| CTRI Number |
CTRI/2019/09/021029 [Registered on: 02/09/2019] Trial Registered Prospectively |
| Last Modified On: |
28/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Usefulness of Vitamin D Supplements and its Receptor Genetic variations in sugar patients with Infection of Foot from Southern part of India |
|
Scientific Title of Study
|
Effect of Vitamin D Supplementation and Vitamin D Receptor Gene Polymorphisms in South-Indian Patients with Diabetic Foot Infection |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shilia Jacob Kurian |
| Designation |
Ph.D. research scholar |
| Affiliation |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice
room no 13
kasturba hospital
manipal udupi
Manipal Academy of Higher Education,
Manipal, Udupi- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9886078058 |
| Fax |
|
| Email |
shilia.kurian@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Sekhar M |
| Designation |
Assistant Professor (Selection Grade) |
| Affiliation |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice
room no 3
kasturba hospital
manipal udupi
Manipal Academy of Higher Education,
Manipal, Udupi-576104
Udupi
KARNATAKA
576104
India |
| Phone |
7411338846 |
| Fax |
|
| Email |
sonal.sekhar@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Shilia Jacob Kurian |
| Designation |
Ph.D. research scholar |
| Affiliation |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice
room no 13
kasturba hospital
manipal udupi
Manipal Academy of Higher Education,
Manipal, Udupi-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9886078058 |
| Fax |
|
| Email |
shilia.kurian@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and hospital, Manipal Academy of Higher education
Manipal, Udupi, Karnataka-576104 |
|
|
Primary Sponsor
|
| Name |
Manipal Center for Infectious Diseases |
| Address |
Manipal Center for Infectious Diseases
room no 5
faculty rooms
near KMC administrative office
manipal 576104 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Shilia Jacob Kurian |
Kasturba hospital |
Room no: 13, Department of Pharmacy Practice, Kasturba Hospital, Manipal Academy of Higher Education, Madhav nagar
manipal Udupi 576104
Udupi
KARNATAKA |
09886078058
shilia.kurian@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kasturba medical college and kasturba hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy participants without a previous history of diabetes |
| Patients |
(1) ICD-10 Condition: E106||Type 1 diabetes mellitus with other specified complications, (2) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Both genders
2. Age 18 years or older
3. Patients with type 1 or 2 DM
4. Newly diagnosed foot ulcers
5. IDSA: uninfected. (For DFU patients)
6. IDSA: mild/moderate (For DFI patients)
7. Volunteers without a previous history of DM who has come for regular health check-up or blood donation (healthy controls)
8. Participants willing to give the informed consent form and participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Individuals with hepatic disease, renal disease, or other comorbidities that can alter vitamin D levels
2. Diagnosis of lower limb critical ischemia by Doppler ultrasound and ankle/arm index less than 0.5
3. Patients with lower limb ulcers with distal necrosis
4. Patients having clinical evidence of vascular insufï¬ciency
5. Patients currently on steroid (use in the past 30 days) cytotoxic drugs, immunosuppressants, Calcium supplements, multivitamins, and drugs that could alter vitamin D status
6. Pregnant or breastfeeding women
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
Clinical Wound Healing
Health Related Quality of Life (HRQoL) |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
4 months |
|
|
Target Sample Size
|
Total Sample Size="476"
Sample Size from India="476"
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)
|
05/09/2019 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A prospective cohort study will be conducted to investigate the role of vitamin D in patients with diabetic foot infection (DFI) among South-Indian population. To study the association between vitamin D status and development of foot infection in DFU patients, 80 patients with diabetic foot ulcers (DFU) will be followed up for 4 months to observe the outcome. And to determine the effect of Vitamin D supplementation in clinical and biochemical outcomes; and Quality of life (QoL) among DFI patients, 196 DFI patients will be followed for 4 months. They will be categorized into reference group (RG) and study group (SG). RG patients will not be on vitamin D supplements and SG patients will receive vitamin D supplements. A cross-sectional study will be conducted among 50 subjects each from 4 groups [DFI, DFU (without infection), diabetes patients (without ulcer) and healthy controls] to elucidate VDR gene polymorphisms. The four VDR SNPs: BsmI (SNP ID: rs1544410), ApaI (SNP ID: rs7975232), TaqI (SNP ID: rs731236) and FokI (SNP ID: rs2228570) will be genotyped using TaqMan SNP genotyping assay by a real-time polymerase chain reaction (PCR). |