Healthy
Conditions
Brief summary
This is a Phase I, single center, open-label study of the dietary supplement calcium formate in normal, healthy female subjects. The purpose of the study is to determine whether daily use of calcium formate is safe and whether it accumulates in the eye.
Detailed description
This is a Phase I, single center, open-label study of the dietary supplement calcium formate in normal, healthy female subjects. The purpose of the study is to determine whether daily use of calcium formate is safe and whether it accumulates in the eye.
Interventions
DRUGcalcium formate
Calcium formate - Each uncoated white tablet will contain 650 mg of calcium formate, (equivalent to 200 mg elemental calcium). Nephro-Tech, LLC, will formulate and provide the calcium formate tablets for the study.
Sponsors
Nephro-Tech 1, LLC
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy females
Exclusion criteria
* no ocular diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vision Testing (refraction) over baseline | Up to 15 days | Participants will be refracted at baseline and the resultant lens correction will be used for testing visual acuity at all subsequent visits. If a participant's visual acuity drops 10 letters or more at any visit, the participant will be re-refracted and the visual acuity will be tested again with the new lens correction in place. |
| Change in Serum Formate Levels over baseline | Up to 15 days | To test for accumulation of formate, morning blood samples for determination of formate will be obtained at screening, prior to administration of the first dose of calcium formate on Study Days 1, 2, 3, and 8 and on day 15. Blood samples for determination of formate will also be obtained approximately 40-60 minutes after ingestion of the second dose on Study Days 1, 2 and 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in ERG/VEP over baseline | Up to 15 days | Change in electroretinography (ERG) and visual-evoked potential will be monitored over baseline. |
| Change in Visual Acuity over baseline | Up to 15 days | Based on retroilluminated Chart R from Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) distance visual acuity chart set. |
| Fundus Photography | Up to 15 days | Stereoscopic color fundus photographs of both eyes will be taken with a 30 degree fundus camera at baseline, at day 2 and day 8 of study tablet administration 40-60 minutes after the second dose, and at study completion (day 15), early termination, or if a vision drop or AE occurs. These will be compared individually for changes including macular edema, retinal or optic nerve abnormalities or other abnormalities occurring from baseline. |
| Change in Visual Fields over baseline | Up to 15 days | Automated standardized Humphrey 24-2 visual fields will be performed using the SITA (Swedish Interactive Threshold Algorithm) protocol. This test is standard of care for the assessment and follow-up of optic nerve disorders such as glaucoma or optic neuropathy. It will be performed in the customary manner for evaluation of mean defect. |
| Change in 100 Hue Vision Testing results over baseline | Up to 15 days | The FM-100 Hue test will be utilized to assess color vision at baseline and at the conclusion of the study. This test requires the arrangement of 100 discs of varying hues in an orderly sequence. The test requires 15 minutes to complete and is noninvasive. The test is scored by a computer. |
Countries
United States
Outcome results
None listed