| CTRI Number |
CTRI/2025/09/094013 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
31/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of High-Dose Vitamin D on Calcium in Urine of Children Under 5 with Rickets" |
|
Scientific Title of Study
|
Urinary calcium excretion after depot oral cholecalciferol in under five children with nutritional rickets. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muskan Verma |
| Designation |
Post Graduate |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Paediatrics Maulana Azad Medical College and associated Lok Nayak Hospital New
Central
DELHI
110002
India |
| Phone |
9310414050 |
| Fax |
|
| Email |
muskanverma.v@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aashima Dabas |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Paediatrics Maulana Azad Medical College and associated Lok Nayak Hospital
Central
DELHI
110002
India |
| Phone |
9968604424 |
| Fax |
|
| Email |
dr.aashimagupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aashima Dabas |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Paediatrics Maulana Azad Medical College and associated Lok Nayak Hospital
Central
DELHI
110002
India |
| Phone |
9968604424 |
| Fax |
|
| Email |
dr.aashimagupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Paediatrics, Maulana Azad Medical College,2-Bahadur Shah Zafar Marg, New Delhi - 110002 |
|
|
Primary Sponsor
|
| Name |
Department of Paediatrics |
| Address |
Maulana Azad Medical College 2-Bahadur Shah Zafar Marg, New Delhi - 110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Muskan Verma |
Lok Nayak Hospital |
Pediatrics OPD Fifth Floor, OPD Building Maulana Azad Medical college and Associated Lok Nayak Hospital. New Delhi DELHI
Central
DELHI |
9310414050
muskanverma.v@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospitals(Lok Nayak, GB Pant Institute Post Graduate Medical Education (GIPMER) and Research hospital, Guru nanak Eye Centre, New Delhi-110002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E550||Rickets, active, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Depot Oral cholecalciferol |
Depot dose of 60000 IU oral cholecalciferol fortnightly (after every 2 weeks) for 5 doses in older children till 8 weeks and 3 doses fortnightly in infants till 4 weeks. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 3 to 59 months
Born at term more than equal to 37 weeks of gestation).
Clinical features of rickets (skeletal or extraskeletal) with serum 25 hydroxy vitamin D less than 20 ng/mL |
|
| ExclusionCriteria |
| Details |
Chronic Kidney Disease , tubulopathies, or known kidney disorders
Non Nutritional Rickets, such as rickets due to genetic disorders (e.g., hypophosphatemic rickets) or secondary to other metabolic conditions.
Any chronic Illness that may affect calcium or vitamin D metabolism, such as liver disease, malabsorption syndromes, or parathyroid disorders.
Use of Medications known to interfere with calcium or vitamin D metabolism (e.g., corticosteroids, anticonvulsants, glucocorticoids) in last three months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Mean Urinary calcium: creatinine excretion in children following depot dose of oral cholecalciferol |
At baseline and 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Association of urine calcium excretion with baseline serum calcium & 25 hydroxy vitamin D levels, dietary calcium intake, renal function
2 Resolution of hypercalciuria in children with raised urinary calcium
3To evaluate the effect of cumulative cholecalciferol doses on urine calcium
excretion. |
baseline 2 weeks & 12 weeks |
|
|
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)
|
11/09/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included muskanverma.v@gmail.com).
- For how long will this data be available start date provided 25-08-2026 and end date provided 25-08-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This study is a single arm interventional study aimed at finding Urinary Calcium Excretion after Depot Oral Cholecalciferol in Under Five Children with Nutritional Rickets. Study will be conducted in Paediatric OPD/ward at Maulana Azad Medical College and associated Lok Nayak Hospital, Delhi. Primary outcome is Change in Mean Urinary calcium: creatinine excretion in children following depot dose of oral cholecalciferol. Secondary outcome is Association of urine calcium excretion with baseline serum calcium and 25(OH)D levels, dietary calcium intake, renal function Resolution of hypercalciuria in children with raised urinary calcium Cumulative vitamin D doses and urine calcium excretion. |