Vitamin D supplementation vs. placebo and incident type 2 diabetes in an ancillary study of the randomized Vitamin D and Omega-3 Trial

Observational and experimental evidence suggests that vitamin D plays a role in type 2 diabetes (T2D). However, prior randomized supplementation trials are limited to high-risk patients with prediabetes. Here we aim to evaluate whether vitamin D supplementation reduces risk of T2D in a general popul...

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Veröffentlicht in:Nature communications Jg. 16; H. 1; S. 3332 - 8
Hauptverfasser: Tobias, Deirdre K., Pradhan, Aruna D., Duran, Edward K., Li, Chunying, Song, Yiqing, Buring, Julie E., Cook, Nancy R., Mora, Samia, Manson, JoAnn E.
Format: Journal Article
Sprache:Englisch
Veröffentlicht: London Nature Publishing Group UK 08.04.2025
Nature Publishing Group
Nature Portfolio
Schlagworte:
25-Hydroxyvitamin D
692/163/2743/137/773
692/499
Adults
Age
Aged
Body mass index
Body size
Calciferol
Cardiovascular diseases
Cholecalciferol - administration & dosage
Cholecalciferol - therapeutic use
Clinical trials
Diabetes
Diabetes mellitus (non-insulin dependent)
Diabetes Mellitus, Type 2 - epidemiology
Diabetes Mellitus, Type 2 - prevention & control
Dietary Supplements
Double-Blind Method
Fatty Acids, Omega-3 - administration & dosage
Fatty Acids, Omega-3 - therapeutic use
Female
Humanities and Social Sciences
Humans
Incidence
Male
Meta-analysis
Middle Aged
multidisciplinary
Placebos
Prevention
Risk groups
Science
Science (multidisciplinary)
Systematic review
Vitamin D
Vitamin D - administration & dosage
Vitamin D3
United States > US
ISSN:2041-1723, 2041-1723
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Abstract Observational and experimental evidence suggests that vitamin D plays a role in type 2 diabetes (T2D). However, prior randomized supplementation trials are limited to high-risk patients with prediabetes. Here we aim to evaluate whether vitamin D supplementation reduces risk of T2D in a general population of older US adults. The study design is an ancillary analysis (VITAL-T2D) of The Vitamin D and Omega-3 Trial (VITAL), a completed randomized, double-blind, placebo-controlled 2 × 2 trial of daily vitamin D 3 (cholecalciferol; 2000 IU/day) and omega-3 fatty acids (1 g/day) for the primary prevention of cancer and cardiovascular disease. We also conducted a systematic review and meta-analysis of vitamin D trial (≥1000 IU/d cholecalciferol) vs. placebo and T2D risk. We analyzed 22,220 adults with mean age 67.2 years (SD = 7.1) without T2D at enrollment (2011 to 2014), randomized to vitamin D 3 or placebo. Mean body mass index (BMI) was 27.5 kg/m 2 (SD = 5.3), with 51% female and 17% Black race/ethnicity. A subcohort ( n  = 911) attended in-person visits at baseline and 2 years for glycemic trait analyses. Our meta-analysis included 3 additional trials (5205 participants; 936 T2D cases). The primary outcome for the VITAL-T2D is intention-to-treat effect of vitamin D vs. placebo for incident T2D. T2D incidence (cases/1000py) at median follow-up of 5.3 y was 3.98 for vitamin D and 4.37 for placebo (hazard ratio [HR] = 0.91; 95% confidence interval [CI] = 0.76, 1.09). Results did not differ by age, sex, BMI, or baseline 25-hydroxyvitamin D, and vitamin D had no effect on glycemic traits at 2 years. Meta-analysis of 4 trials ( n  = 5205; 936 T2D cases) obtained HR = 0.89 (CI = 0.80, 0.99). In conclusion, Vitamin D supplementation did not reduce T2D in older US adults, but a modest reduction was observed when meta-analyzed with prior trials. Trial Registration : ClinicalTrials.gov #NCT01633177. Systematic Review Registration : PROSPERO #CRD42019147562. Observational and experimental evidence suggests that vitamin D plays a role in glycemic control. Here, the authors report that in an ancillary study of the placebo-controlled randomized VITAL trial there is no effect of 2000 IU/day of vitamin D supplementation over 5 years on the prevention of type 2 diabetes in 22,220 older US adults.
AbstractList Observational and experimental evidence suggests that vitamin D plays a role in type 2 diabetes (T2D). However, prior randomized supplementation trials are limited to high-risk patients with prediabetes. Here we aim to evaluate whether vitamin D supplementation reduces risk of T2D in a general population of older US adults. The study design is an ancillary analysis (VITAL-T2D) of The Vitamin D and Omega-3 Trial (VITAL), a completed randomized, double-blind, placebo-controlled 2 × 2 trial of daily vitamin D3 (cholecalciferol; 2000 IU/day) and omega-3 fatty acids (1 g/day) for the primary prevention of cancer and cardiovascular disease. We also conducted a systematic review and meta-analysis of vitamin D trial (≥1000 IU/d cholecalciferol) vs. placebo and T2D risk. We analyzed 22,220 adults with mean age 67.2 years (SD = 7.1) without T2D at enrollment (2011 to 2014), randomized to vitamin D3 or placebo. Mean body mass index (BMI) was 27.5 kg/m2 (SD = 5.3), with 51% female and 17% Black race/ethnicity. A subcohort (n = 911) attended in-person visits at baseline and 2 years for glycemic trait analyses. Our meta-analysis included 3 additional trials (5205 participants; 936 T2D cases). The primary outcome for the VITAL-T2D is intention-to-treat effect of vitamin D vs. placebo for incident T2D. T2D incidence (cases/1000py) at median follow-up of 5.3 y was 3.98 for vitamin D and 4.37 for placebo (hazard ratio [HR] = 0.91; 95% confidence interval [CI] = 0.76, 1.09). Results did not differ by age, sex, BMI, or baseline 25-hydroxyvitamin D, and vitamin D had no effect on glycemic traits at 2 years. Meta-analysis of 4 trials (n = 5205; 936 T2D cases) obtained HR = 0.89 (CI = 0.80, 0.99). In conclusion, Vitamin D supplementation did not reduce T2D in older US adults, but a modest reduction was observed when meta-analyzed with prior trials. Trial Registration: ClinicalTrials.gov #NCT01633177. Systematic Review Registration: PROSPERO #CRD42019147562.Observational and experimental evidence suggests that vitamin D plays a role in type 2 diabetes (T2D). However, prior randomized supplementation trials are limited to high-risk patients with prediabetes. Here we aim to evaluate whether vitamin D supplementation reduces risk of T2D in a general population of older US adults. The study design is an ancillary analysis (VITAL-T2D) of The Vitamin D and Omega-3 Trial (VITAL), a completed randomized, double-blind, placebo-controlled 2 × 2 trial of daily vitamin D3 (cholecalciferol; 2000 IU/day) and omega-3 fatty acids (1 g/day) for the primary prevention of cancer and cardiovascular disease. We also conducted a systematic review and meta-analysis of vitamin D trial (≥1000 IU/d cholecalciferol) vs. placebo and T2D risk. We analyzed 22,220 adults with mean age 67.2 years (SD = 7.1) without T2D at enrollment (2011 to 2014), randomized to vitamin D3 or placebo. Mean body mass index (BMI) was 27.5 kg/m2 (SD = 5.3), with 51% female and 17% Black race/ethnicity. A subcohort (n = 911) attended in-person visits at baseline and 2 years for glycemic trait analyses. Our meta-analysis included 3 additional trials (5205 participants; 936 T2D cases). The primary outcome for the VITAL-T2D is intention-to-treat effect of vitamin D vs. placebo for incident T2D. T2D incidence (cases/1000py) at median follow-up of 5.3 y was 3.98 for vitamin D and 4.37 for placebo (hazard ratio [HR] = 0.91; 95% confidence interval [CI] = 0.76, 1.09). Results did not differ by age, sex, BMI, or baseline 25-hydroxyvitamin D, and vitamin D had no effect on glycemic traits at 2 years. Meta-analysis of 4 trials (n = 5205; 936 T2D cases) obtained HR = 0.89 (CI = 0.80, 0.99). In conclusion, Vitamin D supplementation did not reduce T2D in older US adults, but a modest reduction was observed when meta-analyzed with prior trials. Trial Registration: ClinicalTrials.gov #NCT01633177. Systematic Review Registration: PROSPERO #CRD42019147562.
Observational and experimental evidence suggests that vitamin D plays a role in type 2 diabetes (T2D). However, prior randomized supplementation trials are limited to high-risk patients with prediabetes. Here we aim to evaluate whether vitamin D supplementation reduces risk of T2D in a general population of older US adults. The study design is an ancillary analysis (VITAL-T2D) of The Vitamin D and Omega-3 Trial (VITAL), a completed randomized, double-blind, placebo-controlled 2 × 2 trial of daily vitamin D3 (cholecalciferol; 2000 IU/day) and omega-3 fatty acids (1 g/day) for the primary prevention of cancer and cardiovascular disease. We also conducted a systematic review and meta-analysis of vitamin D trial (≥1000 IU/d cholecalciferol) vs. placebo and T2D risk. We analyzed 22,220 adults with mean age 67.2 years (SD = 7.1) without T2D at enrollment (2011 to 2014), randomized to vitamin D3 or placebo. Mean body mass index (BMI) was 27.5 kg/m2 (SD = 5.3), with 51% female and 17% Black race/ethnicity. A subcohort (n = 911) attended in-person visits at baseline and 2 years for glycemic trait analyses. Our meta-analysis included 3 additional trials (5205 participants; 936 T2D cases). The primary outcome for the VITAL-T2D is intention-to-treat effect of vitamin D vs. placebo for incident T2D. T2D incidence (cases/1000py) at median follow-up of 5.3 y was 3.98 for vitamin D and 4.37 for placebo (hazard ratio [HR] = 0.91; 95% confidence interval [CI] = 0.76, 1.09). Results did not differ by age, sex, BMI, or baseline 25-hydroxyvitamin D, and vitamin D had no effect on glycemic traits at 2 years. Meta-analysis of 4 trials (n = 5205; 936 T2D cases) obtained HR = 0.89 (CI = 0.80, 0.99). In conclusion, Vitamin D supplementation did not reduce T2D in older US adults, but a modest reduction was observed when meta-analyzed with prior trials. Trial Registration: ClinicalTrials.gov #NCT01633177. Systematic Review Registration: PROSPERO #CRD42019147562. Observational and experimental evidence suggests that vitamin D plays a role in glycemic control. Here, the authors report that in an ancillary study of the placebo-controlled randomized VITAL trial there is no effect of 2000 IU/day of vitamin D supplementation over 5 years on the prevention of type 2 diabetes in 22,220 older US adults.
Observational and experimental evidence suggests that vitamin D plays a role in type 2 diabetes (T2D). However, prior randomized supplementation trials are limited to high-risk patients with prediabetes. Here we aim to evaluate whether vitamin D supplementation reduces risk of T2D in a general population of older US adults. The study design is an ancillary analysis (VITAL-T2D) of The Vitamin D and Omega-3 Trial (VITAL), a completed randomized, double-blind, placebo-controlled 2 × 2 trial of daily vitamin D 3 (cholecalciferol; 2000 IU/day) and omega-3 fatty acids (1 g/day) for the primary prevention of cancer and cardiovascular disease. We also conducted a systematic review and meta-analysis of vitamin D trial (≥1000 IU/d cholecalciferol) vs. placebo and T2D risk. We analyzed 22,220 adults with mean age 67.2 years (SD = 7.1) without T2D at enrollment (2011 to 2014), randomized to vitamin D 3 or placebo. Mean body mass index (BMI) was 27.5 kg/m 2 (SD = 5.3), with 51% female and 17% Black race/ethnicity. A subcohort ( n  = 911) attended in-person visits at baseline and 2 years for glycemic trait analyses. Our meta-analysis included 3 additional trials (5205 participants; 936 T2D cases). The primary outcome for the VITAL-T2D is intention-to-treat effect of vitamin D vs. placebo for incident T2D. T2D incidence (cases/1000py) at median follow-up of 5.3 y was 3.98 for vitamin D and 4.37 for placebo (hazard ratio [HR] = 0.91; 95% confidence interval [CI] = 0.76, 1.09). Results did not differ by age, sex, BMI, or baseline 25-hydroxyvitamin D, and vitamin D had no effect on glycemic traits at 2 years. Meta-analysis of 4 trials ( n  = 5205; 936 T2D cases) obtained HR = 0.89 (CI = 0.80, 0.99). In conclusion, Vitamin D supplementation did not reduce T2D in older US adults, but a modest reduction was observed when meta-analyzed with prior trials. Trial Registration : ClinicalTrials.gov #NCT01633177. Systematic Review Registration : PROSPERO #CRD42019147562. Observational and experimental evidence suggests that vitamin D plays a role in glycemic control. Here, the authors report that in an ancillary study of the placebo-controlled randomized VITAL trial there is no effect of 2000 IU/day of vitamin D supplementation over 5 years on the prevention of type 2 diabetes in 22,220 older US adults.
Abstract Observational and experimental evidence suggests that vitamin D plays a role in type 2 diabetes (T2D). However, prior randomized supplementation trials are limited to high-risk patients with prediabetes. Here we aim to evaluate whether vitamin D supplementation reduces risk of T2D in a general population of older US adults. The study design is an ancillary analysis (VITAL-T2D) of The Vitamin D and Omega-3 Trial (VITAL), a completed randomized, double-blind, placebo-controlled 2 × 2 trial of daily vitamin D 3 (cholecalciferol; 2000 IU/day) and omega-3 fatty acids (1 g/day) for the primary prevention of cancer and cardiovascular disease. We also conducted a systematic review and meta-analysis of vitamin D trial (≥1000 IU/d cholecalciferol) vs. placebo and T2D risk. We analyzed 22,220 adults with mean age 67.2 years (SD = 7.1) without T2D at enrollment (2011 to 2014), randomized to vitamin D 3 or placebo. Mean body mass index (BMI) was 27.5 kg/m2 (SD = 5.3), with 51% female and 17% Black race/ethnicity. A subcohort (n = 911) attended in-person visits at baseline and 2 years for glycemic trait analyses. Our meta-analysis included 3 additional trials (5205 participants; 936 T2D cases). The primary outcome for the VITAL-T2D is intention-to-treat effect of vitamin D vs. placebo for incident T2D. T2D incidence (cases/1000py) at median follow-up of 5.3 y was 3.98 for vitamin D and 4.37 for placebo (hazard ratio [HR] = 0.91; 95% confidence interval [CI] = 0.76, 1.09). Results did not differ by age, sex, BMI, or baseline 25-hydroxyvitamin D, and vitamin D had no effect on glycemic traits at 2 years. Meta-analysis of 4 trials (n = 5205; 936 T2D cases) obtained HR = 0.89 (CI = 0.80, 0.99). In conclusion, Vitamin D supplementation did not reduce T2D in older US adults, but a modest reduction was observed when meta-analyzed with prior trials. Trial Registration: ClinicalTrials.gov #NCT01633177. Systematic Review Registration: PROSPERO #CRD42019147562.
Observational and experimental evidence suggests that vitamin D plays a role in type 2 diabetes (T2D). However, prior randomized supplementation trials are limited to high-risk patients with prediabetes. Here we aim to evaluate whether vitamin D supplementation reduces risk of T2D in a general population of older US adults. The study design is an ancillary analysis (VITAL-T2D) of The Vitamin D and Omega-3 Trial (VITAL), a completed randomized, double-blind, placebo-controlled 2 × 2 trial of daily vitamin D (cholecalciferol; 2000 IU/day) and omega-3 fatty acids (1 g/day) for the primary prevention of cancer and cardiovascular disease. We also conducted a systematic review and meta-analysis of vitamin D trial (≥1000 IU/d cholecalciferol) vs. placebo and T2D risk. We analyzed 22,220 adults with mean age 67.2 years (SD = 7.1) without T2D at enrollment (2011 to 2014), randomized to vitamin D or placebo. Mean body mass index (BMI) was 27.5 kg/m (SD = 5.3), with 51% female and 17% Black race/ethnicity. A subcohort (n = 911) attended in-person visits at baseline and 2 years for glycemic trait analyses. Our meta-analysis included 3 additional trials (5205 participants; 936 T2D cases). The primary outcome for the VITAL-T2D is intention-to-treat effect of vitamin D vs. placebo for incident T2D. T2D incidence (cases/1000py) at median follow-up of 5.3 y was 3.98 for vitamin D and 4.37 for placebo (hazard ratio [HR] = 0.91; 95% confidence interval [CI] = 0.76, 1.09). Results did not differ by age, sex, BMI, or baseline 25-hydroxyvitamin D, and vitamin D had no effect on glycemic traits at 2 years. Meta-analysis of 4 trials (n = 5205; 936 T2D cases) obtained HR = 0.89 (CI = 0.80, 0.99). In conclusion, Vitamin D supplementation did not reduce T2D in older US adults, but a modest reduction was observed when meta-analyzed with prior trials. Trial Registration: ClinicalTrials.gov #NCT01633177. Systematic Review Registration: PROSPERO #CRD42019147562.
Observational and experimental evidence suggests that vitamin D plays a role in type 2 diabetes (T2D). However, prior randomized supplementation trials are limited to high-risk patients with prediabetes. Here we aim to evaluate whether vitamin D supplementation reduces risk of T2D in a general population of older US adults. The study design is an ancillary analysis (VITAL-T2D) of The Vitamin D and Omega-3 Trial (VITAL), a completed randomized, double-blind, placebo-controlled 2 × 2 trial of daily vitamin D3 (cholecalciferol; 2000 IU/day) and omega-3 fatty acids (1 g/day) for the primary prevention of cancer and cardiovascular disease. We also conducted a systematic review and meta-analysis of vitamin D trial (≥1000 IU/d cholecalciferol) vs. placebo and T2D risk. We analyzed 22,220 adults with mean age 67.2 years (SD = 7.1) without T2D at enrollment (2011 to 2014), randomized to vitamin D3 or placebo. Mean body mass index (BMI) was 27.5 kg/m2 (SD = 5.3), with 51% female and 17% Black race/ethnicity. A subcohort (n = 911) attended in-person visits at baseline and 2 years for glycemic trait analyses. Our meta-analysis included 3 additional trials (5205 participants; 936 T2D cases). The primary outcome for the VITAL-T2D is intention-to-treat effect of vitamin D vs. placebo for incident T2D. T2D incidence (cases/1000py) at median follow-up of 5.3 y was 3.98 for vitamin D and 4.37 for placebo (hazard ratio [HR] = 0.91; 95% confidence interval [CI] = 0.76, 1.09). Results did not differ by age, sex, BMI, or baseline 25-hydroxyvitamin D, and vitamin D had no effect on glycemic traits at 2 years. Meta-analysis of 4 trials (n = 5205; 936 T2D cases) obtained HR = 0.89 (CI = 0.80, 0.99). In conclusion, Vitamin D supplementation did not reduce T2D in older US adults, but a modest reduction was observed when meta-analyzed with prior trials. Trial Registration: ClinicalTrials.gov #NCT01633177. Systematic Review Registration: PROSPERO #CRD42019147562.Observational and experimental evidence suggests that vitamin D plays a role in glycemic control. Here, the authors report that in an ancillary study of the placebo-controlled randomized VITAL trial there is no effect of 2000 IU/day of vitamin D supplementation over 5 years on the prevention of type 2 diabetes in 22,220 older US adults.
ArticleNumber 3332
Author Tobias, Deirdre K.
Manson, JoAnn E.
Li, Chunying
Pradhan, Aruna D.
Cook, Nancy R.
Song, Yiqing
Mora, Samia
Duran, Edward K.
Buring, Julie E.
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  surname: Tobias
  fullname: Tobias, Deirdre K.
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  organization: Division of Preventive Medicine, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Department of Nutrition, Harvard TH Chan School of Public Health
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  givenname: Aruna D.
  surname: Pradhan
  fullname: Pradhan, Aruna D.
  organization: Division of Preventive Medicine, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School
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  givenname: Edward K.
  surname: Duran
  fullname: Duran, Edward K.
  organization: Division of Cardiovascular Medicine, University of California
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  givenname: Chunying
  surname: Li
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  organization: Division of Preventive Medicine, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School
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  organization: Division of Preventive Medicine, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School
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  givenname: Julie E.
  surname: Buring
  fullname: Buring, Julie E.
  organization: Division of Preventive Medicine, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Department of Epidemiology, Harvard TH Chan School of Public Health
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  givenname: Nancy R.
  orcidid: 0000-0002-9705-0842
  surname: Cook
  fullname: Cook, Nancy R.
  organization: Division of Preventive Medicine, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Department of Biostatistics, Harvard TH Chan School of Public Health
– sequence: 8
  givenname: Samia
  orcidid: 0000-0001-6283-0980
  surname: Mora
  fullname: Mora, Samia
  organization: Division of Preventive Medicine, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School
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  organization: Division of Preventive Medicine, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Department of Epidemiology, Harvard TH Chan School of Public Health
BackLink https://www.ncbi.nlm.nih.gov/pubmed/40199888$$D View this record in MEDLINE/PubMed
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CitedBy_id crossref_primary_10_2147_COPD_S520795
crossref_primary_10_7759_cureus_90776
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AG Pittas (58721_CR8) 2023; 176
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Snippet Observational and experimental evidence suggests that vitamin D plays a role in type 2 diabetes (T2D). However, prior randomized supplementation trials are...
Abstract Observational and experimental evidence suggests that vitamin D plays a role in type 2 diabetes (T2D). However, prior randomized supplementation...
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SubjectTerms 25-Hydroxyvitamin D
692/163/2743/137/773
692/499
Adults
Age
Aged
Body mass index
Body size
Calciferol
Cardiovascular diseases
Cholecalciferol - administration & dosage
Cholecalciferol - therapeutic use
Clinical trials
Diabetes
Diabetes mellitus (non-insulin dependent)
Diabetes Mellitus, Type 2 - epidemiology
Diabetes Mellitus, Type 2 - prevention & control
Dietary Supplements
Double-Blind Method
Fatty Acids, Omega-3 - administration & dosage
Fatty Acids, Omega-3 - therapeutic use
Female
Humanities and Social Sciences
Humans
Incidence
Male
Meta-analysis
Middle Aged
multidisciplinary
Placebos
Prevention
Risk groups
Science
Science (multidisciplinary)
Systematic review
Vitamin D
Vitamin D - administration & dosage
Vitamin D3
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Title Vitamin D supplementation vs. placebo and incident type 2 diabetes in an ancillary study of the randomized Vitamin D and Omega-3 Trial
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