| CTRI Number |
CTRI/2025/12/098688 [Registered on: 09/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study to compare how well DELT, Conventional and Plain Vitamin C are absorbed in healthy participants. |
|
Scientific Title of Study
|
A Randomized, Comparative, Single-Dose, Crossover, 3 Sequence Study to Assess the Bioavailability of Formulated Vitamin C (DELT) in Comparison with Liposomal and Reference Vitamin C Supplementations in Healthy Volunteers. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-BA-172, Version 1.0 dated 20 July 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayashree S Seeri |
| Designation |
Professor and HOD |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
Research Ward, 5th Floor, Hospital Building, No.67, BGS Health and Education City, Uttarahalli Road,Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
8792516793 |
| Fax |
|
| Email |
drjayashree.ct@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Managing Director and CEO |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Managing Director and CEO |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Encapscifi Life sciences Pvt.Ltd
Q2, Second cross, Dr. Ambedkar industrial estate, Jigani industrial area, Bangalore-560105, Karnataka |
|
|
Primary Sponsor
|
| Name |
Encapscifi Lifesciences Pvt. Ltd. |
| Address |
Q2, Second cross, Dr. Ambedkar industrial estate, Jigani industrial area, Bangalore-560105, Karnataka |
| 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 Jayashree S Seeri |
BGS Global Institute of Medical Sciences |
Research Ward, 5th Floor, Hospital Building, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA |
8792516793
drjayashree.ct@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 Biochemical and Hematological Parameters
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Vitamin C |
Oral administration of a single dose of Conventional Vitamin C capsule |
| Intervention |
DELT Vitamin C |
Oral administration of a single dose of DELT Vitamin C capsule |
| Comparator Agent |
Plain Vitamin C |
Oral administration of a single dose of Plain Vitamin C capsule |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject who agree not to consume any vitamin C based foods throughout the study. 2. Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening. 3. Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Subjects who have consumed either Vitamin C containing food/supplement 7 days prior to screening. 2.Pregnant or lactating women. 3.Subjects with known hypersensitivity to the investigational products. 4.Subjects who have participated in any clinical trial in the past 1 month. 5.Any subjects found to have entered in to the study in violation of this protocol or if the subject is uncooperative during the study. 6.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 concentrations of vitamin C in DELT vitamin C in comparison with conventional vitamin C and plain vitamin C supplementation. |
Period 1, Period 2, Period 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pharmacokinetics parameters of DELT vitamin C in comparison with conventional vitamin C and plain vitamin C. |
Baseline, Day 9, Day 17 |
| Safety and tolerability of DELT vitamin C in comparison with conventional vitamin C and plain vitamin C. |
Baseline, Day 9, Day 17 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
18/12/2025 |
| 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="3"
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 comparative single-dose, crossover, 3-sequence study to compare the bioavailability of DELT vitamin C in comparison with conventional vitamin C and plain vitamin C. A group of 12 Healthy volunteers willing to give a written informed consent will be screened on Visit 1 to confirm eligibility. Subjects fulfilling the eligibility criteria will be assigned into 1 of 3-treatment sequence on Visit 2 followed by cross-over to the other treatment sequences on subsequent visits. There will be washout period between each dosing day.
|