Table 3.
Details of the randomized clinical trials.
| Studies | Country/Sites | Total number of patients/Subgroups | 25- hydroxy vitD level (standard deviation in nmol/liter) | Study design | Follow-up | Vit D form and dose | Duration of therapy | Primary outcomes | Secondary outcomes |
|---|---|---|---|---|---|---|---|---|---|
| Gallagher 2001 | USA | Vit-D: 203 Placebo: 213 Total: 416 |
Initial: Vit-D: 79 (25.5) Placebo: 78.9 (25.9) |
Randomized, double blinded, placebo controlled trial | 3 years | Calcitriol (0.25ug twice daily), | 3 years | Bone mineral density of: -Femoral neck - Spine. |
Bone mineral density of: -Trochanter -Total hip -Total body -Radius |
| Trivedi 2003 | UK | Vit-D: 1,345 Placebo: 1,341 Total: 2,686 |
Post treatment levels: Vit D: 72.0 (22.5) Placebo: 45.37 (17.6) |
Randomized, double blinded, Placebo controlled trial | 5 years | 100,000 IU cholecalciferol every 4 months | 5 years | -Fracture incidence –Total mortality by cause |
NA |
| Lappe 2007 | USA | Vit-D: 446 Placebo: 733 Total: 1,179 |
Initial: Vit-D: 71.8 (20) Placebo: 71.9 (20.6) 12 month change: Vit D: 96.0 (21.4) Placebo: 71 (20.1) |
Randomized, double blinded, placebo-controlled trial. | 4 years | 1100 IU Cholecaliferol every 6 months | 7 years | Reduction in total mortality. | Reduction in total mortality. |
| Lacroix 2009 | USA | Vit-D: 18,176 Placebo: 18,106 Total: 36,282 |
- | Randomized, double blinded, placebo-controlled trial | 7 years | 400 IU Cholecaliferol daily | 4 years | Hip fracture prevention | -Other fracture prevention -Colorectal cancer prevention |
| Sanders 2010 | Australia | Vit-D: 1,131 Placebo: 1,125 Total: 2,256 |
Initial: Vit-D Median (IQR): 53 (40–65) Placebo Medium (IQR): 45 (40–57) |
Randomized, double blinded, placebo controlled trial | 5 years | 500,000 IU Cholecalciferol per year | 3–5 years | Incidence of falls and fractures | Incidence of falls |
| Avenell 2012 | UK | Vit-D: 2,649 Placebo: 2,643 Total: 5,292 |
Initial: accumulative 38 nmol/liter Post treatment levels in Vit D group: 62 nmol/liter |
2X2 factorial, randomized controlled trial | 3 years | 800 IU Cholecalciferol per day | 3 years | All cause mortality, vascular disease mortality, cancer mortality and cancer incidence. | Mortality from -Cardiovascular -Cerebrovascular |
| Baron 2015 | USA | Vit-D: 1,130 Placebo: 1,129 Total: 2,259 |
Initial: Vit-D: 59 (22.2) Placebo: 60.2 (21.9) |
Randomized, double-blinded, placebo controlled trial | 5 years | 1,000 IU Cholecalciferol per day | 3 or 5 years | Recurrent colorectal adenomas | NA |
| Jorde 2016 | Norway | Vit-D: 256 Placebo: 255 Total: 511 |
Initial: Vit-D: 59.9 (21.9) Placebo: 61.1 (21.2) 5-year visit: Vit D: 122.3 (25.3) Placebo: 66.7 (18.6) |
Randomized, double blinded, placebo controlled trial | 5 years | 20,000 IU Cholecalciferol per week | 5 years | Progression to Diabetes Mellitus Type II | Change in -Glucose levels, -Insulin resistance, -Serum lipids, -Blood pressure. |
| Lappe 2017 | USA | Vit-D: 1,156 Placebo: 1,147 Total: 2,303 |
Initial: Vit-D Median (IQR): 82 (80–84) Placebo Medium (IQR): 82 (80–85) Post treatment: Vit-D Median (IQR): 108 (107–111) Placebo Medium (IQR): 79 (77–80) |
Randomized double blinded, placebo-controlled trial | 4 years | 2,000 IU Cholecalciferol per week | 4 years | Incidence of all-type cancer | Hypertension, cardiovascular disease, osteoarthritis, colonic adenomas and diabetes, upper respiratory tract infections, and falls. |
| Manson 2018 | USA | Vit-D: 12,927 Placebo: 12,944 Total: 25,871 |
Initial: Accumulated: 77 (24.1) 1-year visit: Vit D: 104 (25.3) Placebo: 75.3 (23.8) |
2X2 factorial, randomized placebo controlled trial | 5.3 years | 2,000 IU Cholecalciferol per day | 5.3 years | Invasive cancer of any type and major cardiovascular events | Included site-specific cancers, death from cancer, and additional cardiovascular events |
Abbreviations: Vit D: Vitamin D; IQR: interquartile range; IU: international unit; NA: not applicable.