| CTRI Number |
CTRI/2022/12/048410 [Registered on: 22/12/2022] Trial Registered Prospectively |
| Last Modified On: |
14/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to see Levels of Vitamin MK-7 in blood of Healthy Subjects |
|
Scientific Title of Study
|
A Prospective study to assess serum levels of Vitamin MK-7 in Healthy Subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BCR-SYN-004, Version 1.0 Dated 09-Nov-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pravin Soni |
| Designation |
Principal Investigator |
| Affiliation |
PCMCs PGI Yashwantrao Chavan Memorial Hospita |
| Address |
Room no 03, 2nd floor, Department of Medicine YCM Hospital Rd, Sant Tukaram Nagar, Pimpri Colony, Pune, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9822057511 |
| Fax |
|
| Email |
drpravinsoni18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt.Ltd |
| Address |
Office No. 02, 03 & 04, Second Floor, Highland Corporate
Center,Kapurbawdi Junction, Thane (W),Maharashtra
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashank S Jadhav |
| Designation |
Medical Director |
| Affiliation |
Synergia Life Sciences Pvt. Ltd. - A Novozymes One Health Company |
| Address |
1503,Universal Majestic, PL Lokhande Marg, Chembur, Mumbai,
Maharashtra 400071, India
Mumbai
Mumbai
MAHARASHTRA
400071
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
SSAJ@novozymes.com |
|
|
Source of Monetary or Material Support
|
| Synergia Life Sciences Pvt. Ltd. - A Novozymes One Health Company
1503, Universal Majestic, P. L. Lokhande Marg,
Ghatkopar - Mankhurd Link Road,Govandi,
Mumbai - 400 043 |
|
|
Primary Sponsor
|
| Name |
Synergia Life Sciences Pvt. Ltd. - A Novozymes One Health Company |
| Address |
1503, Universal Majestic, P. L. Lokhande Marg, Ghatkopar - Mankhurd Link Road,Govandi, Mumbai - 400 043 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manish Kumar Singh |
Asian Multispeciality Hospital |
Department of Medicine, Baghpur, Dehat-209307, Kanpur, UP, India
Kanpur Dehat
UTTAR PRADESH |
7007592197
drmanishkumar820@gmail.com |
| Dr Sanjay Vaze |
Bio-Orbit Research Pvt. Ltd |
Storewell Warehousing corporation,GAT NO 2347/B/01 Pune Nagar Road, Wagholi, Pune-412207
Pune
MAHARASHTRA |
9322344635
sanjay.vaze@bio-orbit.com |
| Dr SSVV Narsinga Rao |
Government Medical College & Government General hospital (old RIMSGGH) Srikakulam |
Department of Medicine,Srikakulam, Andhra Pradesh-532001, India.
Srikakulam
ANDHRA PRADESH |
9908611119
drnarasingaraossvv@yahoo.com |
| Dr Madhumati Varma |
Jaipur National University Institute for Medical Sciences and Research Centre |
Department of General Medicine, Near New RTO Office, Agra Road, Jagatpura, Jaipur-302017, Rajasthan, India.
Jaipur
RAJASTHAN |
9784642270
advisoroffice@jnujaipur.ac.in |
| Dr Bharath M S |
Mysore medical college and research institute and associated hospitals |
Department of General Medicine,K.R.Hospital, Irwin Road, Mysore-570001, Karnataka, India
Mysore
KARNATAKA |
8971241203
bharathms7@yahoo.com |
| Dr Pravin Soni |
PCMCs PGI Yashwantrao Chavan Memorial Hospital |
Room no 03 2nd floor
Department of Medicine
YCM Hospital Rd, Sant
Tukaram Nagar, Pimpri
Colony, Pune,
Maharashtra 411018
Pune
MAHARASHTRA |
9822057511
drpravinsoni18@gmail.com |
| Dr Rimita Dey |
Ruby general hospital |
Department of Critical care,, 576 Anandapur, EM Bypass, Sector I, Kasba, Golpark, Kolkata, West Bengal 700107, India
Kolkata
WEST BENGAL |
9836896638
rimitadey1506@gmail.com |
| Dr Ashish H Sarwate |
Shivam Polyclinic |
2nd Floor Pradhan Building, Above Mango Showroom, Gokhale
Road, Naupada, Thane- west
Thane
MAHARASHTRA |
9324508128
ashish.sarwate@gmail.com |
| Dr Neeraj Gupta |
W Pratiksha Hospital |
Department of Respiratory Medicine,Golf Course Ext Rd, Sushant Lok 2, Sector 56, Gurugram, Haryana -122011, India
Gurgaon
HARYANA |
8826890151
neeraj.gupta@w-hospital.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Ethics Committee Brij Medical Centre Kanpur |
Approved |
| Institutional Ethics Committee JNU Institute for Medical Sciences and Research Centre |
Approved |
| Institutional Ethics Committee PCMC’s PGI Yashwantrao Chavan Memorial Hospital |
Approved |
| Institutional Ethics Committee, Government Medical College & Government General Hospital |
Approved |
| Institutional Ethics Committee, Mysore Medical College & Research Institute and Associated Hospitals |
Approved |
| Institutional Ethics Committee, Ruby General Hospital |
Approved |
| North East Healthcare Pvt. Ltd |
Submittted/Under Review |
| Royal Pune Independent Ethics |
Approved |
| V Care Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
To assess serum levels of Vitamin MK-7 in Healthy Subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy Male or Female subjects between 18 to 65 years of age (Both Inclusive).
2. Subjects with Normal physical examination at screening visit,
3. Subjects with Normal/ acceptable 12-lead electrocardiographic results at least after 5 minutes of rest at screening
4. Subjects with Laboratory results within normal range or clinically non-significant (CBC, total bilirubin, SGOT, SGPT ,S.Creatinine and urinalysis),
5. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures. |
|
| ExclusionCriteria |
| Details |
1. Subjects with any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major diagnosed disease or malignancy.
2. Presence or history of any gastrointestinal surgery except appendectomy or except herniotomy.
3. Subjects Having the Body Mass Index ranged between 18.5-24.9 kg/m2.
4. Subjects suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator’s judgement.
5. Subjects using of vitamin K-containing multivitamins or vitamin K supplements within 21 days prior to screening.
6. Subjects who are on antibiotics or had antibiotic treatment 4 weeks prior to screening visit
7. History of drug and alcohol abuse.
8. Subjects with history of HIV or hepatitis B or hepatitis C at screening visit.
9. Female subjects who are pregnant or lactating. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the serum levels of Vitamin MK-7 in healthy subjects. |
Day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the gene expression of MK-7 related markers in serum. |
Day 1 |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
29/12/2022 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a Prospective study to assess serum levels of Vitamin MK-7 in Healthy Subjects
The primary objective of the study is to assess the serum levels of Vitamin MK-7 in healthy subjects and secondary objective of the study is to assess the gene expression level of MK-7 related markers in serum.
Primary Endpoint is to assess the serum levels of Vitamin MK-7 in healthy subjects
Secondary Endpoint is to assess the gene expression of MK-7 related markers in serum. |