Vitamin B-12 in Infantile Tremor Syndrome Study (BITS study)

Phase 3

• Conditions: Health Condition 1: null- Pre-Infantile Tremor Syndrome and Infantile Tremor Syndrome

• Registration Number: CTRI/2018/05/013841
• Lead Sponsor: PGIMER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Children aged 3month to 2 years of either sex meeting the criteria for Infantile Tremor Syndrome

2.Infantile Tremor Syndrome: Developmental delay or regression WITH history of exclusive or predominant breast feeding WITH two or more of the following; skin pigmentation, sparse or lightly pigmented hair, and/or tremors.

Exclusion Criteria

1.Parents not consenting

2.Patients requiring multinutrient therapy: (Severe anemia requiring blood transfusion, Severe acute malnutrition with complications, acute diarrhea, symptomatic hypocalcemia and vitamin D deficiency)

3.Severe illness requiring PICU admission/Mechanical ventilation

4.Children who have received oral or injectable vitamin B12 within 1 month prior to admission

5.Later confirmation of an alternative diagnosis

Study & Design

• Study Type: Interventional
• Study Design: Not specified