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Vitamin D supplementation and adverse skeletal and non-skeletal outcomes in individuals at increased cardiovascular risk: Results from the International Polycap Study (TIPS)-3 randomized controlled trial.
Joseph, P; Pais, P; Gao, P; Teo, K; Xavier, D; Lopez-Jaramillo, P; Yusoff, K; Santoso, A; Gamra, H; Talukder, S H; Christou, C; Dagenais, G; Tyrwhitt, J; Bosch, J; Dans, A; Yusuf, S.
Afiliación
  • Joseph P; Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada. Electronic address: philip.joseph@phri.ca.
  • Pais P; St. John's Medical College, Bangalore, India.
  • Gao P; Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.
  • Teo K; Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.
  • Xavier D; St. John's Medical College, Bangalore, India.
  • Lopez-Jaramillo P; Masira Research Institute Medical School, Universidad de Santander, Bucaramanga, Colombia.
  • Yusoff K; UiTM Selayang, Selangor and UCSI University, Cheras, Kuala Lumpur, Malaysia.
  • Santoso A; Universitas Indonesia, National Cardiovascular Centre, Jakarta, Indonesia.
  • Gamra H; Fattouma Bourguiba University Hospital and University of Monastir, Tunisia.
  • Talukder SH; Eminence, Dhaka, Bangladesh.
  • Christou C; Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.
  • Dagenais G; Université Laval Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, Canada.
  • Tyrwhitt J; Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.
  • Bosch J; Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.
  • Dans A; University of the Philippines, Manila, Philippines.
  • Yusuf S; Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.
Nutr Metab Cardiovasc Dis ; 33(2): 434-440, 2023 02.
Article en En | MEDLINE | ID: mdl-36604262
BACKGROUND AND AIMS: Vitamin D has mostly been tested in Western populations. We examined the effect of high dose vitamin D in a population drawn predominantly from outside of Western countries. METHODS AND RESULTS: This randomized trial tested vitamin D 60,000 IU monthly in 5670 participants without vascular disease but at increased CV risk. The primary outcome was fracture. The secondary outcome was the composite of CV death, myocardial infarction stroke, cancer, fracture or fall. Death was a pre-specified outcome. Mean age was 63.9 years, and 3005 (53.0%) were female. 3034 (53.5%) participants resided in South Asia, 1904 (33.6%) in South East Asia, 480 (8.5%) in South America, and 252 (4.4%) in other regions. Mean follow-up was 4.6 years. A fracture occurred in 20 participants (0.2 per 100 person years) assigned to vitamin D, and 19 (0.1 per 100 person years) assigned to placebo (HR 1.06, 95% CI 0.57-1.99, p-value = 0.86). The secondary outcome occurred in 222 participants (1.8 per 100 person years) assigned to vitamin D, and 198 (1.6 per 100 person years) assigned to placebo (HR 1.13, 95% CI 0.93-1.37, p = 0.22). 172 (1.3 per 100 person years) participants assigned to vitamin D died, compared with 135 (1.0 per 100 person years) assigned to placebo (HR 1.29, 95% CI 1.03-1.61, p = 0.03). CONCLUSION: In a population predominantly from South Asia, South East Asia and South America, high-dose vitamin D did not reduce adverse skeletal or non-skeletal outcomes. Higher mortality was observed in the vitamin D group. REGISTRATION NUMBER: NCT01646437.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedades Cardiovasculares / Fracturas Óseas Tipo de estudio: Clinical_trials / Diagnostic_studies / Etiology_studies / Risk_factors_studies Límite: Female / Humans / Male / Middle aged Idioma: En Revista: Nutr Metab Cardiovasc Dis Asunto de la revista: ANGIOLOGIA / CARDIOLOGIA / CIENCIAS DA NUTRICAO / METABOLISMO Año: 2023 Tipo del documento: Article Pais de publicación: Países Bajos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedades Cardiovasculares / Fracturas Óseas Tipo de estudio: Clinical_trials / Diagnostic_studies / Etiology_studies / Risk_factors_studies Límite: Female / Humans / Male / Middle aged Idioma: En Revista: Nutr Metab Cardiovasc Dis Asunto de la revista: ANGIOLOGIA / CARDIOLOGIA / CIENCIAS DA NUTRICAO / METABOLISMO Año: 2023 Tipo del documento: Article Pais de publicación: Países Bajos