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“Effectiveness of a vitamin D spray compared to regular vitamin D drops in raising vitamin D levels in children with liver problems. participant- children with liver disease intervention- vitd3 buccal spray outcome- to compare improvement in vit d3 levels in both groups.

Efficacy of Nano-emulsified buccal mucosal spray of cholecalciferol vs Conventional cholecalciferol in achieving higher 25-hydroxy Vitamin D concentration in pediatric cholestasis- A randomised control trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/086944
Enrollment
40
Registered
2025-05-14
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: K77- Liver disorders in diseases classified elsewhere

Interventions

Intervention1: vit d3 nano emulsified buccal spray: Vit D3 buccal spray (1 spray contains 1000 IU) 4000 IU daily if age more than 1 year and 2000IU daily if age less than 1 year for 12 weeks. Control

Sponsors

Pulse pharmaceutical pvt ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients between 3 months to 18 years with diagnosis of Cholestasis having conjugated hyperbillirubinemia > 3 months.

Exclusion criteria

Exclusion criteria: vit d3 more than 20ng/ml.

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of Nano emulsified buccal mucosal spray of Cholecalciferol Versus Conventional Oral Cholecalciferol in achieving higher 25-Hydroxy Vitamin D Concentration in pediatric cholestasisTimepoint: 6 and 12 weeks—

Secondary

MeasureTime frame
To check prevlance of rickets in pediatric cholestasisTimepoint: at baseline—

Countries

India

Contacts

Public ContactAnkaj sharma

Aiims New Delhi

drrajnisharma@yahoo.com9811334144

Outcome results

None listed

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