Trivedi 2003.
Study characteristics | ||
Methods | Participants and investigators blinded until study ended, when pharmacy revealed coding 2055 of 2686 completed | |
Participants | Community‐based study, UK
2686 (2037 men and 649 women) mean 75 years, from register of British doctors and register of a general practice Inclusion criteria: age 65 to 85 years, living in the community, from British doctors' study register and general practice register in Ipswich Disease exclusions: contraindications to vitamin D supplementation e.g. renal stones, sarcoidosis, malignancy Drug exclusions: already taking vitamin D supplements |
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Interventions | 1. Vitamin D3 (cholecalciferol) 100,000 IU
Randomised 1345, completed 1038 2. Placebo: 1 capsule 4‐monthly Randomised 1341, completed 1017 Duration of treatment 5 years |
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Outcomes | 1. Non‐vertebral fractures at 5 years 2. Hip fractures at 5 years 3. Vertebral fractures at 5 years 4. Falls 5. Self‐reported health 6. In a subgroup, 238 had measurement of PTH, 25(OH)D and heel ultrasound at 4 years 7. Compliance with trial medication 8. Adverse effects: death, death from cardiovascular disease, death from cancer | |
Notes | Discrepancy between text and table 5 in subgroup study (235 and 238 respectively) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | States "randomised", no other information provided |
Allocation concealment (selection bias) | Low risk | Study conducted by post, states "participants and investigators were blinded to the treatment until the study ended, when Ipswich Pharmacy revealed the coding" |