Nutritional Supplements and Performance During Visual Field Testing (B3 Vitamin)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03797469|
Recruitment Status : Not yet recruiting
First Posted : January 9, 2019
Last Update Posted : January 9, 2019
|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)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Nutritional Supplements and Performance During Visual Field Testing|
|Estimated Study Start Date :||April 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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
|Contact: Carlos Gustavo De Moraes, MD, MPHemail@example.com|
|Contact: Lisa Hark, PhDfirstname.lastname@example.org|
|United States, New York|
|Columbia University Medical Center||Not yet recruiting|
|New York, New York, United States, 10032|
|Contact: Carlos Gustavo De Moraes, MD, MPH email@example.com|
|Contact: Lisa M Hark, PhD firstname.lastname@example.org|
|Principal Investigator: Jeffrey M Liebmann, MD|
|Sub-Investigator: George A Cioffi, MD|
|Principal Investigator:||Jeffrey M Liebmann, MD||Columbia University|