Clinical Trial: A Study of Vitamin B12 Status in Children With Infantile Tremor Syndrome and Pre Infantile Tremor Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Study of Vitamin B12 Status in Children With Infantile Tremor Syndrome and Pre Infantile Tremor Syndrome

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 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.

Detailed Summary:

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)

  1. Either sex, age less than 3 years
  2. 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)

  1. Parents refusing consent
  2. Later confirmation of an alternative diagnosis

  3. Patient has received oral or injectable Vitamin B12 in the past 6 months Controls (C)- Normally developing children

    • Inclusion criteria Developmentally normal child not suffering from any acute or chronic neurological illness
    • Exclusion criteria

1.Parent/individual refusing consent 2.Patient has received oral or injectable Vitamin B12 in the past 6 months

PLAN OF THE STUDY All consecutive patients who present in Pediatric Emergency and OPD in Advanced pediatric Centre with suspected Infantile tremor syndrome will be screened for inclusion in the study. Those found eligible would be included after an informed co
Sponsor: Postgraduate Institute of Medical Education and Research

Current Primary Outcome: vitamin b12 status in children with ITS and preITS [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: vitamin B12 Status in mothers of children with ITS and preITS folate status in these children and their mothers [ Time Frame: July 2015 to December 2016 ]

The blood levels of 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


Original Secondary Outcome: Same as current

Information By: Postgraduate Institute of Medical Education and Research

Dates:
Date Received: May 3, 2016
Date Started: July 2015
Date Completion:
Last Updated: December 27, 2016
Last Verified: December 2016