TABLE 3:

Previous Large RCTs Studying Daily Dosing of Supplemental Vitamin D vs. Placebo on Fracture Outcomes in Community-Dwelling Adults (29,53–56)

Study	Participants/ Duration	Intervention	25 (OH}D Levels	Key Findings
Lips P, et al. Ann Intern Med. 1996	Netherlands: Women and men >70 yrs, independent/residential facilities (n=2,578) Duration: 3.5 yrs	Oral vitamin D3 400 lU/day	Baseline: 10.8 ng/mL in vitamin D group and 10.4 ng/mL in placebo group Follow up (3 vrs): 24.0 ng/mL in vitamin D group	No effect on hip or peripheral fractures
RECORD Grant AM, et al. Lancet. 2005	UK: Women and men >70 yrs (n=5,292) who were mobile before a low-trauma fracture Duration: 24–62 months	Oral vitamin D3800 lU/day, calcium 1000 mg/day, or combination or placebo	Baseline: 15.2±6.5 ng/mL (n=60) Follow up (1 yr): rose by 9.7±8.7 ng/mL in vit D group and by 3.1±7.2 ng/mL in placebo group	No effect on low- trauma fractures
DO-HEALTH, Bischoff-Ferrari H et al. JAMA 2020	Europe: Women and men >70 yrs (n=2,157) Duration: 3 yrs	Oral vitamin D3 2000 lU/day, omega-3 fatty acids 1000 mg/day, and strength- training exercise program alone and in combinations	Baseline: 22.4±8.4 ng/mL Follow up (3 yrs): 37.5 ng/mL in the vitamin D groups and 24.4 ng/mL in the non-vitamin D groups	No effect on non- vertebral fractures or falls
VITAL LeBoff MS, etal. NEJM. 2022	U.S.: Women aged >55 and men aged >50 yrs (n = 25,871) Duration: 5.3 yrs	Oral vitamin D3 2000 lU/day	Baseline: 30.7±10 ng/mL (n=16,757) Follow up (2 yrs): 41.2 ng/mL in vit D group	No effect on total, non-vertebra 1, or hip fractures or falls