评估ω-3脂肪酸联合维生素D3与单独使用维生素D3对雌二醇水平的影响：一项针对维生素D缺乏女性的随机、安慰剂对照试验。
Assessing the effect of omega-3 fatty acid combined with vitamin D3 versus vitamin D3 alone on estradiol levels: a randomized, placebo-controlled trial in females with vitamin D deficiency.
作者信息
Al-Shaer Amani H, Abu-Samak Mahmoud S, Hasoun Luai Z, Mohammad Beisan A, Basheti Iman A
机构信息
Department of Clinical Pharmacy and Therapeutics, Applied Science Private University, Amman, Jordan,
Department of Physiological Sciences, Fakeeh College for Medical Sciences, Jeddah, Kingdom of Saudi Arabia.
出版信息
Clin Pharmacol. 2019 Feb 4;11:25-37. doi: 10.2147/CPAA.S182927. eCollection 2019.
PURPOSE
Outcomes investigating the effect of vitamin D3 (VD3) and omega-3 fatty acids (Omega-3FA) on serum estradiol (E2) are scarce and conflicting. No previous study has investigated the effect of VD3 combination with Omega-3FA on E2 levels. This study was designed to investigate the effect of VD3, Omega-3FA and VD3 plus Omega-3FA on serum E2 levels in premenopausal females diagnosed with vitamin D deficiency (VDD).
SUBJECTS AND METHODS
This randomized, placebo-controlled clinical trial was designed to evaluate the effects of 50,000 IU VD3 taken weekly, 300 mg Omega-3FA taken daily and their combination by the study participants for 8 weeks. The mid-follicular serum levels of E2 and 25-hydroxy vitamin D (25OHD) were assessed at 8 weeks. The study was conducted during winter on a convenience sample of healthy premenopausal Jordanian females with diagnosed VDD. Fasting serum levels for 25OHD and E2 were assessed at baseline and the end of the trial (after 8 weeks). Data were entered into SPSS and analyzed.
RESULTS
Healthy premenopausal Jordanian females (N=86) with diagnosed VDD, mean age 32.8±8.9 years, were recruited into the study. Supplementation of VD3 alone resulted in a significant increase in serum 25OHD (13.4±7.9-28.2±7.1 ng/mL, <0.001) and a significant decrease in E2 levels (85.7±16.5-60.3±20.6 pg/mL, =0.001). Omega-3FA intake led to a significant decrease in serum 25OHD levels (21.2±12.8-13.6±9.2 ng/mL, =0.001) and a significant increase in E2 levels (56.3±19.2-78.4±23.7 pg/mL, =0.006). Combination therapy (VD3 plus Omega-3FA) resulted in a significant increase in both 25OHD (12.0±4.7-35.1±9.5 ng/mL, <0.001) and E2 (43.0±23.4-57.3±31.5 pg/mL, =0.028) levels.
CONCLUSION
Results of this study provide vital insight into the effects of D3, Omega-3FA and a combination of their supplementation on premenopausal Jordanian females with diagnosed VDD. Eight weeks of therapy led to decreased E2 level by VD3 and increased level by Omega-3FA supplementation. With regard to 25OHD, its level was increased by VD3 and decreased by Omega-3FA supplementation. Combination of VD3 plus Omega-3FA increased the levels of both E2 and 25OHD.
TRIAL REGISTRATION
This trial was registered at clinicaltrials.gov as NCT03333564.
目的
关于维生素D3（VD3）和ω-3脂肪酸（Omega-3FA）对血清雌二醇（E2）影响的研究结果较少且相互矛盾。此前尚无研究探讨VD3与Omega-3FA联合使用对E2水平的影响。本研究旨在调查VD3、Omega-3FA以及VD3与Omega-3FA联合使用对诊断为维生素D缺乏（VDD）的绝经前女性血清E2水平的影响。
受试者与方法
本随机、安慰剂对照临床试验旨在评估研究参与者每周服用50,000 IU VD3、每日服用300 mg Omega-3FA及其联合使用8周的效果。在第8周时评估卵泡中期血清E2和25-羟基维生素D（25OHD）水平。该研究在冬季对诊断为VDD的健康绝经前约旦女性的便利样本进行。在基线和试验结束时（8周后）评估25OHD和E2的空腹血清水平。数据录入SPSS并进行分析。
结果
招募了诊断为VDD的健康绝经前约旦女性（N = 86），平均年龄32.8±8.9岁。单独补充VD3导致血清25OHD显著升高（13.4±7.9 - 28.2±7.1 ng/mL，<0.001），E2水平显著降低（85.7±16.5 - 60.3±20.6 pg/mL，=0.001）。摄入Omega-3FA导致血清25OHD水平显著降低（21.2±12.8 - 13.6±9.2 ng/mL，=0.001），E2水平显著升高（56.3±19.2 - 78.4±23.7 pg/mL，=0.006）。联合治疗（VD3加Omega-3FA）导致25OHD（12.0±4.7 - 35.1±9.5 ng/mL，<0.001）和E2（43.0±23.4 - 57.3±31.5 pg/mL，=0.028）水平均显著升高。
结论
本研究结果为VD3、Omega-3FA及其联合补充对诊断为VDD的绝经前约旦女性的影响提供了重要见解。八周的治疗导致VD3使E2水平降低，而补充Omega-3FA使E2水平升高。关于25OHD，VD3使其水平升高，而补充Omega-3FA使其水平降低。VD3与Omega-3FA联合使用使E2和25OHD水平均升高。
试验注册
本试验在clinicaltrials.gov上注册，注册号为NCT03333564。
Zotero 插件