Effect of Vitamin D Supplementation on Progression of Knee Pain and Cartilage Volume Loss in Patients With Symptomatic Osteoarthritis - A Randomized Controlled Trial
JAMA. 2013;309(2):155-162. doi:10.1001/jama.2012.164487.
Timothy McAlindon, DM, MPH; Michael LaValley, PhD; Erica Schneider, PhD; Melynn Nuite, RN, BS; Ji Yeon Lee, MD, MSc; Lori Lyn Price, MAS; Grace Lo, MD, MSc; Bess Dawson-Hughes, MD
Division of Rheumatology, Tufts Medical Center, Boston, Massachusetts (Drs McAlindon and Lee and Ms Nuite); Boston University School of Public Health, Crosstown Center, Boston, Massachusetts (Dr LaValley); Imaging Institute, Cleveland Clinic Foundation, Cleveland, Ohio (Dr Schneider); Biostatistics Research Center in the Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts (Ms Price); Michael E. DeBakey Veterans Affairs Medical Center, Medical Care Line and Research Care Line; Houston VA Health Services Research and Development Center of Excellence, and Section of Immunology, Allergy, and Rheumatology, Department of Medicine, Baylor College of Medicine, Houston, Texas (Dr Lo); Jean Mayer USDA Human Nutrition Research Center on Aging, at Tufts University, Boston, Massachusetts (Dr Dawson-Hughes).
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
CLICK HERE for Audio and video interviews of the author
PDF is attached at the bottom of this page
Strange aspects of this study
- Subjects getting vitamin D had more pain during entire year than placebo group
- Subjects getting vitamin D had less knee function
- Participants were not given any cofactors – such as Calcium, Magnesium, Vitamin K2, Omega-3, etc
- 39% of vitamin D group did not achieve the 36-100 ng target (mentioned in PDF, not abstract)
- No indication if the individuals who did achieve the 36-100 ng target started with higher levels of vitamin D
- No indication why all participants did not achieve the minimum target, since the doses could be increased during the trail so as to achieve the goal
- 2X as many people in vitamin D group vs placebo needed NSAIDS (pain killers) at month 16
- 8% of the placebo individuals increase vitamin D levels to >36 ng (The trial had no restriction on anyone taking vitamin D for themselves)
See also VitaminDWiki
- Will knee osteoarthritis be prevented with 1700 IU of vitamin D – proposed RCT
- Probability of knee osteoarthritis up 50 percent if 20 ng less vitamin D – Nov 2011
- Overview Osteoarthritis and Vitamin D which had the following summary Jan 2013
Osteoarthritis results from narrowing of joints which are made of cartilage
Vitamin D with co-factors such as Magnesium, Calcium, and vitamin K help build cartilage as well as bone
Vitamin D PREVENTS Osteoarthritis
Vitamin D TREATS Osteoarthritis - provided it has not gone so far that the bones cannot be re-built
Vitamin D can add to bone mass - but it probably cannot re-build bone structure
See review of study at Vitamin D Council
- Most got just 2,000 IU, 18 had dose increreased to 4000 IU, 4 to 6000 IU, and only 1 to 8000.
- It is unlikely that vitamin D can repair worn out joints, although I do find it likely that higher vitamin D doses can help the pain of OA.
In fact, their own study showed that trends favored the treatment group in both pain and functionality
- Medical Press Sept 2015
McAlindon says that a limitation of his clinical trial "is that for ethical reasons, we could not enroll people who are medically deficient in D, so none of the participants was really deficient. Therefore, we couldn't rule out the possibility that people who are extremely deficient in D might experience some benefit from vitamin D."
This filtering of subjects was not mentioned in the abstract. Now the results are understandable