Mobarhan 1984.
Methods | Randomised clinical trial with parallel group design (3 groups). | |
Participants | 18 men, aged 32 to 61 years, mean age 52 years, with alcoholic cirrhosis. Inclusion criteria: men with advanced biopsy‐confirmed alcoholic cirrhosis with low levels of serum 25‐hydroxyvitamin D (< 20 ng/mL) and decreased bone density (i.e. > 1.5 standard deviations below mean of healthy Baltimore men of same ages). Exclusion criteria: history of corticosteroid, anticonvulsant, or vitamin D intake; renal disease. |
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Interventions |
Intervention 1: vitamin D2 50,000 IU 2 or 3 times weekly (n = 6). Intervention 2: 25‐hydroxyvitamin D3 800 IU/day to 2000 IU/day (prepared and supplied as identical soft elastic capsules (20 or 50 μg) by Upjohn Co.) (n = 6). Control: no intervention (n = 6). For 1 year. |
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Outcomes | Outcomes reported in abstract of publication. Primary outcomes: bone mineral density. Secondary outcomes: none stated. |
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Stated aim of study | To compare the efficacy of 25‐hydroxyvitamin D3 or vitamin D2 in correcting the bone disease of people with alcoholic cirrhosis. | |
Notes | This study was supported by grants from Upjohn Co. and the Veterans Administration. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The method of sequence generation was not specified. |
Allocation concealment (selection bias) | Unclear risk | The method used to conceal the allocation was not described so that intervention allocations may have been foreseen in advance of, or during, enrolment. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding, and the outcome was likely to be influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of outcome assessment, and the outcome measurement is likely to be influenced by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data were unlikely to make treatment effects depart from plausible values. |
Selective reporting (reporting bias) | Low risk | All clinically relevant and reasonably expected outcomes were reported. |
For‐profit bias | High risk | The trial is sponsored by the industry. |
Other bias | Low risk | The trial appeared to be free of other factors that could put it at risk of bias. |