VDR gene polymorphism and Dopaminergic and VDR gene expression in Attention Deficit Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluation of serum Vitamin D levels will help to rule out the deficiency
研究概览
简要总结
Ø Genetics plays an indispensable role in ADHD, so the discovery of genetic variants linked to ADHD susceptibility plays a crucial role in the advancement of preventive medicine. Several clinical studies have proven the beneficial effect of vitamin D on ADHD, but the mechanism behind this is still unclear. The diagnosis of ADHD is mainly focused on the subjective evidence (behavioural changes) of the patients, but so far, no biological markers are in practice for evaluating the disease status, so dopaminergic genes (VDR,SLC6A3, TH, DRD4) expression from PBMC can be a promising biomarker in ADHD. So, by analyzing the serum vitamin D levels, VDR gene polymorphism from the isolated DNA and evaluating the mRNA expression of the dopamine-specific genes helps elucidate the association of vitamin D in the genomic-level alteration of ADHD ultimately aiding in the individualization of treatment modalities accordingly.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 4.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy children (Controls): Children with no current medical illness and family history of any major psychiatric disorder, especially ADHD as defined by ICD-10/ DSM-V.
- •ADHD patients (Cases): Children diagnosed with ADHD by the paediatrician and the clinical psychologist using the Vanderbilt ADHD rating scale and who are on therapy or not.
- •Comorbid with ODD, SLD, and CD will be included.
- •Willing to withdraw blood and participate in the study after giving consent.
- •Responsible caregiver to provide sufficient information about the participant’s functional status.
排除标准
- •History of any neurological disorder and psychiatric conditions involving the brain or other central function (eg: History of brain injury, suspected intellectual disability, autism spectrum disorder, narcolepsy, H/O mental retardation (MR), schizophrenia, mania episode, epilepsy, anxiety disorders, bipolar disorder, active suicidal ideation)
- •Use of Anticoagulants
- •Having any serious medical condition, including inflammatory bowel disease, history of cancer, kidney or liver disease, hyperthyroidism, glaucoma, diabetes or cardiovascular disorders, gallstones, bile duct obstruction, stomach ulcers, or excess stomach acid, abnormality of mineral metabolism eg: Wilson’s disease, hemochromatosis
- •Having any disability that would interfere with participation in the study.
结局指标
主要结局
Evaluation of serum Vitamin D levels will help to rule out the deficiency
时间窗: At the baseline visit alone, the blood samples will be collected. | The serum will be separated for vitamin D estimation and DNA will be isolated for polymorphism analysis.
VDR gene polymorphism analysis will help to identify the alteration in the VDR gene that might affect the bioconversion of vitamin D in ADHD
时间窗: At the baseline visit alone, the blood samples will be collected. | The serum will be separated for vitamin D estimation and DNA will be isolated for polymorphism analysis.
次要结局
- The expression analysis of dopamine-specific genes (TH,DRD4,SLC6A3) & VDR will help to elucidate molecular-level changes that will affect the pathophysiology of ADHD.(The genomic analysis of these ADHD-specific genes can be used as an efficient biomarker for ADHD. It will help to improve the treatment outcome by individualizing the treatment modalities accordingly)
研究者
Dr Jayakumar C
Amrita Institute of Medical Sciences and Research Centre