Methods and procedures for: A randomized double-blind study investigating dose-dependent longitudinal effects of vitamin D supplementation on bone health

Contemporary Clinical Trials
L A BurtDavid A Hanley

Abstract

The optimum dose of vitamin D and corresponding serum 25-hydroxyvitamin D (25OHD) concentration for bone health is still debated and some health practitioners are recommending doses well above the Canada/USA recommended Dietary Reference Intake (DRI). We designed a three-year randomized double-blind clinical trial investigating whether there are dose-dependent effects of vitamin D supplementation above the Dietary Reference Intake (DRI) on bone health. The primary aims of this study are to assess, whether supplementation of vitamin D3 increases 1) volumetric bone mineral density measured by high-resolution peripheral quantitative computed tomography (HR-pQCT); 2) bone strength assessed by finite element analysis, and 3) areal bone mineral density by dual X-ray absorptiometry (DXA). Secondary aims are to understand whether vitamin D3 supplementation improves parameters of bone microarchitecture, balance, physical function and quality of life. Participants are men and women aged 55-70 years, with women at least 5-years post-menopause. The intervention is daily vitamin D3 supplementation doses of 400, 4000 or 10,000 IU. Participants not achieving adequate dietary calcium intake are provided with calcium supplementation, up to a ma...Continue Reading

Associated Clinical Trials

Jul 17, 2013·David A. Hanley, MD, FRCPC

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Citations

Aug 28, 2019·JAMA : the Journal of the American Medical Association·Lauren A BurtSteven K Boyd
Nov 21, 2019·The Journal of Clinical Endocrinology and Metabolism·Emma O BillingtonDavid A Hanley
Aug 11, 2020·Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research·Lauren A BurtSteven K Boyd
May 21, 2020·Osteoporosis International : a Journal Established As Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA·T D KempS K Boyd
Jun 20, 2020·Osteoporosis International : a Journal Established As Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA·E O BillingtonD A Hanley
Feb 25, 2021·Osteoporosis International : a Journal Established As Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA·R M PlettS K Boyd

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