| CTRI Number |
CTRI/2023/09/057212 [Registered on: 01/09/2023] Trial Registered Prospectively |
| Last Modified On: |
29/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A comparative Clinical study to assess the bioavailability of FIL-Vitamin C formulation in healthy volunteers. |
|
Scientific Title of Study
|
A randomized, single-dose, double-blind, active-controlled, two-way crossover study to assess the oral bioavailability of FIL-Vitamin C in healthy volunteers. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-VH-117 Version No 1.0 dated 27 Jun 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harshith CS |
| Designation |
Assistant Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
Department of General Medicine,
No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9741073960 |
| Fax |
|
| Email |
drharshithcs.research@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research #9,Mythri Legacy, 202 1st Floor,Chelekere Kalyan Nagar (PO)
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestinleadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research #9,Mythri Legacy, 202 1st Floor,Chelekere Kalyan Nagar (PO)
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestinleadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vidya Herbs Pvt Ltd,Vidya Building, N3-3,24th main road, 1st Phase, JP Nagar Bengaluru, Karnataka - 560078,India |
|
|
Primary Sponsor
|
| Name |
Vidya Herbs Pvt Ltd |
| Address |
Vidya Building, N3-3,24th main road, 1st Phase, JP Nagar Bengaluru, Karnataka - 560078,India |
| Type of Sponsor |
Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] |
|
|
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 Harshith CS |
BGS Global Institute of Medical Sciences |
Department of General Medicine, Ground Floor, BGS Global Institute of Medical Sciences, No.67, BGS Health and Education City, Uttarahalli Main Road, Kengeri
Bangalore
KARNATAKA |
9741073960
drharshithcs.research@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, BGS Global Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
With Normal Hematological and Biochemical Parameters |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FIL-Vitamin C |
Oral administration of single dose of formulated Vitamin C 600mg capsule |
| Comparator Agent |
Unformulated Vitamin C |
Oral administration of single dose of unformulated Vitamin C 600mg capsule |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with Body mass index (BMI) of 18-25 kg/m2.
2.Subjects who are willing to give their written informed consent to participate in the study and comply with the protocol requirements.
3.Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening.
|
|
| ExclusionCriteria |
| Details |
1.Subjects who have consumed Vitamin C containing food 2 days prior to screening.
2.History of consumption medications known to interact with Vitamin C.
3.Subjects having symptoms of viral infection.
4.Pregnant or lactating women.
5. History of
•Irritable bowel syndrome, malabsorption or gastrointestinal abnormalities which may affect drug absorption, duodenal ulcer or gastric ulcer, gastritis.
•Kidney disease, kidney stones, cardiac conditions.
•Recent blood donation (within 1 month).
•Current smoker or has quit smoking within last 3 months.
•Alcoholism and/or drug abuse, or heavy drinkers.
•Immunodeficiency disease.
•Allergy, medication or supplement use that influences the immune system.
6.Subjects with known hypersensitivity to the investigational products.
7.Subjects who have participated in any clinical trial in the past 1 month.
8.Any subjects found to have entered the study in violation of this protocol or if the subject is uncooperative during the study.
9.Any other condition that in the opinion of the investigator that does not justify the subject’s participation in the trial. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the plasma concentrations of Vitamin C following supplementation of FIL-Vitamin C and/or unformulated Vitamin C, in healthy volunteers. |
Pre-dose sample, Post-dose sample at 30 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8hours & 12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The safety & tolerability of FIL-Vitamin C Formulations
|
Pre-dose sample, Post-dose sample at 30 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8hours & 12 hours |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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 4 |
|
Date of First Enrollment (India)
|
09/09/2023 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized, single-dose, double-blind, active-control comparative, two-way crossover, 2-sequence study to assess the comparative oral bioavailability of FIL-Vitamin C and unformulated Vitamin C supplementation in healthy volunteers. A group of 12 healthy volunteers willing to give a written informed consent will be screened on Visit 1 to confirm the eligibility. Subjects fulfilling the eligibility criteria will be randomized into 1 of 2-treatment sequences on Visit 2. The 2-treatment sequences are: Sequence 1: Treatment A and B; Sequence 2: Treatment B and A. There will be a wash out period of 7 days between 2 dosing days, |