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CTRI Number  CTRI/2019/03/018278 [Registered on: 26/03/2019] Trial Registered Prospectively
Last Modified On: 25/08/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective Survey 
Study Design  Other 
Public Title of Study   To study the levels of Vitamin K2-7 in healthy subjects 
Scientific Title of Study   A prospective survey of plasma levels of vitamin K2-7 (MK-7) in healthy volunteers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dilip Mehta 
Designation  CEO 
Affiliation  Synergia Life Sciences Pvt Ltd 
Address  6/312, Jogani Industrial Complex, V N Purav Marg, Chunabhatti

Mumbai
MAHARASHTRA
400022
India 
Phone    
Fax    
Email  dilipmehta799@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yogesh Dound 
Designation  Medical Director 
Affiliation  Synergia Life Sciences Pvt Ltd 
Address  6/312, Jogani Industrial Complex, V N Purav Marg, Chunabhatti

Mumbai
MAHARASHTRA
400022
India 
Phone  022-24055607  
Fax    
Email  yogesh_dound@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Shashank Jadhav 
Designation  Medical Associate 
Affiliation  Synergia Life Sciences Pvt Ltd 
Address  6/312, Jogani Industrial Complex, V N Purav Marg, Chunabhatti

Mumbai
MAHARASHTRA
400022
India 
Phone  022-24055608  
Fax    
Email  shashankviridis@hotmail.com  
 
Source of Monetary or Material Support  
Synergia Life Sciences Pvt Ltd, 6/312, Jogani Industrial Complex, V.N. Purav Marg, Chunabhatti, Mumbai-400022 
 
Primary Sponsor  
Name  Synergia Life Sciences Pvt Ltd 
Address  6/312, Jogani Industrial Complex, V. N. Purav Marg, Chunabhatti, Mumbai – 400 022, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dilip Mehta  Kokan Hospital  Department of Medicine Areshwar Building, 1st Floor, Mhada Colony, Jogeshwari East, Mumbai 400060
Mumbai
MAHARASHTRA 		 022-24055608

dilipmehta799@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Intersystem BioMedica Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  28.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Male and female aged 28 to 45 healthy subjects.
Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in kg / height in sq.m.
Willing to give informed consent. 
 
ExclusionCriteria 
Details  People who are suffering from any systemic illness.
People who are on corticosteroids and oral contraceptives.
People on antibiotics within last week
People with seropositive status.
Pregnancy and lactating women
Participation in clinical trials evaluating investigational pharmaceuticals or biologics within 3 months or devices within 30 days of admission to the study.
People who are on coumarin analogues or Quinine Hydrochloride.
People who have history of smoking, history of alcohol. substance abuse, within last week. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
The primary objective is to study the levels of Vitamin K2-7 in healthy volunteers  1 day 
 
Secondary Outcome  
Outcome  TimePoints 
Vitamin K2-7 levels  1 day 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   26/03/2019 
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="0"
Months="0"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  		 NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

After subjects meet the eligibility criteria an informed consent form (ICF) will be signed before inclusion into the trial. The subjects will undergo besides a detailed history and complete physical examination.

For the blood tests 20 cc of blood will be collected in fasting state. A detailed medical history will be taken at the time of screening. Clinical Examination of each subject will be done and recorded in the Case Record Form (CRF).

The samples will be centrifuged at 3000 rcf for 5 minutes below 10°C to separate plasma. For precaution purpose, the blood samples will be kept in ice cold water bath before centrifugation and during separation. The separated plasma will be transferred to pre-labeled polypropylene tubes and stored upright in a box containing dry ice or in a freezer at a temperature -65 ± 10 °C for interim storage as required.

Finally the samples will be transferred by keeping them in a box containing dry ice and stored in a bioanalytical freezer at -65 ± 10 °C until completion of analysis at Synergia Life Sciences Pvt. Ltd.

The concentration of vitamin K2-7 will be measured at Synergia Life Sciences Pvt. Ltd. using single Fluorescence HPLC method, which is validated according to the international guidelines. Literature data of vitamin K2-7 will be used for comparison in view of complete paucity of Indian data on plasma levels of Vitamin K2-7.

 
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