Status:
COMPLETED
A Study of Vitamin B12 Status in Children With Infantile Tremor Syndrome and Pre Infantile Tremor Syndrome
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Infant Nutrition Disorder
Eligibility:
All Genders
6-3 years
Brief Summary
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 wit...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Exclusion criteria (cases)
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- 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
Key Trial Info
Start Date :
July 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT02762682
Start Date
July 1 2015
End Date
December 1 2016
Last Update
December 28 2016
Active Locations (1)
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1
PGIMER
Chandigarh, Chandigarh, India, 160012