Selenium supplementation to improve bone health in postmenopausal women: the SeMS three-arm RCT

Background Observational and pre-clinical studies have reported an association between selenium status, bone density, turnover fracture risk. Selenium is anti-oxidant, so we hypothesised that could reduce the pro-resorptive action of reactive oxygen species on osteoclasts. Population mortality data suggest optimum range for serum 120–150 µg/l. Most adults in Europe are relatively insufficient compared with USA other geographical areas. Objectives The objectives study were to determine if supplementation postmenopausal women osteopenia decreased turnover, improved physical function or markers oxidative stress inflammation. Design We conducted a 6-month double-blind, randomised, placebo-controlled trial. Setting This was single-centre Sheffield, UK. Participants recruited 120 osteoporosis. One hundred fifteen completed follow-up included intention-to-treat analysis. Interventions interventions sodium selenite as Selenase 200 µg/day, 50 µg/day (biosyn, Germany) placebo. Main outcome measures primary end point urine N–terminal cross-linking telopeptide type I collagen/Cr (NTX/Cr) at 26 weeks. Groups analysis covariance, through use Hochberg testing. Secondary points biochemical mineral density by dual-energy X-ray absorptiometry scores (short performance battery grip strength). mechanistic inflammation anti-oxidant activity (glutathione peroxidase, highly sensitive C-reactive protein interleukin 6). Results In group, mean increased from 78.8 µg/l (95% confidence interval 73.5 84.2 µg/l) 105.7 99.5 111.9 Urine NTX/Cr did not differ treatment groups None secondary end-point measurements differed Conclusions conclude these doses does affect (assessed NTX/Cr) beneficial musculoskeletal health women. Trial registration IRAS 200308, EudraCT 2016-002964-15 ClinicalTrials.gov NCT02832648. Funding project funded Efficacy Mechanism Evaluation (EME) programme, MRC National Institute Health Research (NIHR) partnership. will be published full ; Vol. 8, No. 6. See NIHR Journals Library website further information.