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CTRI Number  CTRI/2013/06/003770 [Registered on: 19/06/2013] Trial Registered Retrospectively
Last Modified On: 22/02/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Clinical Study For Studying the Absorption of Vitamin D3 Oral Spray in comparison with Vitamin D3 Capsule In Healthy and Unhealthy Subjects Under Fed Conditions After One Month Dose Administrations. 
Scientific Title of Study   A Randomized, Open-label, Balanced, Two-period, Two-treatment, Two way Cross-over Study For Studying the Absorption of Test Product: D-LIGHT™ (Vitamin D3 Oral Spray) in comparison with Reference Product: Uprise-D3 (Vitamin D3 Capsule 1000 IU) In Healthy and Unhealthy Subjects Under Fed Conditions After One Month Dose Administrations. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ECTS/13/003, Version No 01 Dated 13 APR 2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Milan Satia 
Designation  Chief Executive Officer 
Affiliation  Ethicare Clinical Trial Services 
Address  5/C, Vardan Tower, Nr. Vimal House, Vithalbhai Patel Colony, Navrangpura

Ahmadabad
GUJARAT
380014
India 
Phone  09825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Milan Satia 
Designation  Chief Executive Officer 
Affiliation  Ethicare Clinical Trial Services 
Address  5/C, Vardan Tower, Nr. Vimal House, Vithalbhai Patel Colony, Navrangpura


GUJARAT
380014
India 
Phone  09825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Details of Contact Person
Public Query
 
Name  Dr Milan Satia 
Designation  Chief Executive Officer 
Affiliation  Ethicare Clinical Trial Services 
Address  5/C, Vardan Tower, Nr. Vimal House, Vithalbhai Patel Colony, Navrangpura


GUJARAT
380014
India 
Phone  09825585119  
Fax    
Email  milansatia@ethicare-cro.com  
 
Source of Monetary or Material Support  
Pharma Base S.A. 
 
Primary Sponsor  
Name  Pharma Base SA 
Address  Pharma Base S.A. Schwerzistrasse 6, CH-8807 Freienbach, Switzerland 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akhil Mukim  ALL WELL  Mukim Medical Nursing Home & Heart Clinic, Room No 235, 2nd floor, Platinum Plaza, Judges Bunglow Road, Vastrapur, Ahmedabad – 380015, Gujarat, India
Ahmadabad
GUJARAT 
9825074444

drmukim@indiatimes.com 
Dr K D Tibrewala  Dr K D Tibrewala Clinic  A-61, 62; 6th Floor, Pariseema, Opp. Lal Bungalow, C.G. Road, Ahmedabad – 380006
Ahmadabad
GUJARAT 
07922866311

kdtibrewala@hotmail.com 
Dr Mahendra Bhavsar  Dr Mahendra Bhavsar Clinic  Room No 11, 2nd Floor, Vishvamitra Complex, Nr. Sardar Patel Colony, Stadium Road,Ahmedabad – 380014
Ahmadabad
GUJARAT 
09824043226

drmsbhavsar@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Spandan Independent Ethics Committee , Ahmedabad for Dr K D Tibrewala  Approved 
Spandan Independent Ethics Committee, Ahmedabad for Dr Akhil Mukim  Approved 
Spandan Independent Ethics Committee, Ahmeddabad for Dr Mahedra Bhavasar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  To evaluate absorption of test and reference product in healthy and unhealthy subjects of Test Product: D-LIGHT™ (Vitamin D3 Oral Spray) in comparison with Reference Product: Uprise-D3 (Vitamin D3 Capsule 1000 IU) In Healthy and Unhealthy Subjects After One Month Dose Administrations.  
Patients  Malabsorption disease: (Ulcerative Colitis and Steatorrhoea) in Healthy and Unhealthy subjects.,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  D-LIGHT™  Vitamin D3 Oral Spray, Dose: 1000 IU, Frequency: 2 spray/day (500IU/spray), Route of administration: Oral, Total Duration: 1 month 
Comparator Agent  Uprise-D3  Vitamin D3 Capsule, Dose: 1000 IU, Frequency: 1 Capsule/day, Route of Administration: Oral, Total Duration: 1 month 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Written informed consent for participation in the study by the subject.
2.Subjects of either sex, between 18 and 65 years of age (both inclusive).
3.Having a Body Mass Index (BMI) between 18.0 and 30.0 (kg/m2).
4.Able to comply with study procedures in the opinion of the investigator.
5.For healthy subjects:
5.1Not having any significant diseases or clinically significant abnormal findings during medical history, physical examination, laboratory evaluations etc.
5.2Subject having no any history of significant smoking habit (more than 10 cigarettes or beedi (Indian cigarette)’s/day).
6.For unhealthy subjects:
6.1Subjects with confirmed diagnosis of any one of the following Malabsorption disease condition:
•Ulcerative Colitis
•Steatorrhoea 
 
ExclusionCriteria 
Details  1.Subjects who are already taking a vitamin D supplement regularly (once per week or more), or travelling to sunny areas or using a tanning bed during the previous 3 months.
2.Subjects with history of uncontrolled hypertension.
3.Seated blood pressure less than 110/70 mmHg or pulse rate less than 60 or more than 100 beats per minute at screening.
4.Subjects with history of hypercalcemia, hyperparathyroidism or osteomalacia.
5.History or presence of cancer.
6.Difficulty in swallowing solids like tablets or capsules.
7.Subjects with history of peptic ulcer disease, frequent dyspepsia or bleeding.
8.Subjects with moderate or severe cognitive impairment.
9.No history of any medical condition or addictive disorder or laboratory abnormality that may increase the risks associated with disease condition in unhealthy subjects.
10.Positive screening test for any one or more: HIV I & II and Hepatitis B.
11.Any food allergy, intolerance, restriction or special diet that, in the opinion of the investigator could contraindicate the subject’s participation in this study.
12.Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.
13.Female subject who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period or breast feeding. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Absorption of test and reference product in healthy and unhealthy subjects.  90 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Safety, Tolerability and Compliance of test and reference product  90 Days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 3 
Date of First Enrollment (India)   23/05/2013 
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)  Open to Recruitment 
Publication Details    
Brief Summary  

To evaluate absorption of test and reference product in healthy and unhealthy subjects of Test Product: D-LIGHT™ (Vitamin D3 Oral Spray) in comparison with Reference Product: Uprise-D3 (Vitamin D3 Capsule 1000 IU) In Healthy and Unhealthy Subjects Under Fed Conditions After One Month Dose Administrations. Eligible patients with balanced male-female will be randomised in 1:1 ratio of test and reference product to receive the study treatment of Vitamin D3 Oral spray 500IU  two times or Vitamin D3 Capsule 1000IU half an hour after heavy meal in healthy and unhealthy subject for 1 month. After the washout period of one month, subjects will receive treatment in cross over fashion and treatment will be changed from test to reference and vice versa.  Vitamin D3 level is measured in healthy and unhealthy subjects on the day of 1st dose and at the end of study period - I,same procedure will be apply for period-II. Safety will also be evaluated based on measurements of hematology (CBC), biochemical parameters (serum creatinine, total bilirubin, urea, SGPT, SGOT, alkaline phosphatase, calcium) and urinalysis.

 
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