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Dose ranging effects of Vitamin D3 on the Geriatric Depression Score: A Clinical Trial

机译:维生素D3对老年抑郁评分的剂量范围影响:一项临床试验

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摘要

Depression is a common problem affecting millions, usually treated with selective serotonin uptake inhibitors. Interest in vitamin D as a co-therapy was stimulated by some association studies that correlated depression with low serum 25OHD levels. There are few longitudinal studies of vitamin D and depression and most are single doses of vitamin D. In this study we examined the effect of one-year treatment with several doses of vitamin D on the Geriatric depression score (GDS) in older Caucasian and African American women. The clinical trial was a study of seven daily oral doses of vitamin D (400-4800IU/d) in Black and White older women. The trial was a double blind, randomized and placebo controlled lasting 12-months. The main inclusion criterion was serum 25 hydroxyvitamin D (25OHD) ≤ 20ng/ml (50nmo/L). Calcium supplements were given to maintain calcium intake 1000 mg in young people and 1200–1400 mg/day in older women. Data on Geriatric depression (GDS) was collected using the validated long form at baseline and 12-months. The change in serum 25OHD was the primary outcome and GDS was one of the secondary outcomes. Adjustments were made for relevant covariates. Analysis of vitamin D effect was by dose low, medium and high compared to placebo or by quintiles. Serum 25OHD increased as a quadratic curve function to a mean of 46 ng/ml (115nmol/l) in white women and 49ng/ml (122.5nmol/L) in black women on the highest dose of 4800 IU. In older women mean GDS scores changed from 3.8 (SD±4.2) at baseline to 3.6 (SD±4.1) at 12 months in whites and from 3.0 (SD±3.7) to 3.02 (SD±4.2) in Blacks. (p = 0.790 in whites; p=0.958 in blacks). After 12-months there was no effect of dose on change in GDS score in women treated with different doses of vitamin D (p=0.507 in whites and p=0.340 in blacks). When both Caucasians and African Americans were divided into 3 dose groups, low (400-800 IU), medium (1600-3200 IU) and high (4000-4800 IU) doses, the change in score was 0.8 on low dose, −0.30 on medium dose and −0.31 on high dose compared to 0.11 on placebo (p=0.546). In summary, there was no improvement in GDS scores in Caucasians or African Americans on either increasing doses of vitamin D or quintiles of achieved response in serum 25OHD. The changes were small and not significant perhaps because of the relatively lower numbers of depressed women in the groups. Further studies should recruit larger numbers, 3 dose groups covering a serum25OHD range of 20–60ng/ml and more subjects with clinical depression in order to fully address the question of vitamin D effects on depression.
机译:抑郁症是困扰数百万人的常见问题,通常使用选择性5-羟色胺摄取抑制剂治疗。一些将抑郁症与低血清25OHD水平相关联的关联研究激发了人们对维生素D作为辅助疗法的兴趣。很少有关于维生素D和抑郁症的纵向研究,而大多数是单剂量的维生素D。在这项研究中,我们研究了多剂量的维生素D一年治疗对老年白种人和非洲人的老年抑郁评分(GDS)的影响。美国妇女。临床试验是一项针对黑人和白人老年妇女每日口服7剂维生素D(400-4800IU / d)的研究。该试验为双盲,随机,安慰剂对照,持续12个月。主要纳入标准为血清25羟维生素D(25OHD)≤20ng / ml(50nmo / L)。钙补充剂可以使年轻人维持钙摄入量1000 mg,而老年妇女则维持每天1200-1400 mg。在基线和12个月使用经过验证的长格式收集有关老年抑郁症(GDS)的数据。血清25OHD的变化是主要结果,而GDS是次要结果之一。对相关协变量进行了调整。维生素D效果的分析是通过与安慰剂或五分位数相比的低,中和高剂量进行的。在最高剂量为4800 IU的白人女性中,血清25OHD作为二次曲线函数增加至平均值为46 ng / ml(115nmol / l),在黑人女性中为49ng / ml(122.5nmol / L)。老年妇女的平均GDS评分从基线时的3.8(SD±4.2)变为白人12个月时的3.6(SD±4.1),而黑人从3.0(SD±3.7)变为3.02(SD±4.2)。 (白人中p = 0.790;黑人中p = 0.958)。 12个月后,用不同剂量的维生素D治疗的女性剂量对GDS评分的变化无影响(白人中p = 0.507,黑人中p = 0.340)。将高加索人和非裔美国人分为三个剂量组:低剂量(400-800 IU),中剂量(1600-3200 IU)和高剂量(4000-4800 IU),低剂量时得分变化为0.8,-0.30中等剂量时为-0.31,高剂量时为-0.31,而安慰剂为0.11(p = 0.546)。总之,在高加索人或非裔美国人中,无论是增加维生素D剂量还是在血清25OHD中达到应答的五分之一,GDS评分均无改善。变化很小,并不明显,也许是因为这些群体中抑郁妇女的数量相对较少。进一步的研究应招募更多的3个剂量组,涵盖25OHD范围为20-60ng / ml的血清,以及更多患有临床抑郁症的受试者,以便全面解决维生素D对抑郁症的影响问题。

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