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