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补充维生素D对自闭症谱系障碍儿童炎症状态和行为症状的影响:一项双盲随机临床试验。

Effect of vitamin D supplementation on inflammatory status and behavioral symptoms in children with autism spectrum disorders: a double-blind randomized clinical trial.

作者信息

Javadfar Zohreh, Soltani Shahin, Khamoushi Firoozeh, Sharifi Maryam, Moradi Shima, Rezaeian Shahab, Foroughi Ali Akbar, Cheshmeh Sahar, Taghaddosi Mehdi, Bahrehmand Fariborz

机构信息

Clinical Research Development Center, Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.

Research Center for Environmental Determinants of Health, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.

出版信息

BMC Pediatr. 2025 Aug 8;25(1):615. doi: 10.1186/s12887-025-05985-y.

Abstract

PURPOSE

Inflammation in early childhood has been proposed as a clinically recognized risk factor for developing autism spectrum disorder (ASD). Since vitamin D has an anti-inflammatory role, this trial was aimed to evaluate the effects of vitamin D supplementation on TNF-α and IL-37 status and behavioral problems in children with ASD.

METHODS

This parallel double-blind clinical trial study was conducted on 43 ASD children who were randomly allocated into two studied groups the vitamin D drop group received 300 IU/kg daily ( = 22) and, the control group ( = 21) for 15 weeks. Serum levels of 25(OH) D (ng/ml), and inflammatory indices including tumor necrosis factor-alpha (TNF-α) (ng/ml), and interleukin 37 (IL-37) (ng/ml) were measured at the start and end of the study. Moreover, the Real-Life Rating Scale for Autism (RLRS) questionnaire assessed behavioral symptoms.

RESULTS

Of the participants, 55.6% in the intervention group and 44.4% in the control group were boys ( = 0.24). After 15 weeks of vitamin D supplementation, serum 25(OH) D levels significantly increased ( = 0.001), while TNF-α ( < 0.001) and IL-37 ( = 0.004) levels significantly decreased. The total RLRS score in the intervention group significantly decreased ( = 0.005), but no significant changes were observed in its subcategories (e.g., Sensory Motor Behaviors, Social Relationship to People) due to small, non-significant improvements accumulating to affect the total score. Between-group comparisons for RLRS were non-significant ( = 0.165).

CONCLUSION

The trial highlighted the possible anti-inflammatory role of vitamin D in children with ASD, as well as improving behavioral disorders.

LEVEL OF EVIDENCE

Level I- randomized controlled trial.

TRIAL REGISTRATION

IRCT20170827035936N3, https://irct.behdasht.gov.ir/trial/27012; registration date: 16/09/2023.

SUPPLEMENTARY INFORMATION

The online version contains supplementary material available at 10.1186/s12887-025-05985-y.

摘要

目的

幼儿期炎症被认为是自闭症谱系障碍(ASD)发展的临床公认风险因素。由于维生素D具有抗炎作用,本试验旨在评估补充维生素D对ASD儿童肿瘤坏死因子-α(TNF-α)和白细胞介素-37(IL-37)水平以及行为问题的影响。

方法

本平行双盲临床试验研究对43名ASD儿童进行,这些儿童被随机分为两个研究组,维生素D滴剂组每天接受300 IU/kg(n = 22),对照组(n = 21),为期15周。在研究开始和结束时测量血清25(OH)D水平(ng/ml)以及炎症指标,包括肿瘤坏死因子-α(TNF-α)(ng/ml)和白细胞介素37(IL-37)(ng/ml)。此外,使用自闭症现实生活评定量表(RLRS)问卷评估行为症状。

结果

参与者中,干预组55.6%为男孩,对照组44.4%为男孩(p = 0.24)。补充维生素D 15周后,血清25(OH)D水平显著升高(p = 0.001),而TNF-α(p < 0.001)和IL-37(p = 0.004)水平显著降低。干预组的RLRS总分显著降低(p = 0.005),但其子类别(如感觉运动行为、与他人的社会关系)未观察到显著变化,因为微小的、不显著的改善累积起来影响了总分。RLRS的组间比较无显著差异(p = 0.165)。

结论

该试验突出了维生素D在ASD儿童中可能的抗炎作用以及改善行为障碍的作用。

证据水平

I级 - 随机对照试验。

试验注册

IRCT20170827035936N3,https://irct.behdasht.gov.ir/trial/27012;注册日期:2023年9月16日。

补充信息

在线版本包含可在10.1186/s12887-025-05985-y获取的补充材料。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9028/12333158/58b4c799bd99/12887_2025_5985_Fig1_HTML.jpg

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