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评价维生素 D 补充对弱精子症不育男性精液和血清氧化应激指标的影响:一项三盲、随机对照试验的研究方案。

Evaluation of the effect of vitamin D supplementation on spermatogram, seminal and serum levels of oxidative stress indices in asthenospermia infertile men: a study protocol for a triple-blind, randomized controlled trial.

机构信息

Department of Nutrition, School of Allied Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.

Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.

出版信息

Nutr J. 2021 Jun 2;20(1):49. doi: 10.1186/s12937-021-00711-7.

DOI:10.1186/s12937-021-00711-7
PMID:34078367
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8173907/
Abstract

BACKGROUND

It is suggested that vitamin D may have a beneficial role in male reproduction. The male reproductive system is a target tissue for vitamin D. This study will aim to evaluate the effects of vitamin D supplementation on sperm parameters, seminal and serum levels of oxidative stress and serum endocrine factors in asthenospermia infertile men.

METHODS/DESIGN: This randomized, triple-blind, placebo-controlled clinical trial will be conducted on 86 infertile men with idiopathic asthenozoospermia (the mobility of sperm < 40% and rapid progressive sperm motility < 32%), with serum levels of vitamin D less than 30 ng / ml in the "Infertility Clinic of Ahvaz Jahad daneshgahi", Iran.

MAIN OUTCOMES MEASURE (S): Demographic data, dietary intake, physical activity, sun exposure, anthropometric indices, serum and seminal levels of MDA (Malondialdehyde), 8-hydroxy-2- Dioxy Guanosine (8-OHDG), Total Antioxidant Capacity (TAC) and calcium, sperm DNA fragmentation index (DFI), serum 25-OHD, luteinizing hormone (LH), follicle-stimulating hormone (FSH), total testosterone (T), estradiol (E2), sex hormone-binding globulin (SHBG), free androgen index (FAI = T/SHBG. 100), T/LH and T/E2 ratios, prolactin (PRO), parathyroid hormone (PTH), osteocalcin (OCN), phosphorus and sperm parameters.

DISCUSSION

The deficiency of vitamin D as an antioxidant is common all over the world. Numerous observational studies have shown a positive association between vitamin D levels and semen quality. However, few clinical studies have been conducted in this area. So considering with the high prevalence of this antioxidant deficiency specifically in infertile men, it seems that the supplementation of vitamin D in infertile men with insufficient levels or deficiency may improve the status of oxidative stress and thereby may affect sperm parameters and endocrine factors involved in male fertility.

TRIAL REGISTRATION

Iran Clinical Trials Registry, ID: IRCT20151128025274N4 , registered on 28 March 2018.

摘要

背景

维生素 D 可能对男性生殖具有有益作用。男性生殖系统是维生素 D 的靶组织。本研究旨在评估维生素 D 补充对弱精子症不育男性精子参数、精液和血清氧化应激及血清内分泌因子的影响。

方法/设计:这项随机、三盲、安慰剂对照临床试验将在伊朗阿瓦士 Jahad daneshgahi 不孕不育诊所招募 86 名特发性弱精子症(精子活力<40%和快速前向运动精子活力<32%)且血清维生素 D 水平<30ng/ml 的不育男性中进行。

主要结局指标

人口统计学数据、饮食摄入、体力活动、日照、人体测量指数、血清和精液中 MDA(丙二醛)、8-羟基-2-二氧鸟苷(8-OHDG)、总抗氧化能力(TAC)和钙、精子 DNA 碎片化指数(DFI)、血清 25-OHD、黄体生成素(LH)、卵泡刺激素(FSH)、总睾酮(T)、雌二醇(E2)、性激素结合球蛋白(SHBG)、游离雄激素指数(FAI= T/SHBG×100)、T/LH 和 T/E2 比值、催乳素(PRO)、甲状旁腺激素(PTH)、骨钙素(OCN)、磷和精子参数。

讨论

维生素 D 作为一种抗氧化剂的缺乏在世界各地都很常见。大量观察性研究表明,维生素 D 水平与精液质量之间存在正相关。然而,在这一领域进行的临床研究很少。因此,考虑到这种抗氧化剂缺乏在不育男性中特别普遍,似乎补充维生素 D 可以改善氧化应激状态,从而可能影响与男性生育力相关的精子参数和内分泌因子。

试验注册

伊朗临床试验注册中心,注册号:IRCT20151128025274N4,注册于 2018 年 3 月 28 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/71be/8173907/5f9a150802a0/12937_2021_711_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/71be/8173907/8432ed776141/12937_2021_711_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/71be/8173907/5f9a150802a0/12937_2021_711_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/71be/8173907/8432ed776141/12937_2021_711_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/71be/8173907/5f9a150802a0/12937_2021_711_Fig2_HTML.jpg

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