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CTRI Number  CTRI/2024/04/066202 [Registered on: 24/04/2024] Trial Registered Prospectively
Last Modified On: 21/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Bioavailability study on Healthy subjects 
Scientific Title of Study   A Randomized, Open label, two arm, cross-over trial to assess the bioavailability of liposomal and non-liposomal Vitamin-C formulations in healthy volunteers. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
RRS/CL/BA/LP1/2024 dated 11th March 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Godavarthi  
Designation  C E O 
Affiliation  Radiant Research Services Pvt. Ltd 
Address  Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru - 560058, Karnataka, India

Bangalore
KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  surya.ashok@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Godavarthi  
Designation  C E O 
Affiliation  Radiant Research Services Pvt. Ltd 
Address  Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru - 560058, Karnataka, India


KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  surya.ashok@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashok Godavarthi  
Designation  C E O 
Affiliation  Radiant Research Services Pvt. Ltd 
Address  Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru - 560058, Karnataka, India


KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  surya.ashok@gmail.com  
 
Source of Monetary or Material Support  
Botanic Healthcare Pvt Ltd TSIIC Industrial Development Area, Nacharam (V), Uppal (M), Hyderabad, Telangana – 500076, India  
 
Primary Sponsor  
Name  Botanic Healthcare Pvt Ltd 
Address  TSIIC Industrial Development Area, Nacharam (V), Uppal (M), Hyderabad, Telangana – 500076 
Type of Sponsor  Other [Nutraceutical supplement company] 
 
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 
DrAmbrish C  Medstar Speciality Hospital  641/17/1/3, Medstar Speciality Hospital, Ground floor Room number 3 Kodigehalli Main Rd, Shanthivana, Sahakarnagar, Bengaluru, Karnataka 560092
Bangalore
KARNATAKA 		 9611934655

drambishmedstar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medstar Speciality Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Subjects 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Liposomal Vitamin C  Dose:500mg Dosage: Capsules Duration : Period I Day 1 Day 2 Washout period for 5±2 days Period II Day 1 Day 2  
Comparator Agent  Non-liposomal Vitamin C  Dose:500mg Dosage: Capsules Duration : Period I Day 1 Day 2 Washout period for 5±2 days Period II Day 1 Day 2 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Subjects must be healthy human male and female (non-pregnant) subjects.
2. Age should be between 18-45 years of age (both inclusive)
3. BMI between 18.5 to 24
4. Subject who are ready to provide written informed consent and should be willing to be available throughout the study duration and should follow the guidelines mentioned in the protocol.
5. Subjects with no evidence of underlying disease during the pre-study screening. They must be healthy as determined by medical history and physical examination, ECG, Chest X-ray (PA View) and laboratory tests performed within 7 days prior to the commencement of the study.
6. Subjects whose screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.
 
 
ExclusionCriteria 
Details  1. Subjects who are allergic to vitamin C products or any food or other drugs.
2. Subject with resting hypotension (BP less than90 /60) or hypertension (BP greterthan140 /90) and pulse rate below 50 min and more than 100/min.
3. Subject with or a prior history or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, musculoskeletal or psychiatric disease or who has been hospitalized or underwent surgery within the last 4 weeks prior to in-housing.
4. Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Asthma, Renal Impairment, Epilepsy and Intracranial haemorrhage.
5. Subjects who have taken over the counter or prescribed medications including any enzyme modifying drugs or many vitamin supplements within the last 14 days prior to the study.
6. Subject who has a history of alcoholism, drug abuse or Smoking.
7. Subjects who are hypersensitive to Heparin
8. Subjects who participated in any other clinical study in the past three months.
9. Subject with clinically significant abnormal lab values/ abnormal ECG abnormal Chest X ray (PA View).
10. Subject who has difficulty with donating blood.
11. Subject with history of difficulty in swallowing.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine the bioavailability of Vitamin C in liposomal and non-liposomal Vitamin C formulations in plasma by LC-MS/HPLC  Period I
Visit 1: Day 1
Visit 2: Day 2

Blood Sampling Point:0min, 30min, 60min, 90min, 120min, 3hrs, 4hrs, 6hrs, 8hrs, 12hrs and 24hrs.
Washout period for 5±2 days
Period II
Visit 1: Day 1
Visit 2: Day 2
 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety and tolerability of a single dose of liposomal Vitamin C formulations by reviewing adverse events  Period I
Visit 1: Day 1
Visit 2: Day 2
Washout period for 5±2 days
Period II
Visit 1: Day 1
Visit 2: Day 2
 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   26/04/2024 
Date of Study Completion (India) 10/06/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Liposomes are spherical shells made up of a double layer of fatty acids similar to the natural layer that makes up the outer membrane of the body’s cells.” Liposomes are known to be the best inter-cell transporters because they are made of the same lipids that make up the cell membranes and hence allows lipid-soluble nutrients inside.
Liposomal Vitamin C is basically Vitamin C in a liposome. The liposomes are very small and they mimic our cells. This means that liposomal Vitamin C avoids the digestive system that usually extends the absorption process. The main differences between liposomal Vitamin C and traditional Vitamin C have got to do with their bioavailability. The traditional Vitamin C is soluble in water and therefore its bioavailability is very low. Only about 12%-14% of regular Vitamin C is absorbed when it is taken orally. However, in liposomal form, Vitamin C is being delivered directly into the cells of one’s body, without being degraded and also without consuming energy in the process, and hence maximizing the benefit
 
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