| CTRI Number |
CTRI/2025/05/086944 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
03/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
“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. |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankaj sharma |
| Designation |
DM senior resident |
| Affiliation |
Aiims New Delhi |
| Address |
MCB / 5C Aiims New Delhi
Division of pediatric endocrinology
Department of pediatrics
AIIMS NEW DELHI
West
DELHI
110029
India |
| Phone |
8988093284 |
| Fax |
|
| Email |
sharmaankaj511@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajni Sharma |
| Designation |
Additional professor |
| Affiliation |
Aiims New Delhi |
| Address |
Room no -830 8th floor MCB
Divsion of pediatric endocrinology
Department of pediatrics
AIIMS NEW DELHI
West
DELHI
110029
India |
| Phone |
9811334144 |
| Fax |
|
| Email |
drrajnisharma@yahoo.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Ankaj sharma |
| Designation |
Senior Resident |
| Affiliation |
Aiims New Delhi |
| Address |
Room no 830
Division of pediatric endocrinology
Department of pediatrics
AIIMS NEW DELHI
West
DELHI
110029
India |
| Phone |
8988093284 |
| Fax |
|
| Email |
sharmaankaj511@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pulse pharmaceutical pvt ltd
Phae 2 Mayapuri New Delhi
110064 |
|
|
Primary Sponsor
|
| Name |
Pulse pharmaceutical pvt ltd |
| Address |
Phase 2, Maya Puri, E-90, Mayapuri Industrial Area Phase II, Mayapuri, New, Division, New, Delhi, 110064 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankaj Sharma |
AIIMS NEW DELHI |
Division of pediatric endocrinology
Department of Pediatrics Aiims New delhi
West
DELHI |
8988093284
sharmaankaj511@gmail.com |
| Dr Sanjeevani kaul |
ILBS DELHI |
PEDIATRIC GASTROENTEROLOGY WARD ILBS DELHI
South
DELHI |
9003938057
sanjeevani.kaul07@gmail.com |
| Dr Shyam K Meena |
VMMC SAFDARJUNG |
Pediatric gastroenterology OPD VMMC SAFDARJUNG
South
DELHI |
9013677438
dr.shyamsnmc2000@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS New Delhi Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K77||Liver disorders in diseases classified elsewhere, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
oral vitamin D3 Sachet and Oral vitamin D3 Syrup |
For age less than one year we will give oral vitamin D3 syrup and age more than we will give oral sachet once in every 2 weeks for total duration of 12 weeks. |
| Intervention |
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.
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
3.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 3 months to 18 years with diagnosis of
Cholestasis having conjugated hyperbillirubinemia >
3 months. |
|
| ExclusionCriteria |
| Details |
vit d3 more than 20ng/ml.
|
|
Method of Generating Random Sequence
Modification(s)
|
Stratified block randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 cholestasis |
6 and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check prevlance of rickets in pediatric cholestasis |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Children aged between 3 months to18 years with a diagnosis of cholestasis who meet the inclusion criteria will be enrolled from the Pediatric OPD and ward after a baseline clinical and biochemical assessment. Participants will then be randomly allocated into two groups using stratified block randomization. One group will receive oral sachets (one sachet every two weeks) if age more than one year and (oral syrup) if age less than 1 year while the other group will receive a daily buccal spray (1 spray = 1000 IU) for a total duration of 3 months. A second assessment including biochemical investigations, will be conducted at 6 weeks followed by a third assessment at 12 weeks. The mean difference in vitamin D levels between the two groups will be compared at the end of the study. |