CTRI/2022/05/042364CompletedUnknown
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.
OmniActive Health Technologies Ltd1 site in 1 country60 target enrollmentStarted: May 5, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 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)
Study Overview
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) .
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 5.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •1.Participants Ë‚ 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.
Outcomes
Primary Outcomes
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)
Time Frame: 6 months
Secondary Outcomes
- 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))
Investigators
Study Sites (1)
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