维生素D对孕妇睡眠质量和妊娠症状的影响:一项随机、三盲和安慰剂对照的临床试验

Zahra Mirzaei-Azandaryani, Y. Javadzadeh, E. Shaseb, M. Mirghafourvand
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摘要

由于充足的睡眠对生活和健康的重要性,本研究旨在确定补充维生素D对睡眠质量和妊娠症状(主要结局)和副作用(次要结局)的影响。设计/方法/方法本研究采用三盲随机对照临床试验,将88例胎龄为8 ~ 10周、血清维生素D浓度小于30 ng/ml的孕妇采用分组随机法分为维生素D组(n = 44)和对照组(n = 44)。维生素D组每天服用4000国际单位的维生素D药片,对照组每天服用安慰剂,持续18周。采用独立t-检验、Mann-Whitney U检验和ANCOVA检验对数据进行分析。结果:维生素D组和安慰剂组干预后总睡眠质量评分均值(SD:标准差)分别为1.94(2.1)和4.62(1.71)。根据Mann-Whitney U检验,两组之间的差异具有统计学意义(p < 0.001)。维生素D组和安慰剂组妊娠症状的平均(SD)分别为23.95(16.07)和26.62(13.84),经ANCOVA检验,两组间差异无统计学意义(p = 0.56)。在任何组中均未观察到明显的副作用。独创性/价值由于维生素D对睡眠质量的影响与高患病率的睡眠障碍和妊娠症状的矛盾结果,因此进行了本研究。
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The effects of vitamin D on sleep quality and pregnancy symptoms in pregnant women: a randomized, tripled-blinded and placebo-controlled clinical trial
Purpose Because of the importance of having enough sleep in life and health, this study aims to determine the effect of vitamin D supplementation on sleep quality and pregnancy symptoms (primary outcomes) and side effects (secondary outcome). Design/methodology/approach In this triple-blind randomized controlled clinical trial, 88 pregnant women with gestational age of 8–10 weeks and serum vitamin D concentration less than 30 ng/ml were allocated into vitamin D (n = 44) and control (n = 44) groups by blocked randomization method. The vitamin D group received a 4,000 IU vitamin D pill, and the control group received a placebo pill daily for 18 weeks. Independent t-, Mann–Whitney U and ANCOVA tests were used to analyze the data. Findings The post-intervention mean (SD: standard deviation) of total sleep quality score in the vitamin D and placebo group were 1.94 (2.1) and 4.62 (1.71), respectively. According to the Mann–Whitney U test, this difference between the two groups was statistically significant (p < 0.001). The mean (SD) of pregnancy symptoms in the vitamin D and placebo groups was 23.95 (16.07) and 26.62 (13.84), respectively, and there was no significant difference between the two groups based on ANCOVA test (p = 0.56). Considerable side effects were not observed in any groups. Originality/value This study was conducted due to the contradictory results of the effect of vitamin D on sleep quality and the high prevalence of sleep disorders and pregnancy symptoms.
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