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临床试验/CTRI/2023/08/057042
CTRI/2023/08/057042尚未招募2/3 期

Effect of adjunctive vitamin D supplementation as measured by serum vitamin D And NGF levels in Autism Spectrum Disorder: An Open-label trial.

Central Institute of Psychiatry1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年5月9日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
32
试验地点
1
主要终点
EFFECT OF ADJUNCTIVE VITAMIN D SUPPLEMENTATION IN Patients of AUTISM SPECTRUM DISORDER as measured by ABC & ISAA scales

研究概览

简要总结

Studies have established that vitamin D deficiency is one of the risk factors of evolutional neuropsychological disorders including autism (Canell, 2008;Eyeles et al., 2013;Saad et al., 2016) with a few denying the possibility of a deficiency(Molloy et al., 2010; Hashemzadeh et al.,2015) . To date there are twelve human clinical trials on Vitamin D supplementation in ASD (Kittana etal., 2021) which have methodological shortcomings related to study design (case series)(Saad et al.,2016), non- adherence to standard dosing guidelines. (Feng et al., 2017;Bleizgys a,2021)Use of concurrent supplementation (omega fatty acids) and lack of positive correlation between vitamin D level and severity of ASD (Javadfar et al 2020;Mazahery et al., 2019).There is just single study finding NGF levels to be significantly increased in the vitamin D supplementation group in ASD (Ucuz et al., 2014).We therefore decided to conduct present study to evaluate the usefulness of vitamin D Supplementation in ASD, the effects of which are being measured by assessing the serum levels of 25 hydroxycholecalciferol and NGF

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
4.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • 1.Children diagnosed with autism spectrum disorder as per ICD
  • 2.Childrenwith ASD who are drug naïve or drug free for 2 weeks.
  • 3.Children of either gender up to 10 years of age.

排除标准

  • 1.Children with known genetic or neurological syndrome with an established link to Autism, history of epilepsy or current seizures, significant medical illness (endocrinopathies), pre-existing liver or kidney disease: sensory or motor impairment that would interfere with the valid completion of study measures.
  • 2.Ongoing use of antiepileptics, steroids, immunosuppressants, bisphosphonates, calcium and vitamin supplements.

结局指标

主要结局

EFFECT OF ADJUNCTIVE VITAMIN D SUPPLEMENTATION IN Patients of AUTISM SPECTRUM DISORDER as measured by ABC & ISAA scales

时间窗: baseline 4 week 12 week

次要结局

  • serum NGF(baseline 12week)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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