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

NCT02762682 | Completed

• 1 other identifier: Its12pgi
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant Nutrition Disorder

Outcome Measures

Primary Outcomes (1)

• vitamin b12 status in children with ITS and preITS

  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.

  July 2015 to December 2016

Secondary Outcomes (1)

• vitamin B12 Status in mothers of children with ITS and preITS folate status in these children and their mothers

  July 2015 to December 2016

Study Arms (2)

CASES OF ITS AND PRE ITS

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

HEALTHY CONTROLS

Developmentally normal child not suffering from any acute or chronic neurological illness

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Hospital based study (Advanced Pediatrics Centre, PGIMER) all cases of infantile tremor syndrome (ITS) and pre ITS presenting to APC during the study period

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

PGIMER

Chandigarh, Chandigarh, 160012, India

Location

Related Publications (1)

• Chaudhary H, Verma S, Bhatia P, Vaidya PC, Singhi P, Sankhyan N. Infantile Tremor Syndrome or a Neurocutaneous Infantile B12 Deficiency (NIB) Syndrome? Indian J Pediatr. 2020 Mar;87(3):179-184. doi: 10.1007/s12098-019-03117-w. Epub 2020 Jan 27.

  PMID: 31984470 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples

MeSH Terms

Conditions

Infant Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Dr Naveen Sankhyan, MBBS,MD,DM

  PGIMER Chandigarh

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior resident

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 5, 2016
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 28, 2016

Record last verified: 2016-12

Locations

IN (1)