Vitamin D supplementation in the management of knee osteoarthritis: study protocol for a randomized controlled trial
Yuelong Cao, Graeme Jones, Flavia Cicuttini, Tania Winzenberg, Anita Wluka, James Sharman, Kay Nguo and Changhai Ding
Trials 2012, 13:131 doi:10.1186/1745-6215-13-131, Published: 6 August 2012
Background
Osteoarthritis (OA) is a common health issue worldwide in the aging population who are also commonly deficient in vitamin D. Our previous study suggested that higher serum 25-(OH)D levels were associated with reduced knee cartilage loss, implying that vitamin D supplementation may prevent the progression of knee OA. The aim of the VItamin D Effects on OA (VIDEO) study is to compare, over a 2- year period, the effects of vitamin D supplementation versus placebo on knee structural changes, knee pain, and lower limb muscle strength in patients with symptomatic knee OA.
Methods
Randomised, placebo-controlled, and double-blind clinical trial aiming to recruit 400 subjects (200 from Tasmania and 200 from Victoria) with both symptomatic knee OA and vitamin D deficiency (serum [25-(OH)D] level of >12.5 nmol/liter and <60 nmol/liter). Participants will be randomly allocated to vitamin D supplementation (50,000 IU compounded vitamin D3 capsule monthly) or identical inert placebo group for 2 years. The primary endpoint is loss of knee cartilage volume measured by magnetic resonance imaging (MRI) and Western Ontario and McMaster Universities Index of OA (WOMAC) knee pain score. The secondary endpoints will be other knee structural changes, and lower limb muscle strength. Several other outcome measures including core muscle images and central blood pressure will be recorded. Linear and logistic regression will be used to compare changes between groups using univariable and multivariable modeling analyses. Both intention to treat and per protocol analyses will be utilized.
Discussion
The trial is designed to test if vitamin D supplementation will reduce loss of knee cartilage volume, prevent the progression of other knee structural abnormalities, reduce knee pain and strengthen lower limb muscle strength, thus modify disease progression in knee OA. Trial Registration: ClinicalTrials.gov identifier: NCT01176344; Australian New Zealand Clinical Trials Registry: ACTRN12610000495022
Provisional PDF is attached at the bottom of this page
VitaminDWiki will be surprised if 50,000 IU of vitamin D monthly will be enough - based on a huge number of previous published studies
That dose taken twice a month might work for half of the people.
See also VitaminDWiki
- Probability of knee osteoarthritis up 50 percent if 20 ng less vitamin D – Nov 2011
- Overview Osteoarthritis and Vitamin D
- Knee osteoarthritis associated with low vitamin D for those under age 55 – Dec 2010
- Osteoarthritis twice as prevalent if vitamin D level less than 15 ng – Feb 2010
- Knee osteoarthritis reduced somewhat by 50,000 IU vitamin D monthly (need more) – RCT Aug 2015
perhaps the results from this RCT