KARAOKE: Krill oil versus placebo in the treatment of knee osteoarthritis: protocol for a randomised controlled trial.

BACKGROUND: Knee osteoarthritis (OA) is a common and important cause of pain and disability, but interventions aimed at modifying structures visible on imaging have been disappointing. While OA affects the whole joint, synovitis and effusion have been recognised as having a role in the pathogenesis of OA. Krill oil reduces knee pain and systemic inflammation and could be used for targeting inflammatory mechanisms of OA. METHODS/DESIGN: We will recruit 260 patients with clinical knee OA, significant knee pain and effusion-synovitis present on MRI in five Australian cities (Hobart, Melbourne, Sydney, Adelaide and Perth). These patients will be randomly allocated to the two arms of the study, receiving 2 g/day krill oil or inert placebo daily for 6 months. MRI of the study knee will be performed at screening and after 6 months. Knee symptoms, function and MRI structural abnormalities will be assessed using validated methods. Safety data will be recorded. Primary outcomes are absolute change in knee pain (assessed by visual analog score) and change in size of knee effusion-synovitis over 24 weeks. Secondary outcomes include improvement in knee pain over 4, 8, 12, 16 and 20 weeks. The primary analyses will be intention-to-treat analyses of primary and secondary outcomes. Per protocol analyses adjusting for missing data and for treatment compliance will be performed as the secondary analyses. DISCUSSION: This study will provide high-quality evidence to assess whether krill oil 2 g/day reduces pain and effusion-synovitis size in older adults with clinical knee OA and knee effusion-synovitis. If krill oil is effective and confirmed to be safe, we will provide compelling evidence that krill oil improves pain and function, changes disease trajectory and slows disease progression in OA. Given the lack of approved therapies for slowing disease progression in OA, and moderate cost of krill oil, these findings will be readily translated into clinical practice. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12616000726459. Registered on 02 June 2016. Universal Trial Number (UTN) U1111-1181-7087.

Analysis of hospital cost outcome of DHA-rich fish-oil supplementation in pregnancy: Evidence from a randomized controlled trial.

OBJECTIVE: Recent research emphasized the nutritional benefits of omega-3 long chain polyunsaturated fatty acids (LCPUFAs) during pregnancy. Based on a double-blind randomised controlled trial named "DHA to Optimize Mother and Infant Outcome" (DOMInO), we examined how omega 3 DHA supplementation during pregnancy may affect pregnancy related in-patient hospital costs. METHOD: We conducted an econometric analysis based on ordinary least square and quantile regressions with bootstrapped standard errors. Using these approaches, we also examined whether smoking, drinking, maternal age and BMI could influence the effect of DHA supplementation during pregnancy on hospital costs. RESULTS: Our regressions showed that in-patient hospital costs could decrease by AUD92 (P<0.05) on average per singleton pregnancy when DHA supplements were consumed during pregnancy. Our regression results also showed that the cost savings to the Australian public hospital system could be between AUD15 - AUD51 million / year. CONCLUSION: Given that a simple intervention like DHA-rich fish-oil supplementation could generate savings to the public, it may be worthwhile from a policy perspective to encourage DHA supplementation among pregnant women.