| CTRI Number |
CTRI/2026/03/105384 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Screening |
| Study Design |
Other |
|
Public Title of Study
|
A study of co-relation of Vitamin D levels and comorbidities in children with sickle cell disease. |
|
Scientific Title of Study
|
A study of co-relation of Vitamin D levels and comorbidities in children with sickle cell disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aishwarya Mohan Mahadik |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept of Pediatrics, 2nd Floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
7506726136 |
| Fax |
|
| Email |
amahadik21097@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R J Meshram |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept of Pediatrics, 2nd Floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9823763989 |
| Fax |
|
| Email |
rjmeshram@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R J Meshram |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept of Pediatrics, 2nd Floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9823763989 |
| Fax |
|
| Email |
rjmeshram@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research, |
| Address |
Sawangi Meghe, Wardha, India 442001 |
| 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 |
| Aishwarya Mahadik |
Acharya Vinoba Bhave Rural Hospital |
Department of Paediatric,2nd floor,A block Sawangi Meghe
Wardha
MAHARASHTRA |
7506726136
amahadik21097@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research, Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D570||Hb-SS disease with crisis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
laboratory evaluation |
Vitamin D levels will be compared.
Deficient less than 20ng/ml
Insufficient 20-29 ng/ml
Sufficient greater than 30 ng/ml
|
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Confirmed diagnosed case of sickle cell disease(HbSS) |
|
| ExclusionCriteria |
| Details |
Patients without consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vitamin D levels to relieve pain,enhance efficiency and reduce the development of anaemia |
Assessment will be done 24 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
01/04/2026 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
The national prevalence of Vitamin D deficiency (<20 mg/dl) in all children is 14%.Children with sickle cell disease are 53 times more likely to develop Vitamin D deficiency than healthy children.It is estimated that 65% of children with sickle cell disease had severe Vitamin D deficiency possibly due to increased skin pigmentation and reduced exposure to sunlight.we tested the hypothesis that low levels of Vitamin D would be associated wit co-morbidities in sickle cell disease. Sickle cell disease is a hereditary blood disorder characterized by chronic hemolysis,vaso-occlusive crisis and organ damage. Recent studies suggest that there is high prevalence of Vitamin D deficiency due to chronic inflammation,renal impairment,poor nutrition.Vitamin D plays a vital role in immune modulation and bone healthits deficiency may exacerbate complication in sickle cell disease. This study aims to understand this co-relation could guide preventive and therapeutic strategies to improve patient outcome. |