METHODS: We conducted a randomized double-blinded placebo-controlled clinical trial for 12 weeks, involving 120 pre-frail older adults who were randomized to the cholecalciferol group (cholecalciferol 4000 IU/day) or the placebo group. All subjects were given calcium lactate 500 mg/day. Hand grip strength and walking speed, as primary outcomes, were analyzed using intention-to-treat analysis. The expression of VDR, IGF-1 and IL-6 in monocytes, as secondary outcomes, were analyzed using per-protocol analysis.
RESULTS: After a 12-week intervention, there was a significant increase in serum 25(OH)D levels in both groups, with the increase being higher in the cholecalciferol group than in the placebo group (49.05 vs. 24.01 ng/mL; P < 0.001). No statistically significant differences were observed in hand grip strength (P = 0.228) and walking speed (P = 0.734) between the groups. There were no differences in the expression of VDR (P = 0.513), IL-6 (P = 0.509), and IGF-1 (P = 0.503) monocytes between the groups.
CONCLUSIONS: Cholecalciferol supplementation for 12 weeks increased serum 25(OH)D levels among pre-frail older adults. However, it did not improve hand grip strength and walking speed, and nor did it change the expression of VDR, IL-6, and IGF-1 in monocytes. Geriatr Gerontol Int 2024; 24: 554-562.
方法:我们进行了一项为期12周的随机双盲安慰剂对照临床试验,纳入120名衰弱前的老年人,他们被随机分配到胆钙化醇组(胆钙化醇4000IU/天)或安慰剂组。所有受试者给予乳酸钙500mg/天。手的握力和行走速度,作为主要结果,使用意向治疗分析进行分析。VDR的表达,单核细胞中的IGF-1和IL-6,作为次要结果,使用符合方案分析进行分析。
结果:经过12周的干预,两组血清25(OH)D水平均有显著升高,胆钙化醇组的增加量高于安慰剂组(49.05vs.24.01ng/mL;P<0.001)。两组间的手握力(P=0.228)和步行速度(P=0.734)差异无统计学意义。VDR的表达差异无统计学意义(P=0.513)。IL-6(P=0.509),各组间单核细胞IGF-1(P=0.503)。
结论:12周补充胆钙化醇可增加体弱前老年人的血清25(OH)D水平。然而,它没有提高手的握力和步行速度,它也没有改变VDR的表达,单核细胞中的IL-6和IGF-1。GeriatrGerontolInt2024;••:••-•。