Effect of vitamin D supplementation on progression of knee pain and cartilage volume loss in patients with symptomatic osteoarthritis: a randomized controlled trial
McAlindon T, LaValley M, Schneider E, Nuite M, Lee JY, Price LL, Lo G, Dawson-Hughes B
JAMA · 196 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
- Brigham and Women's Hospital
- Gobierno
- National Institutes of Health
- Gobierno
- National Institute of Arthritis and Musculoskeletal and Skin Diseases
- Gobierno
- National Center for Research Resources
- Gobierno
- NIAMS NIH HHS
- Gobierno
- NCRR NIH HHS
- Subvenciones
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01 AR51361); National Center for Research Resources (UL1RR025752); National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01-AR-051361)
Según 6 financiadores declarados.
Publicación
- Publicado
- 2013-01-09 · JAMA · vol. 309 · número 2 · pág. 155
- Editorial
- American Medical Association
- Citado
- 261 citas · más que el 100% de estudios similares · 22.8× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 43 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY
- Áreas de investigación
- Osteoarthritis Treatment and Mechanisms · Vitamin D Research Studies · Musculoskeletal pain and rehabilitation
- Palabras clave
- knee osteoarthritis, vitamin D supplementation, vitamin D3, cartilage volume loss, knee pain, structural progression, serum 25-hydroxyvitamin D, WOMAC, cartilage thickness, bone marrow lesions, joint space narrowing, physical function, dose escalation, placebo effect, radiographic progression
- MeSH
- cartilage, knee joint, humans, osteoarthritis, knee, pain, disease progression, vitamins, vitamin d, magnetic resonance imaging, treatment outcome, double-blind method, dietary supplements, aged, middle aged, female, male
8 autores
- Timothy E. McAlindon🇺🇸 · autor de correspondenciaTufts Medical Center
- Michael P. LaValley🇺🇸Boston University; Tufts University; Tufts Medical Center; Michael E. DeBakey VA Medical Center; Cleveland Clinic; Baylor College of Medicine; Health Services Research & Development; Jean Mayer Human Nutrition Research Center on Aging
- Erica Schneider🇺🇸Boston University; Tufts University; Tufts Medical Center; Michael E. DeBakey VA Medical Center; Cleveland Clinic; Baylor College of Medicine; Health Services Research & Development; Jean Mayer Human Nutrition Research Center on Aging
- Melynn Nuite
- Ji Yeon Lee🇺🇸Boston University; Tufts University; Tufts Medical Center; Michael E. DeBakey VA Medical Center; Cleveland Clinic; Baylor College of Medicine; Health Services Research & Development; Jean Mayer Human Nutrition Research Center on Aging
- Lori Lyn Price🇺🇸Boston University; Tufts University; Tufts Medical Center; Michael E. DeBakey VA Medical Center; Cleveland Clinic; Baylor College of Medicine; Health Services Research & Development; Jean Mayer Human Nutrition Research Center on Aging
- Grace H. Lo🇺🇸Boston University; Tufts University; Tufts Medical Center; Michael E. DeBakey VA Medical Center; Cleveland Clinic; Baylor College of Medicine; Health Services Research & Development; Jean Mayer Human Nutrition Research Center on Aging
- Bess Dawson‐Hughes🇺🇸Boston University; Tufts University; Tufts Medical Center; Michael E. DeBakey VA Medical Center; Cleveland Clinic; Baylor College of Medicine; Health Services Research & Development; Jean Mayer Human Nutrition Research Center on Aging
Resumen
El texto original del estudio, en el idioma en que se publicó.
Importance
Knee osteoarthritis (OA), a disorder of cartilage and periarticular bone, is a public health problem without effective medical treatments. Some studies have suggested that vitamin D may protect against structural progression.
Objective
To determine whether vitamin D supplementation reduces symptom and structural progression of knee OA.
Design, setting, and patients
A 2-year randomized, placebo-controlled, double-blind, clinical trial involving 146 participants with symptomatic knee OA (mean age, 62.4 years [SD, 8.5]; 57 women [61%], 115 white race [79%]). Patients were enrolled at Tufts Medical Center in Boston between March 2006 and June 2009.
Intervention
Participants were randomized to receive either placebo or oral cholecalciferol, 2000 IU/d, with dose escalation to elevate serum levels to more than 36 ng/mL.
Main outcome measures
Primary outcomes were knee pain severity (Western Ontario and McMaster Universities [WOMAC] pain scale, 0-20: 0, no pain; 20, extreme pain), and cartilage volume loss measured by magnetic resonance imaging. Secondary end points included physical function, knee function (WOMAC function scale, 0-68: 0, no difficulty; 68, extreme difficulty), cartilage thickness, bone marrow lesions, and radiographic joint space width.
Results
Eighty-five percent of the participants completed the study. Serum 25-hydroxyvitamin D levels increased by a mean 16.1 ng/mL (95% CI, 13.7 to 18.6) in the treatment group and by a mean 2.1 mg/mL (95% CI, 0.5 to 3.7) (P < .001) in the placebo group. Baseline knee pain was slightly worse in the treatment group (mean, 6.9; 95% CI, 6.0 to 7.7) than in the placebo group (mean, 5.8; 95% CI, 5.0 to 6.6) (P = .08). Baseline knee function was significantly worse in the treatment group (mean, 22.7; 95% CI, 19.8 to 25.6) than in the placebo group (mean, 18.5; 95% CI, 15.8 to 21.2) (P = .04). Knee pain decreased in both groups by a mean -2.31 (95% CI, -3.24 to -1.38) in the treatment group and -1.46 (95% CI, -2.33 to -0.60) in the placebo group, with no significant differences at any time. The percentage of cartilage volume decreased by the same extent in both groups (mean, -4.30; 95% CI, -5.48 to -3.12 vs mean, -4.25; 95% CI, -6.12 to -2.39) (P = .96). There were no differences in any of the secondary clinical end points.
Conclusion and relevance
Vitamin D supplementation for 2 years at a dose sufficient to elevate 25-hydroxyvitamin D plasma levels to higher than 36 ng/mL, when compared with placebo, did not reduce knee pain or cartilage volume loss in patients with symptomatic knee OA.
Trial registration
clinicaltrials.gov Identifier: NCT00306774.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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