A Study of Vitamin B12 Status in Children With Infantile Tremor Syndrome and Pre Infantile Tremor Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- vitamin b12 status in children with ITS and preITS
研究概览
简要总结
PRIMARY OBJECTIVES
• To describe the vitamin B12 status in children with infantile tremor syndrome(ITS) and Pre ITS
SECONDARY OBJECTIVES
- To study the vitamin B12 status in mothers of children with infantile tremor syndrome (ITS) and Pre ITS
- To study the blood levels of folate in children with infantile tremor syndrome (includes Pre ITS) and their mothers.
详细描述
Materials and methods
STUDY SETTING: Hospital based study (Advanced Pediatrics Centre, PGIMER) STUDY PERIOD: July 2015 to December 2016 STUDY DESIGN: Cross sectional, Observational Enrolment criteria Inclusion criteria (cases)
- Either sex, age less than 3 years
- Clinical diagnosis of Infantile Tremor Syndrome as evidenced by the following features:
[Developmental delay or regression WITH history of exclusive or predominant breast feeding WITH two or more of the following; skin pigmentation, hair depigmentation, tremors] ITS:1 and 2 plus tremors PreITS:1 and 2 without tremors Exclusion criteria (cases)
- Parents refusing consent
- Later confirmation of an alternative diagnosis
- Patient has received oral or injectable Vitamin B12 in the past 6 months Controls (C)- Normally developing children
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria (cases)
- •Either sex, age less than 3 years
- •Clinical diagnosis of Infantile Tremor Syndrome as evidenced by the following features:
- •[Developmental delay or regression WITH history of exclusive or predominant breast feeding WITH two or more of the following; skin pigmentation, hair depigmentation, tremors] ITS:1 and 2 plus tremors PreITS:1 and 2 without tremors
- •Controls (C)- Normally developing children
- •Inclusion criteria Developmentally normal child not suffering from any acute or chronic neurological illness
排除标准
- •Exclusion criteria (cases)
- •Parents refusing consent
- •Later confirmation of an alternative diagnosis
- •Patient has received oral or injectable Vitamin B12 in the past 6 months
- •• Exclusion criteria(controls)
- •Parent/individual refusing consent
- •Patient has received oral or injectable Vitamin B12 in the past 6 months
结局指标
主要结局
vitamin b12 status in children with ITS and preITS
时间窗: July 2015 to December 2016
The blood levels of vitamin B-12 and folate would be expressed as mean ± 2 SD or median (range) and will be compared between the children (with infantile tremor syndrome) and their mothers with controls.
次要结局
- vitamin B12 Status in mothers of children with ITS and preITS folate status in these children and their mothers(July 2015 to December 2016)
研究者
Chaudhary Himanshi
Junior resident
Post Graduate Institute of Medical Education and Research, Chandigarh