Randomised controlled trial of calcium and supplementation with cholecalciferol (vitamin D 3 ) for prevention of fractures in primary care
- 28 April 2005
- Vol. 330 (7498), 1003
- https://doi.org/10.1136/bmj.330.7498.1003
Abstract
To assess whether supplementation with calcium and cholecaliferol (vitamin D3) reduces the risk of fracture in women with one or more risk factors for fracture of the hip. Pragmatic open randomised controlled trial. Practice nurse led clinics in primary care. 3314 women aged 70 and over with one or more risk factors for hip fracture: any previous fracture, low body weight (< 58 kg), smoker, family history of hip fracture, or fair or poor self reported health. Daily oral supplementation using 1000 mg calcium with 800 IU cholecaliferol and information leaflet on dietary calcium intake and prevention of falls, or leaflet only (control group). Primary outcome measure was all clinical fractures and secondary outcome measures were adherence to treatment, falls, and quality of life (measured with the SF-12). 69% of the women who completed the follow-up questionnaire at 24 months were still taking supplements (55% with inclusion of randomised participants known to be alive). After a median follow-up of 25 months (range 18 to 42 months), clinical fracture rates were lower than expected in both groups but did not significantly differ for all clinical fractures (odds ratio for fracture in supplemented group 1.01, 95% confidence interval 0.71 to 1.43). The odds ratio for hip fracture was 0.75 (0.31 to 1.78). The odds of a woman having a fall at six and 12 months was 0.99 and 0.98, respectively. Quality of life did not significantly differ between the groups. We found no evidence that calcium and vitamin D supplementation reduces the risk of clinical fractures in women with one or more risk factors for hip fracture. Registration ISRCTN26118436, controlled trials registry.Keywords
This publication has 16 references indexed in Scilit:
- Effect of Vitamin D on FallsJAMA, 2004
- Vitamin D and Calcium Supplementation Prevents Osteoporotic Fractures in Elderly Community Dwelling Residents: A Pragmatic Population-Based 3-Year Intervention StudyJournal of Bone and Mineral Research, 2004
- Effect of four monthly oral vitamin D3 (cholecalciferol) supplementation on fractures and mortality in men and women living in the community: randomised double blind controlled trialBMJ, 2003
- Can Vitamin D Supplementation Reduce the Risk of Fracture in the Elderly? A Randomized Controlled TrialJournal of Bone and Mineral Research, 2002
- Combined Calcium and Vitamin D3 Supplementation in Elderly Women: Confirmation of Reversal of Secondary Hyperparathyroidism and Hip Fracture Risk: The Decalyos II StudyOsteoporosis International, 2002
- Improving the measurement of quality of life in older people: the York SF-12QJM: An International Journal of Medicine, 2001
- Validity of Self-reported Diagnoses Leading to Hospitalization: A Comparison of Self-reports with Hospital Records in a Prospective Study of American AdultsAmerican Journal of Epidemiology, 1998
- Effect of Calcium and Vitamin D Supplementation on Bone Density in Men and Women 65 Years of Age or OlderNew England Journal of Medicine, 1997
- Secular trends in proximal femoral fracture, Oxford record linkage study area and England 1968-86.Journal of Epidemiology and Community Health, 1997
- Unequal Randomisation Can Improve the Economic Efficiency of Clinical TrialsJournal of Health Services Research & Policy, 1997