| CTRI Number |
CTRI/2018/08/015179 [Registered on: 03/08/2018] Trial Registered Prospectively |
| Last Modified On: |
31/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Vitamin D status of children suffering from nutritional Rickets after treatment. |
|
Scientific Title of Study
|
Effect of weekly supplementation of oral 2000IU v/s 4000IU vitamin D3 on 25(OH)D levels,12 weeks after administration of oral 3 lakhs IU vitamin D3 in nutritional rickets.A randomized double blind study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KAMRAN AHMAD |
| Designation |
Junior Resident 1,Department of Pediatrics |
| Affiliation |
Eras Lucknow Medical College and Hospital,Lucknow |
| Address |
Department Of Pediatrics
Eras Lucknow Medical College and Hospital,
Sarfarazganj,Hardoi road
Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8755482605 |
| Fax |
|
| Email |
kahmad.786@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrProf MMA Faridi |
| Designation |
Principal,Dean & Professor of Pediatrics |
| Affiliation |
Eras Lucknow Medical College and Hospital,Lucknow |
| Address |
Eras Lucknow Medical College and Hospital,
Sarfarazganj,Hardoi road
Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7317794765 |
| Fax |
|
| Email |
mmafaridi@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
KAMRAN AHMAD |
| Designation |
Junior Resident 1,Department of Pediatrics |
| Affiliation |
Eras Lucknow Medical College and Hospital,Lucknow |
| Address |
Department Of Pediatrics
Eras Lucknow Medical College and Hospital,
Sarfarazganj,Hardoi road
Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8755482605 |
| Fax |
|
| Email |
kahmad.786@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Research Grant from Eras Lucknow Medical College |
|
|
Primary Sponsor
|
| Name |
Eras Lucknow Medical College and Hospital |
| Address |
Eras Lucknow Medical College and Hospital
Sarfarazganj,Hardoi road
Lucknow-226003 |
| Type of Sponsor |
Private 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 |
| KAMRAN AHMAD |
Eras Lucknow Medical College and Hospital |
Department Of Pediatrics
Lucknow
UTTAR PRADESH |
8755482605
kahmad.786@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Eras Lucknow Medical College and Hospital,Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Nutritional Rickets, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
vitamin D3 |
2000IU,Weekly,Oral,12 Weeks |
| Comparator Agent |
Vitamin D3 |
4000IU,Weekly,Oral,12 Weeks |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children between the ages of 6months-5years presenting to pediatric OPD or emergency with a combination of clinical evidence and radiological findings consistent with the diagnosis of rickets. |
|
| ExclusionCriteria |
| Details |
Children having coexisting fat malabsorption,liver or renal insufficiancy and hypercalcemia.
Children with history of having received calcium supplements or other medications affecting vitamin D metabolism(eg-anticonvulsants,steroids,cancer chemotherapy) in previous 6months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum 25(OH)D levels more than 20ng/ml. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in clinical and radiological findings |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
16/08/2018 |
| 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="9"
Days="18" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized,double blind,parallel group study to see the effect of weekly supplementation of oral 2000 IU v/s 4000 IU vitamin D3 on 25(OH)D levels,12 weeks after administration of oral 3 lakhs IU vitamin D3 in nutritional rickets.The study will be conducted in Eras Lucknow Medical College and Hospital,Lucknow.The primary outcome will be serum 25(OH)D levels more than 20ng/ml after 12 weeks. |