Extrait

Background and study aims Vitamin D is essential for healthy bones and muscles, particularly in older people where low levels contribute to weak bones and falls. Although vitamins generally come from the diet, in the case of vitamin D, the majority of people actually get most of it from sunlight. Almost every cell in the body contains a vitamin D receptor that is vital for a variety of functions. Low vitamin D therefore can prevent tissues from carrying out their normal functions, which can lead to a range of long-term health conditions, such as weak bones, heart disease and problems with the immune system. People over the age of 70 slowly lose bone density over time, and vitamin D may help to slow this loss down. The aim of this study is to look at the effectiveness of three doses of vitamin D supplementation to prevent bone loss, given each month for a year on the change in bone density in older adults at risk of vitamin D deficiency. Who can participate? Men and women aged 70 years and over who are living in the community and are able to walk. What does the study involve? Participants are randomly allocated to one of three groups. Each group are given vitamin D supplements to take at different doses. The supplement is in the form of oil which is taken by mouth. There are six study visits during the study, two at the start, then every three months until the last visit at one year later, where participants are given the study supplement, have a blood test taken, and provide a urine sample. Before these visits, participants are asked not to eat anything after 10pm the night before. Participants also undergo two Dexa scans, which measure done density and complete questionnaires about diet and health, quality of life and a sunshine exposure. What are the possible benefits and risks of participating? Not provided at time of registration. Where is the study run from? Newcastle University (UK) When is the study starting and how long is it expected to run for? March 2016 to February 2018 Who is funding the study? Arthritis Research UK (UK) Who is the main contact? Dr Alexander von Wilamowitz-Moellendorff [email protected]

Critère d'inclusion

• Musculoskeletal Diseases

Liens

• ictrp
• isrctn