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Study of outcome of Prednisolone with Vitamin B12 versus without steroids in the treatment of west syndrome

A Randomized Control Trial on the effectiveness of Prednisolone with Vitamin B12 and Prednisolone alone in the treatment of West Syndrome - PVB12WS

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/10/028214
Enrollment
110
Registered
2020-10-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G404- Other generalized epilepsy and epileptic syndromes

Interventions

Intervention1: Prednisolone with vitamin B12 is the Intervention.: Prednisolone 4mg/kg/day for 14 days followed by tapering over 3 months, Vitamin B12 1000mcg per day for 14 days followed by 1000mcg p

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.CHILDREN PRESENTING WITH INFANTILE SPASMS 2.INTERICTAL EEG SHOWING HYPSARRHYTHMIA 3.WITH OR WITHOUT DEVELOPMENTAL DELAY

Exclusion criteria

Exclusion criteria: 1.CHILDREN WITH WEST SYNDROME SECONDARY TO TUBEROUS SCLEROSIS,BIOTIN DEFICIENCY , PYRIDOXINE DEFICIENCY 2.CHILDREN IN WHOM STEROIDS ARE CONTRAINDICATED LIKE INFECTIONS AND HYPERTENSION 3.WHO HAVE ALREADY RECEIVED TREATMENT WITH ACTH AND OTHER STEROIDS

Design outcomes

Primary

MeasureTime frame
1.CESSATION OF SPASMS 2.NO RESPONSE:50% CESSATION 3.PARTIAL RESPONSE :50-100%CESSATION 4.COMPLETE RESPONSE :100%CESSATIONTimepoint: 2 WEEKS—

Secondary

MeasureTime frame
1.RESOLUTION OF EEG ABNORMALITY 2.RELAPSE RATES OF SPASMS 3.SIDE EFFECTS:WEIGHT GAIN, HYPERTENSION ,INFECTIONS, GASTRITISTimepoint: 6 MONTHS—

Countries

India

Contacts

Public ContactDeepthi B

Indira Gandhi Institute of Child Health

drknvraju08@gmail.com9535212556

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026