Nutritional Supplements and Performance During Visual Field Testing (B3 Vitamin)
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|ClinicalTrials.gov Identifier: NCT03797469|
Recruitment Status : Completed
First Posted : January 9, 2019
Last Update Posted : November 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Visual Field Defect, Peripheral Glaucoma, Open-Angle||Dietary Supplement: Vitamin B3 Dietary Supplement: Pyruvate Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Nutritional Supplements and Performance During Visual Field Testing|
|Actual Study Start Date :||April 15, 2019|
|Actual Primary Completion Date :||December 31, 2020|
|Actual Study Completion Date :||December 31, 2020|
Active Comparator: Nicotinamide and Pyruvate (N&P)
This group will receive two separate sets of tablets containing 3 x 1000 mg of Vitamin B3 (nicotinamide) and 2 x 1500 mg of Pyruvate.
Dietary Supplement: Vitamin B3
3 tablets of 1000 mg each will be administered orally.
Other Name: B-3 Nicotinamide
Dietary Supplement: Pyruvate
2 tablets of 1500 mg each will be administered orally.
Other Name: Calcium Pyruvate
Placebo Comparator: Placebo
This group will receive an equal number of tablets as the N&P group.
Dietary Supplement: Placebo
Tablets will look identical to the supplements and the number of tablets will equal the amount of supplements provided.
- Change in 24-2 visual field test [ Time Frame: Up to 20 weeks ]Changes in 24-2 visual field results based upon point-wise and global metrics before and after intervention, and between treatment and placebo groups will be compared.
- Change in Montreal Cognitive Assessment (MoCA) scores [ Time Frame: Up to 20 weeks ]Montreal Cognitive Assessment (MoCA) score before and after intervention and correlate these changes with those seen on visual field tests will be compared. The Montreal Cognitive Assessment (MoCA) is a brief 30-question test that assesses different types of cognitive abilities. Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03797469
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Jeffrey M Liebmann, MD||Columbia University|