV000409197 volume:103 year:2021 pages:0 https://doi.org/10.1016/j.cct.2021.106318 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 48.50 Pflanzenproduktion: Allgemeines VZ AR 103 2021 0 |
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10.1016/j.cct.2021.106318 doi /cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000001373.pica (DE-627)ELV053804066 (ELSEVIER)S1551-7144(21)00054-9 DE-627 ger DE-627 rakwb eng 630 640 VZ 48.50 bkl de Boer, Ian H. verfasserin aut The Multi-Ethnic Study of Atherosclerosis individual response to vitamin D trial: Building a randomized clinical trial into an observational cohort study 2021transfer abstract nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier The INdividual response to VITamin D (INVITe) trial was a randomized, placebo-controlled, parallel group trial of vitamin D3 supplementation (2000 IU daily) designed to determine clinical and genetic characteristics that modify the response to vitamin D supplementation. To enhance internal and external validity and reduce cost, the INVITe trial was nested within the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing prospective observational cohort study. The INVITe trial enrolled a community-based population of 666 racially and ethnically diverse participants from January 2017 to April 2019. This represents 30% of 2210 MESA participants approached for screening, and 96% of those found to be eligible. Barriers to enrollment included delayed initiation of the trial relative to scheduled MESA study visits, a lower number of available MESA participants than expected, and a high prevalence (18%) of high-dose vitamin D supplementation (>1000 IU daily, an exclusion criterion). The final study visit was attended by 611 participants (92%), and median adherence was 98%. Our experience suggests that integration of a randomized trial into an existing observational cohort study may leverage strengths of the source population and enhance enrollment, retention, and adherence, although with limited enrollment capacity. The INVITe trial will use rigorously-collected data to advance understanding of individual determinants of vitamin D response. The INdividual response to VITamin D (INVITe) trial was a randomized, placebo-controlled, parallel group trial of vitamin D3 supplementation (2000 IU daily) designed to determine clinical and genetic characteristics that modify the response to vitamin D supplementation. To enhance internal and external validity and reduce cost, the INVITe trial was nested within the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing prospective observational cohort study. The INVITe trial enrolled a community-based population of 666 racially and ethnically diverse participants from January 2017 to April 2019. This represents 30% of 2210 MESA participants approached for screening, and 96% of those found to be eligible. Barriers to enrollment included delayed initiation of the trial relative to scheduled MESA study visits, a lower number of available MESA participants than expected, and a high prevalence (18%) of high-dose vitamin D supplementation (>1000 IU daily, an exclusion criterion). The final study visit was attended by 611 participants (92%), and median adherence was 98%. Our experience suggests that integration of a randomized trial into an existing observational cohort study may leverage strengths of the source population and enhance enrollment, retention, and adherence, although with limited enrollment capacity. The INVITe trial will use rigorously-collected data to advance understanding of individual determinants of vitamin D response. Prince, David K. oth Williams, Kayleen oth Allen, Norrina B. oth Burke, Gregory L. oth Hoofnagle, Andrew N. oth Hsu, Simon oth Li, Xiaohui oth Liu, Kiang J. oth McClelland, Robyn L. oth Michos, Erin D. oth Psaty, Bruce M. oth Shea, Steven J. oth Rice, Kenneth M. oth Rotter, Jerome I. oth Siscovick, David S. oth Tracy, Russell P. oth Watson, Karol E. oth Kestenbaum, Bryan R. oth Enthalten in Elsevier Science Chaves, Vitor C. ELSEVIER Quality properties and antioxidant activity of seven strawberry ( 2017 design, methods and analysis Amsterdam [u.a.] (DE-627)ELV000409197 volume:103 year:2021 pages:0 https://doi.org/10.1016/j.cct.2021.106318 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 48.50 Pflanzenproduktion: Allgemeines VZ AR 103 2021 0 |
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10.1016/j.cct.2021.106318 doi /cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000001373.pica (DE-627)ELV053804066 (ELSEVIER)S1551-7144(21)00054-9 DE-627 ger DE-627 rakwb eng 630 640 VZ 48.50 bkl de Boer, Ian H. verfasserin aut The Multi-Ethnic Study of Atherosclerosis individual response to vitamin D trial: Building a randomized clinical trial into an observational cohort study 2021transfer abstract nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier The INdividual response to VITamin D (INVITe) trial was a randomized, placebo-controlled, parallel group trial of vitamin D3 supplementation (2000 IU daily) designed to determine clinical and genetic characteristics that modify the response to vitamin D supplementation. To enhance internal and external validity and reduce cost, the INVITe trial was nested within the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing prospective observational cohort study. The INVITe trial enrolled a community-based population of 666 racially and ethnically diverse participants from January 2017 to April 2019. This represents 30% of 2210 MESA participants approached for screening, and 96% of those found to be eligible. Barriers to enrollment included delayed initiation of the trial relative to scheduled MESA study visits, a lower number of available MESA participants than expected, and a high prevalence (18%) of high-dose vitamin D supplementation (>1000 IU daily, an exclusion criterion). The final study visit was attended by 611 participants (92%), and median adherence was 98%. Our experience suggests that integration of a randomized trial into an existing observational cohort study may leverage strengths of the source population and enhance enrollment, retention, and adherence, although with limited enrollment capacity. The INVITe trial will use rigorously-collected data to advance understanding of individual determinants of vitamin D response. The INdividual response to VITamin D (INVITe) trial was a randomized, placebo-controlled, parallel group trial of vitamin D3 supplementation (2000 IU daily) designed to determine clinical and genetic characteristics that modify the response to vitamin D supplementation. To enhance internal and external validity and reduce cost, the INVITe trial was nested within the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing prospective observational cohort study. The INVITe trial enrolled a community-based population of 666 racially and ethnically diverse participants from January 2017 to April 2019. This represents 30% of 2210 MESA participants approached for screening, and 96% of those found to be eligible. Barriers to enrollment included delayed initiation of the trial relative to scheduled MESA study visits, a lower number of available MESA participants than expected, and a high prevalence (18%) of high-dose vitamin D supplementation (>1000 IU daily, an exclusion criterion). The final study visit was attended by 611 participants (92%), and median adherence was 98%. Our experience suggests that integration of a randomized trial into an existing observational cohort study may leverage strengths of the source population and enhance enrollment, retention, and adherence, although with limited enrollment capacity. The INVITe trial will use rigorously-collected data to advance understanding of individual determinants of vitamin D response. Prince, David K. oth Williams, Kayleen oth Allen, Norrina B. oth Burke, Gregory L. oth Hoofnagle, Andrew N. oth Hsu, Simon oth Li, Xiaohui oth Liu, Kiang J. oth McClelland, Robyn L. oth Michos, Erin D. oth Psaty, Bruce M. oth Shea, Steven J. oth Rice, Kenneth M. oth Rotter, Jerome I. oth Siscovick, David S. oth Tracy, Russell P. oth Watson, Karol E. oth Kestenbaum, Bryan R. oth Enthalten in Elsevier Science Chaves, Vitor C. ELSEVIER Quality properties and antioxidant activity of seven strawberry ( 2017 design, methods and analysis Amsterdam [u.a.] (DE-627)ELV000409197 volume:103 year:2021 pages:0 https://doi.org/10.1016/j.cct.2021.106318 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 48.50 Pflanzenproduktion: Allgemeines VZ AR 103 2021 0 |
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10.1016/j.cct.2021.106318 doi /cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000001373.pica (DE-627)ELV053804066 (ELSEVIER)S1551-7144(21)00054-9 DE-627 ger DE-627 rakwb eng 630 640 VZ 48.50 bkl de Boer, Ian H. verfasserin aut The Multi-Ethnic Study of Atherosclerosis individual response to vitamin D trial: Building a randomized clinical trial into an observational cohort study 2021transfer abstract nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier The INdividual response to VITamin D (INVITe) trial was a randomized, placebo-controlled, parallel group trial of vitamin D3 supplementation (2000 IU daily) designed to determine clinical and genetic characteristics that modify the response to vitamin D supplementation. To enhance internal and external validity and reduce cost, the INVITe trial was nested within the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing prospective observational cohort study. The INVITe trial enrolled a community-based population of 666 racially and ethnically diverse participants from January 2017 to April 2019. This represents 30% of 2210 MESA participants approached for screening, and 96% of those found to be eligible. Barriers to enrollment included delayed initiation of the trial relative to scheduled MESA study visits, a lower number of available MESA participants than expected, and a high prevalence (18%) of high-dose vitamin D supplementation (>1000 IU daily, an exclusion criterion). The final study visit was attended by 611 participants (92%), and median adherence was 98%. Our experience suggests that integration of a randomized trial into an existing observational cohort study may leverage strengths of the source population and enhance enrollment, retention, and adherence, although with limited enrollment capacity. The INVITe trial will use rigorously-collected data to advance understanding of individual determinants of vitamin D response. The INdividual response to VITamin D (INVITe) trial was a randomized, placebo-controlled, parallel group trial of vitamin D3 supplementation (2000 IU daily) designed to determine clinical and genetic characteristics that modify the response to vitamin D supplementation. To enhance internal and external validity and reduce cost, the INVITe trial was nested within the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing prospective observational cohort study. The INVITe trial enrolled a community-based population of 666 racially and ethnically diverse participants from January 2017 to April 2019. This represents 30% of 2210 MESA participants approached for screening, and 96% of those found to be eligible. Barriers to enrollment included delayed initiation of the trial relative to scheduled MESA study visits, a lower number of available MESA participants than expected, and a high prevalence (18%) of high-dose vitamin D supplementation (>1000 IU daily, an exclusion criterion). The final study visit was attended by 611 participants (92%), and median adherence was 98%. Our experience suggests that integration of a randomized trial into an existing observational cohort study may leverage strengths of the source population and enhance enrollment, retention, and adherence, although with limited enrollment capacity. The INVITe trial will use rigorously-collected data to advance understanding of individual determinants of vitamin D response. Prince, David K. oth Williams, Kayleen oth Allen, Norrina B. oth Burke, Gregory L. oth Hoofnagle, Andrew N. oth Hsu, Simon oth Li, Xiaohui oth Liu, Kiang J. oth McClelland, Robyn L. oth Michos, Erin D. oth Psaty, Bruce M. oth Shea, Steven J. oth Rice, Kenneth M. oth Rotter, Jerome I. oth Siscovick, David S. oth Tracy, Russell P. oth Watson, Karol E. oth Kestenbaum, Bryan R. oth Enthalten in Elsevier Science Chaves, Vitor C. ELSEVIER Quality properties and antioxidant activity of seven strawberry ( 2017 design, methods and analysis Amsterdam [u.a.] (DE-627)ELV000409197 volume:103 year:2021 pages:0 https://doi.org/10.1016/j.cct.2021.106318 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 48.50 Pflanzenproduktion: Allgemeines VZ AR 103 2021 0 |
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10.1016/j.cct.2021.106318 doi /cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000001373.pica (DE-627)ELV053804066 (ELSEVIER)S1551-7144(21)00054-9 DE-627 ger DE-627 rakwb eng 630 640 VZ 48.50 bkl de Boer, Ian H. verfasserin aut The Multi-Ethnic Study of Atherosclerosis individual response to vitamin D trial: Building a randomized clinical trial into an observational cohort study 2021transfer abstract nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier The INdividual response to VITamin D (INVITe) trial was a randomized, placebo-controlled, parallel group trial of vitamin D3 supplementation (2000 IU daily) designed to determine clinical and genetic characteristics that modify the response to vitamin D supplementation. To enhance internal and external validity and reduce cost, the INVITe trial was nested within the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing prospective observational cohort study. The INVITe trial enrolled a community-based population of 666 racially and ethnically diverse participants from January 2017 to April 2019. This represents 30% of 2210 MESA participants approached for screening, and 96% of those found to be eligible. Barriers to enrollment included delayed initiation of the trial relative to scheduled MESA study visits, a lower number of available MESA participants than expected, and a high prevalence (18%) of high-dose vitamin D supplementation (>1000 IU daily, an exclusion criterion). The final study visit was attended by 611 participants (92%), and median adherence was 98%. Our experience suggests that integration of a randomized trial into an existing observational cohort study may leverage strengths of the source population and enhance enrollment, retention, and adherence, although with limited enrollment capacity. The INVITe trial will use rigorously-collected data to advance understanding of individual determinants of vitamin D response. The INdividual response to VITamin D (INVITe) trial was a randomized, placebo-controlled, parallel group trial of vitamin D3 supplementation (2000 IU daily) designed to determine clinical and genetic characteristics that modify the response to vitamin D supplementation. To enhance internal and external validity and reduce cost, the INVITe trial was nested within the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing prospective observational cohort study. The INVITe trial enrolled a community-based population of 666 racially and ethnically diverse participants from January 2017 to April 2019. This represents 30% of 2210 MESA participants approached for screening, and 96% of those found to be eligible. Barriers to enrollment included delayed initiation of the trial relative to scheduled MESA study visits, a lower number of available MESA participants than expected, and a high prevalence (18%) of high-dose vitamin D supplementation (>1000 IU daily, an exclusion criterion). The final study visit was attended by 611 participants (92%), and median adherence was 98%. Our experience suggests that integration of a randomized trial into an existing observational cohort study may leverage strengths of the source population and enhance enrollment, retention, and adherence, although with limited enrollment capacity. The INVITe trial will use rigorously-collected data to advance understanding of individual determinants of vitamin D response. Prince, David K. oth Williams, Kayleen oth Allen, Norrina B. oth Burke, Gregory L. oth Hoofnagle, Andrew N. oth Hsu, Simon oth Li, Xiaohui oth Liu, Kiang J. oth McClelland, Robyn L. oth Michos, Erin D. oth Psaty, Bruce M. oth Shea, Steven J. oth Rice, Kenneth M. oth Rotter, Jerome I. oth Siscovick, David S. oth Tracy, Russell P. oth Watson, Karol E. oth Kestenbaum, Bryan R. oth Enthalten in Elsevier Science Chaves, Vitor C. ELSEVIER Quality properties and antioxidant activity of seven strawberry ( 2017 design, methods and analysis Amsterdam [u.a.] (DE-627)ELV000409197 volume:103 year:2021 pages:0 https://doi.org/10.1016/j.cct.2021.106318 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 48.50 Pflanzenproduktion: Allgemeines VZ AR 103 2021 0 |
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The Multi-Ethnic Study of Atherosclerosis individual response to vitamin D trial: Building a randomized clinical trial into an observational cohort study |
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The INdividual response to VITamin D (INVITe) trial was a randomized, placebo-controlled, parallel group trial of vitamin D3 supplementation (2000 IU daily) designed to determine clinical and genetic characteristics that modify the response to vitamin D supplementation. To enhance internal and external validity and reduce cost, the INVITe trial was nested within the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing prospective observational cohort study. The INVITe trial enrolled a community-based population of 666 racially and ethnically diverse participants from January 2017 to April 2019. This represents 30% of 2210 MESA participants approached for screening, and 96% of those found to be eligible. Barriers to enrollment included delayed initiation of the trial relative to scheduled MESA study visits, a lower number of available MESA participants than expected, and a high prevalence (18%) of high-dose vitamin D supplementation (>1000 IU daily, an exclusion criterion). The final study visit was attended by 611 participants (92%), and median adherence was 98%. Our experience suggests that integration of a randomized trial into an existing observational cohort study may leverage strengths of the source population and enhance enrollment, retention, and adherence, although with limited enrollment capacity. The INVITe trial will use rigorously-collected data to advance understanding of individual determinants of vitamin D response. |
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The INdividual response to VITamin D (INVITe) trial was a randomized, placebo-controlled, parallel group trial of vitamin D3 supplementation (2000 IU daily) designed to determine clinical and genetic characteristics that modify the response to vitamin D supplementation. To enhance internal and external validity and reduce cost, the INVITe trial was nested within the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing prospective observational cohort study. The INVITe trial enrolled a community-based population of 666 racially and ethnically diverse participants from January 2017 to April 2019. This represents 30% of 2210 MESA participants approached for screening, and 96% of those found to be eligible. Barriers to enrollment included delayed initiation of the trial relative to scheduled MESA study visits, a lower number of available MESA participants than expected, and a high prevalence (18%) of high-dose vitamin D supplementation (>1000 IU daily, an exclusion criterion). The final study visit was attended by 611 participants (92%), and median adherence was 98%. Our experience suggests that integration of a randomized trial into an existing observational cohort study may leverage strengths of the source population and enhance enrollment, retention, and adherence, although with limited enrollment capacity. The INVITe trial will use rigorously-collected data to advance understanding of individual determinants of vitamin D response. |
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The INdividual response to VITamin D (INVITe) trial was a randomized, placebo-controlled, parallel group trial of vitamin D3 supplementation (2000 IU daily) designed to determine clinical and genetic characteristics that modify the response to vitamin D supplementation. To enhance internal and external validity and reduce cost, the INVITe trial was nested within the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing prospective observational cohort study. The INVITe trial enrolled a community-based population of 666 racially and ethnically diverse participants from January 2017 to April 2019. This represents 30% of 2210 MESA participants approached for screening, and 96% of those found to be eligible. Barriers to enrollment included delayed initiation of the trial relative to scheduled MESA study visits, a lower number of available MESA participants than expected, and a high prevalence (18%) of high-dose vitamin D supplementation (>1000 IU daily, an exclusion criterion). The final study visit was attended by 611 participants (92%), and median adherence was 98%. Our experience suggests that integration of a randomized trial into an existing observational cohort study may leverage strengths of the source population and enhance enrollment, retention, and adherence, although with limited enrollment capacity. The INVITe trial will use rigorously-collected data to advance understanding of individual determinants of vitamin D response. |
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