Effect of Vitamin D and Omega-3 Fatty Acid Supplementation on Kidney Function in Patients With Type 2 Diabetes: A Randomized Clinical Trial
de Boer IH, Zelnick LR, Ruzinski J, Friedenberg G, Duszlak J, Bubes VY, Hoofnagle AN, Thadhani R, Glynn RJ, Buring JE, Sesso HD, Manson JE
JAMA · 98 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
- Gobierno
- National Cancer Institute
- Gobierno
- National Institute of Diabetes and Digestive and Kidney Diseases
- Gobierno
- NCI NIH HHS
- Gobierno
- NIDDK NIH HHS
- Subvenciones
- National Cancer Institute (U01CA138962); National Institute of Diabetes and Digestive and Kidney Diseases (R01DK088762); National Cancer Institute (R01CA138962); National Institute of Diabetes and Digestive and Kidney Diseases (P30DK017047)
Según 4 financiadores declarados.
Publicación
- Publicado
- 2019-11-08 · JAMA · vol. 322 · número 19 · pág. 1899
- Editorial
- American Medical Association
- Citado
- 123 citas · más que el 99% de estudios similares · 9.6× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 30 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Chronic Kidney Disease and Diabetes · Vitamin D Research Studies · Fatty Acid Research and Health
- Palabras clave
- vitamin D3 supplementation, omega-3 fatty acids, eicosapentaenoic acid, docosahexaenoic acid, chronic kidney disease, type 2 diabetes, renal function, glomerular filtration rate, cystatin C, estimated glomerular filtration rate decline, cardiovascular risk, VITAL trial, dietary supplementation, CKD prevention, end-stage renal disease, cardiovascular disease prevention
- MeSH
- kidney, humans, kidney calculi, diabetes mellitus, type 2, disease progression, gastrointestinal hemorrhage, cholecalciferol, fatty acids, omega-3, docosahexaenoic acids, eicosapentaenoic acid, vitamins, placebos, glomerular filtration rate, drug monitoring, drug therapy, combination, double-blind method, time factors, aged, middle aged, united states, female, male, renal insufficiency, chronic
12 autores
- Ian H. de Boer🇺🇸 · autor de correspondenciaUniversity of Washington; VA Puget Sound Health Care System
- Leila R. Zelnick🇺🇸University of Washington
- JOHN T. RUZINSKI🇺🇸University of Washington
- Georgina Friedenberg🇺🇸Brigham and Women's Hospital
- Julie Duszlak🇺🇸Brigham and Women's Hospital
- Vadim Y. Bubes🇺🇸Brigham and Women's Hospital
- Andrew N. Hoofnagle🇺🇸University of Washington
- Ravi Thadhani🇺🇸Cedars-Sinai Medical Center
- Robert J. Glynn🇺🇸Brigham and Women's Hospital; Harvard University
- Julie E. Buring🇺🇸Brigham and Women's Hospital; Harvard University
- Howard D. Sesso🇺🇸Brigham and Women's Hospital; Harvard University
- JoAnn E. Manson🇺🇸Brigham and Women's Hospital; Harvard University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Importance
Chronic kidney disease (CKD) is a common complication of type 2 diabetes that can lead to end-stage kidney disease and is associated with high cardiovascular risk. Few treatments are available to prevent CKD in type 2 diabetes.
Objective
To test whether supplementation with vitamin D3 or omega-3 fatty acids prevents development or progression of CKD in type 2 diabetes.
Design, setting, and participants
Randomized clinical trial with a 2 × 2 factorial design conducted among 1312 adults with type 2 diabetes recruited between November 2011 and March 2014 from all 50 US states as an ancillary study to the Vitamin D and Omega-3 Trial (VITAL), coordinated by a single center in Massachusetts. Follow-up was completed in December 2017.
Interventions
Participants were randomized to receive vitamin D3 (2000 IU/d) and omega-3 fatty acids (eicosapentaenoic acid and docosahexaenoic acid; 1 g/d) (n = 370), vitamin D3 and placebo (n = 333), placebo and omega-3 fatty acids (n = 289), or 2 placebos (n = 320) for 5 years.
Main outcomes and measures
The primary outcome was change in glomerular filtration rate estimated from serum creatinine and cystatin C (eGFR) from baseline to year 5.
Results
Among 1312 participants randomized (mean age, 67.6 years; 46% women; 31% of racial or ethnic minority), 934 (71%) completed the study. Baseline mean eGFR was 85.8 (SD, 22.1) mL/min/1.73 m2. Mean change in eGFR from baseline to year 5 was -12.3 (95% CI, -13.4 to -11.2) mL/min/1.73 m2 with vitamin D3 vs -13.1 (95% CI, -14.2 to -11.9) mL/min/1.73 m2 with placebo (difference, 0.9 [95% CI, -0.7 to 2.5] mL/min/1.73 m2). Mean change in eGFR was -12.2 (95% CI, -13.3 to -11.1) mL/min/1.73 m2 with omega-3 fatty acids vs -13.1 (95% CI, -14.2 to -12.0) mL/min/1.73 m2 with placebo (difference, 0.9 [95% CI, -0.7 to 2.6] mL/min/1.73 m2). There was no significant interaction between the 2 interventions. Kidney stones occurred among 58 participants (n = 32 receiving vitamin D3 and n = 26 receiving placebo) and gastrointestinal bleeding among 45 (n = 28 receiving omega-3 fatty acids and n = 17 receiving placebo).
Conclusions and relevance
Among adults with type 2 diabetes, supplementation with vitamin D3 or omega-3 fatty acids, compared with placebo, resulted in no significant difference in change in eGFR at 5 years. The findings do not support the use of vitamin D or omega-3 fatty acid supplementation for preserving kidney function in patients with type 2 diabetes.
Trial registration
ClinicalTrials.gov Identifier: NCT01684722.
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