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Ensayo controlado aleatorizado2010

The effect of different doses of vitamin D(3) on markers of vascular health in patients with type 2 diabetes: a randomised controlled trial

Witham MD, Dove FJ, Dryburgh M, Sugden JA, Morris AD, Struthers AD

Diabetologia · 191 citas

Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Marcadores de salud y funcionamiento

Quién lo pagó

Financiación
Financiación independiente
Universidad u hospital
University of Dundee
Organización sin fines de lucro
Heart Research UK
Organización sin fines de lucro
Diabetes UK
Organización sin fines de lucro
Chest Heart and Stroke Scotland
Subvenciones
Diabetes UK (06/0003429)

Según 4 financiadores declarados.

Publicación

Publicado
2010-07-01 · Diabetologia · vol. 53 · número 10 · págs. 2112–2119
Editorial
Springer Science+Business Media
Citado
269 citas · más que el 99% de estudios similares · 16.2× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
34 trabajos
Acceso
Lectura gratuita
Áreas de investigación
Vitamin D Research Studies · Diabetes, Cardiovascular Risks, and Lipoproteins · Nitric Oxide and Endothelin Effects
Palabras clave
vitamin D3 supplementation, type 2 diabetes, 25-hydroxyvitamin D, endothelial function, blood pressure, brain natriuretic peptide, insulin resistance, glycosylated haemoglobin, dose comparison, cardiovascular risk, endothelium-dependent vasodilation, endothelium-independent relaxation
MeSH
endothelium, vascular, humans, diabetes mellitus, type 2, insulin resistance, cholecalciferol, natriuretic peptide, brain, blood glucose, enzyme-linked immunosorbent assay, treatment outcome, double-blind method, blood pressure, dose-response relationship, drug, adolescent, adult, aged, aged, 80 and over, middle aged, female, male, glycated hemoglobin

6 autores

  • Miles D. Witham🇬🇧 · autor de correspondenciaNinewells Hospital
  • Fiona Dove🇬🇧Ninewells Hospital
  • Moira Dryburgh🇬🇧Ninewells Hospital
  • Jacqui Sugden🇬🇧Ninewells Hospital
  • Andrew D. Morris🇬🇧University of Dundee
  • Allan D. Struthers🇬🇧University of Dundee

Resumen

El texto original del estudio, en el idioma en que se publicó.

Aims/hypothesis

Low 25-hydroxyvitamin D levels predict future cardiovascular events and are common in patients with type 2 diabetes. We compared the effect of 100,000 and 200,000 IU doses of vitamin D(3) on endothelial function, blood pressure and markers of glycaemic control in patients with type 2 diabetes.

Methods

This was a randomised, parallel group, placebo-controlled trial. Patients with type 2 diabetes and baseline 25-hydroxyvitamin D levels <100 nmol/l were enrolled from community and hospital-based diabetes clinics. Participants were assessed in a university department of clinical pharmacology and received a single oral dose of placebo or vitamin D(3) (100,000 IU or 200,000 IU) at baseline, randomly allocated via numbered bottles prepared offsite; participants and investigators were both blinded to treatment allocation. Endothelial function, office blood pressure, B-type natriuretic peptide, insulin resistance and glycosylated haemoglobin were measured at baseline, and at 8 and 16 weeks.

Results

We randomised 61 participants to the three groups (placebo 22, 100,000 IU vitamin D(3) 19, 200,000 IU vitamin D(3) 20). There was no significant difference in the primary outcome of endothelial function at 8 weeks (placebo 5.2%, n = 22; 100,000 IU 4.3%, n = 19; 200,000 IU 4.9%, n = 17) or at 16 weeks. Insulin resistance and glycosylated haemoglobin did not improve with either dose of vitamin D(3). On covariate analysis, systolic blood pressure was significantly lower in both treatment arms than in the placebo group at 8 weeks (placebo 146.4 mmHg, 100,000 IU 141.4 mmHg [p = 0.04 vs placebo], 200,000 IU 136.8 mmHg [p = 0.03 vs placebo]). B-type natriuretic peptide levels were significantly lower in the 200,000 IU group by 16 weeks (placebo 34 pg/ml, 200,000 IU 21 pg/ml, p = 0.02). No significant excess of adverse effects was noted in the treatment arms.

Conclusions/interpretation

High-dose vitamin D(3) improved systolic blood pressure and B-type natriuretic peptide levels, but not endothelial function, insulin resistance or glycosylated haemoglobin in patients with type 2 diabetes.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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