Effect of Vitamin D Supplementation on Tibial Cartilage Volume and Knee Pain Among Patients With Symptomatic Knee Osteoarthritis: A Randomized Clinical Trial
Jin X, Jones G, Cicuttini F, Wluka A, Zhu Z, Han W, Antony B, Wang X, Winzenberg T, Blizzard L, Ding C
JAMA · 151 citas
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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 no declarada
Publicación
- Publicado
- 2016-03-08 · JAMA · vol. 315 · número 10 · pág. 1005
- Editorial
- American Medical Association
- Citado
- 200 citas · más que el 100% de estudios similares · 18.8× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 42 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Vitamin D Research Studies · Osteoarthritis Treatment and Mechanisms · Musculoskeletal pain and rehabilitation
- Palabras clave
- vitamin D supplementation, vitamin D3, knee osteoarthritis, knee pain, 25-hydroxyvitamin D, cartilage defects, bone marrow lesions, WOMAC pain score, adverse events, MRI cartilage assessment
- MeSH
- cartilage, tibia, knee joint, humans, arthralgia, osteoarthritis, knee, cholecalciferol, vitamins, vitamin d, magnetic resonance imaging, pain measurement, drug administration schedule, double-blind method, middle aged, tasmania, victoria, female, male
11 autores
- Xingzhong Jin🇦🇺University of Tasmania; Menzies Institute for Medical Research
- Graeme Jones🇦🇺University of Tasmania; Menzies Institute for Medical Research
- Flavia Cicuttini🇦🇺Monash University
- Anita E. Wluka🇦🇺Monash University
- Zhaohua Zhu🇦🇺University of Tasmania; Menzies Institute for Medical Research
- Weiyu Han🇦🇺University of Tasmania; Menzies Institute for Medical Research
- Benny Antony🇦🇺University of Tasmania; Menzies Institute for Medical Research
- Xia Wang🇦🇺University of Tasmania; Menzies Institute for Medical Research
- Tania Maree Winzenberg🇦🇺University of Tasmania; Menzies Institute for Medical Research
- Leigh Blizzard🇦🇺University of Tasmania; Menzies Institute for Medical Research
- Changhai Ding🇦🇺🇨🇳 · autor de correspondenciaUniversity of Tasmania; Anhui Medical University; First Affiliated Hospital of Anhui Medical University; Menzies Institute for Medical Research; Monash University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Importance
Observational studies suggest that vitamin D supplementation is associated with benefits for knee osteoarthritis, but current trial evidence is contradictory.
Objective
To compare the effects of vitamin D supplementation vs placebo on knee pain and knee cartilage volume in patients with symptomatic knee osteoarthritis and low vitamin D levels.
Design, setting, and participants
A multicenter randomized, double-blind, placebo-controlled clinical trial in Tasmania and Victoria, Australia. Participants with symptomatic knee osteoarthritis and low 25-hydroxyvitamin D (12.5-60 nmol/L) were enrolled from June 2010 to December 2011. The trial was completed in December 2013.
Interventions
Participants were randomly assigned to receive monthly treatment with oral vitamin D3 (50,000 IU; n = 209) or an identical placebo (n = 204) for 2 years.
Main outcomes and measures
Primary outcomes were change in tibial cartilage volume (assessed using magnetic resonance imaging [MRI]) and change in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score (0 [no pain] to 500 [worst pain]) from baseline to month 24. Secondary outcomes were cartilage defects and bone marrow lesions (assessed using MRI).
Results
Of 413 enrolled participants (mean age, 63.2 years; 50% women), 340 (82.3%) completed the study. The level of 25-hydroxyvitamin D increased more in the vitamin D group (40.6 nmol/L) than in the placebo group (6.7 nmol/L) (P < .001) over 2 years. There were no significant differences in annual change of tibial cartilage volume or WOMAC pain score. There were no significant differences in change of tibiofemoral cartilage defects or change in tibiofemoral bone marrow lesions. Adverse events (≥ 1 per patient) occurred in 56 participants in the vitamin D group and in 37 participants in the placebo group (P = .04). [table: see text].
Conclusions and relevance
Among patients with symptomatic knee osteoarthritis and low serum 25-hydroxyvitamin D levels, vitamin D supplementation, compared with placebo, did not result in significant differences in change in MRI-measured tibial cartilage volume or WOMAC knee pain score over 2 years. These findings do not support the use of vitamin D supplementation for preventing tibial cartilage loss or improving WOMAC knee pain in patients with knee osteoarthritis.
Trial registration
clinicaltrials.gov Identifier: NCT01176344; anzctr.org.au Identifier: ACTRN12610000495022.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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