| CTRI Number |
CTRI/2019/06/019543 [Registered on: 06/06/2019] Trial Registered Prospectively |
| Last Modified On: |
17/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Vitamin D supplement] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of 2 different doses of Vitamin D to improve bone strength in disease of progressive muscle weakness named DMD. |
|
Scientific Title of Study
|
Comparison of supplementation with two different doses of vitamin D on bone mineral density in patients with Duchenne muscular dystrophy- A randomised double blind 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 |
Dr Reena Gulati |
| Designation |
Additional Professor |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Pediatrics
JIPMER
Dhanvantri Nagar
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9443437740 |
| Fax |
|
| Email |
g97rina@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reena Gulati |
| Designation |
Additional Professor |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Pediatrics
JIPMER
Dhanvantri Nagar
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9443437740 |
| Fax |
|
| Email |
g97rina@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sasireka |
| Designation |
MD Pediatrics student |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Pediatrics
JIPMER
Dhanvantri Nagar
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
sasirekha.ssr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural fund from Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry |
|
|
Primary Sponsor
|
| Name |
Dr Reena Gulati |
| Address |
Department of Pediatrics
JIPMER
Pondicherry 605006 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Dr Reena Gulati |
JIPMER, Pondicherry |
Department of Pediatrics
JIPMER
Pondicherry 605006
Pondicherry
PONDICHERRY |
9443437740
g97rina@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| JIPMER I stitute Ethics Committee (Human studies) |
Approved |
| JIPMER Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G710||Muscular dystrophy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Supplementation with Vitamin D3 |
Oral Vit D3 1000 units/day for 6 months |
| Intervention |
Supplementation with Vitamin D3 |
Oral Vit D3 4000 units/day for 6 months |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Male |
| Details |
Patients with confirmed diagnosis of DMD with serum Vitamin D level < 75 nanomol/L |
|
| ExclusionCriteria |
| Details |
1. Patients with other forms of muscular dystrophy
2. Boys with joint contractures and/or severe kyphoscoliosis
3. Inability to stand upright |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bone mineral density |
0 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in 6 minute walk distance, time taken to rise from floor, change in Vignos functional scale grading |
0 months
6 months |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "14"
Final Enrollment numbers achieved (India)="14" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/06/2019 |
| Date of Study Completion (India) |
10/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients with DMD are prone to loss of bone mass, osteoporosis and fractures of long bones and vertebrae. There is some evidence that supplementation with Vitamin D improves the status of bone mineralisation in DMD patients, improves mobility and prevents fractures. Investigators have given different doses as indicated in the published literature, however, the optimum supplementary dose is not known. This study will be conducted to compare the bone mineral density and some clinical indicators of mobility after supplementation with 2 different doses of Vitamin D3 for a period of 6 months. We hypothesise that supplementation with the higher dose of 4000 units per day for 6 months will improve the outcome measures more than suppkementation with 1000 units per day for a period of 6 months.
|