| CTRI Number |
CTRI/2022/05/042364 [Registered on: 04/05/2022] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To Evaluate Efficacy of Lutemax 2020 (Lutein 10 mg & Zeaxanthin Isomers 2 mg) on Vision and Cognitive Performance in Healthy Children. |
|
Scientific Title of Study
|
A Prospective, Randomized, Double-Blind, Parallel, Placebo- Controlled Study to Evaluate
Efficacy of Lutemax 2020 (Lutein 10 mg & Zeaxanthin Isomers 2 mg) on Vision and
Cognitive Performance in Children. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BIAG-CSP-052 Version 1.0 dated 24-March-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajesh Parekh |
| Designation |
Principal Investigator |
| Affiliation |
Sanjeevani Netralaya |
| Address |
141, Infantry road (Bhagwan Mahaveer road) Opp. The Hindu, Near income tax office Bangalore- 560001
Bangalore
KARNATAKA
560001
India |
| Phone |
08041204067 |
| Fax |
|
| Email |
vision6by6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya C |
| Designation |
CEO |
| Affiliation |
Bioagile Therapeutics Limited |
| Address |
#2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage,, Bengaluru, Karnataka 560094
Bangalore
KARNATAKA
560094
India |
| Phone |
9538961761 |
| Fax |
|
| Email |
Divya@bioagiletherapeutics.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya C |
| Designation |
CEO |
| Affiliation |
Bioagile Therapeutics Limited |
| Address |
#2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage,, Bengaluru, Karnataka 560094
Bangalore
KARNATAKA
560094
India |
| Phone |
9538961761 |
| Fax |
|
| Email |
Divya@bioagiletherapeutics.com |
|
|
Source of Monetary or Material Support
|
| Sanjeevani Netralaya
141, Infantry road (Bhagwan Mahaveer road) Opp. The Hindu, Near income tax office Bangalore- 560001
|
|
|
Primary Sponsor
|
| Name |
OmniActive Health Technologies Ltd |
| Address |
T-8b, 5th Floor, Phoenix House, A wing
Phoenix Mills Compound
462 Senapati Bapat Marg
Lower Parel, Mumbai – 400013
India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Rajesh Parekh |
Sanjeevani Netralaya |
Sanjeevani Netralaya,141,Infantry road (Bhagwan Mahaveer road)Opp. The Hindu, Near income tax office
Bangalore- 560001
Bangalore
KARNATAKA |
9686804844
vision6by6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lutemax 2020â„¢ |
Lutemax 2020â„¢ is a patented extract containing all three nutritionally relevant macular
carotenoids—lutein, RR-zeaxanthin, and RS (meso)-zeaxanthin— in the same 5:1 ratio
as found in the diet. Naturally derived from marigold flowers.Duration Once a Day for 6 months |
| Comparator Agent |
Standard of Care (SOC) treatment |
A standard of care (SOC) treatment shall be advised at the investigator’s discretion, and End of Study visit procedures shall be performed for this purpose..Duration 6 months |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children (Male/female) of ≥5 and ≤12 years of age.
2.Participants with BMI equal to or greater than the 5th percentile and less than the 85th percentile for age, gender, and height.
3.Participants with screen time i.e., exposure to digital devices for minimum of 4 hours per day.
4.Participants who agree to maintain their usual dietary habits throughout the trial period.
5.Participants who agree to maintain their usual level of activity throughout the trial period.
|
|
| ExclusionCriteria |
| Details |
1.Participants ˂ 5 or ˃ 12 years of age.
2.Participants having hypersensitivity or history of allergy to the study product or any of its ingredients.
3.Participants suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator.
4.Participants having a current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the subject unlikely to fully complete the study or any condition that presents undue risk from the study product or procedures in the opinion of the investigator
5.Participants with a recent history (3 months) of serious infections, injuries and/ or surgeries.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in Macular Pigment Optical Density (MPOD) from Baseline (Day -7 to Day -1) to Visit 5, End of Study Visit (Day 180 + 3 days) |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Mean change in visual processing speed from Baseline (Day-7 to Day-1) to Visit 5, End of Study Visit (Day 180 plus 3 days)
2.Mean change in contrast sensitivity from Baseline (Day -7 to Day -1) to Visit 5, End of Study Visit (Day 180 plus 3 days)
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
05/05/2022 |
| Date of Study Completion (India) |
23/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Extensive exposure to digital devices like laptops, smart phones, etc.is a result of advanced technology in today’s modern world. Especially, the children of 21st century are avid users of technology. The precipitous rise in the use of digital devices has raised concerns about potentially deleterious health effects due to increased screen time and associated exposure to short wavelength blue light. Adverse effects include damage to retina, physical health and cognitive performance. To adapt to this change, a diet-derived, blue-absorbing pigment, composed of the dietary carotenoids lutein (L) and zeaxanthin (Z), which are found in relatively high concentrations in leafy-green vegetables, and along with the Z isomer mesozeaxanthin (MZ), are deposited in rich concentrations in the macular retina. They play an important role in protecting the retina from cumulative damage that can result in visual and cognitive detriments and further progress to Age-related Macular Degeneration (AMD) (Seddon, J.M.et.al., 1994, Richer, S. et.al., 2004) .
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