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Completed

NCT Number: NCT00204893

Evaluation of the Ocular Safety of Calcium Formate in Normal, Healthy Female Subjects

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy females

Exclusion criteria

  • no ocular diseases

Treatment and study plan

Calcium Formate

Drug

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.

Primary outcomes

  1. Vision Testing (refraction) over baseline

    Time frame: 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.

  2. Change in Serum Formate Levels over baseline

    Time frame: 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 outcomes

  1. Change in Visual Acuity over baseline

    Time frame: Up to 15 days

    Based on retroilluminated Chart R from Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) distance visual acuity chart set.

  2. Change in 100 Hue Vision Testing results over baseline

    Time frame: 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.

  3. Change in ERG/VEP over baseline

    Time frame: Up to 15 days

    Change in electroretinography (ERG) and visual-evoked potential will be monitored over baseline.

  4. Change in Visual Fields over baseline

    Time frame: 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.

  5. Fundus Photography

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Nephro-Tech 1, LLC

Registry information

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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