No effects of oral vitamin D supplementation on non-alcoholic fatty liver disease in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial
Barchetta I, Del Ben M, Angelico F, Di Martino M, Fraioli A, La Torre G, Saulle R, Perri L, Morini S, Tiberti C, Bertoccini L, Cimini FA, Panimolle F, Catalano C, Baroni MG, Cavallo MG
BMC medicine · 132 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
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- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
Según la declaración de financiación del texto completo.
Publicación
- Publicado
- 2016-06-15 · BMC Med · vol. 14 · número 1 · pág. 92
- Editorial
- BioMed Central
- Citado
- 180 citas · más que el 99% de estudios similares · 16.1× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 46 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Liver Disease Diagnosis and Treatment · Vitamin D Research Studies · Hepatocellular Carcinoma Treatment and Prognosis
- Palabras clave
- non-alcoholic fatty liver disease, type 2 diabetes, vitamin D supplementation, vitamin D3, hepatic steatosis, hepatic fat fraction, 25-hydroxyvitamin D, cardiovascular risk, insulin resistance, adiponectin, liver fibrosis markers, fatty liver index
- MeSH
- humans, diabetes mellitus, type 2, cholecalciferol, administration, oral, risk factors, double-blind method, dietary supplements, middle aged, italy, female, male, non-alcoholic fatty liver disease
16 autores
- Ilaria Barchetta🇮🇹Sapienza University of Rome
- Maria Del Ben🇮🇹Sapienza University of Rome
- Francesco Angelico🇮🇹Sapienza University of Rome
- Michele Di Martino🇮🇹Sapienza University of Rome
- A Fraioli🇮🇹Sapienza University of Rome
- Giuseppe La Torre🇮🇹Sapienza University of Rome
- Rosella Saulle🇮🇹Sapienza University of Rome
- Ludovica Perri🇮🇹Sapienza University of Rome
- Sergio Morini🇮🇹Università Campus Bio-Medico
- Claudio Tiberti🇮🇹Sapienza University of Rome
- Laura Bertoccini🇮🇹Sapienza University of Rome
- Flavia Agata Cimini🇮🇹Sapienza University of Rome
- Francesca Panimolle🇮🇹Sapienza University of Rome
- Carlo Catalano🇮🇹Sapienza University of Rome
- Marco Giorgio Baroni🇮🇹University of Cagliari; Sapienza University of Rome
- Maria Gisella Cavallo🇮🇹 · autor de correspondenciaSapienza University of Rome
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Non-alcoholic fatty liver disease (NAFLD) is the most common hepatic disorder worldwide, reaching prevalence up to 90 % in obese patients with type 2 diabetes (T2D), and representing an independent risk factor for cardiovascular mortality. Furthermore, the coexistence of T2D and NAFLD leads to higher incidence of diabetes' complications and additive detrimental liver outcomes. The existence of a close association between NAFLD and hypovitaminosis D, along with the anti-inflammatory and insulin-sensitizing properties of vitamin D, have been largely described, but vitamin D effects on hepatic fat content have never been tested in a randomized controlled trial. We assessed the efficacy and safety of 24-week oral high-dose vitamin D supplementation in T2D patients with NAFLD.
Methods
This randomized, double-blind, placebo-controlled trial was carried out at the Diabetes Centre of Sapienza University, Rome, Italy, to assess oral treatment with cholecalciferol (2000 IU/day) or placebo in T2D patients with NAFLD. The primary endpoint was reduction of hepatic fat fraction (HFF) measured by magnetic resonance; as hepatic outcomes, we also investigated changes in serum transaminases, CK18-M30, N-terminal Procollagen III Propeptide (P3NP) levels, and Fatty Liver Index (FLI). Secondary endpoints were improvement in metabolic (fasting glycaemia, HbA1c, lipids, HOMA-IR, HOMA-β, ADIPO-IR, body fat distribution) and cardiovascular (ankle-brachial index, intima-media thickness, flow-mediated dilatation) parameters from baseline to end of treatment.
Results
Sixty-five patients were randomized, 26 (cholecalciferol) and 29 (placebo) subjects completed the study. 25(OH) vitamin D significantly increased in the active treated group (48.15 ± 23.7 to 89.80 ± 23.6 nmol/L, P < 0.001); however, no group differences were found in HFF, transaminases, CK18-M30, P3NP levels or FLI after 24 weeks. Vitamin D neither changed the metabolic profile nor the cardiovascular parameters.
Conclusions
Oral high-dose vitamin D supplementation over 24 weeks did not improve hepatic steatosis or metabolic/cardiovascular parameters in T2D patients with NAFLD. Studies with a longer intervention period are warranted for exploring the effect of long time exposure to vitamin D.
Trial registration
This trial was approved on July 2011 by the Ethics Committee of Policlinico Umberto I, Sapienza University of Rome, Italy, and registered at www.clinicaltrialsregister.eu number 2011-003010-17.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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