NCT00204893|CompletedPhase 1DMC
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Sponsor study identifier
interventional
12
1 country
1
Study Start
July 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2007
Actual (reported)Study Completion
March 2007
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2007
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2003
Date type not reportedThis date has not been verified as actual or estimated.
September 12, 2005
Actual (reported)September 20, 2005
Actual (reported)March 2007
Actual (reported)March 2007
Actual (reported)Vision Testing (refraction) over baseline
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.
Up to 15 days
Change in Serum Formate Levels over baseline
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.
Up to 15 days
Change in Visual Acuity over baseline
Up to 15 days
Change in 100 Hue Vision Testing results over baseline
Up to 15 days
Change in ERG/VEP over baseline
Up to 15 days
Change in Visual Fields over baseline
Up to 15 days
Fundus Photography
Up to 15 days
Each participant will be treated with three 3900 mg doses of calcium formate on each study day (i.e., days 1-14).
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Altaweel MM, Hanzlik RP, Ver Hoeve JN, Eells J, Zhang B. Ocular and systemic safety evaluation of calcium formate as a dietary supplement. J Ocul Pharmacol Ther. 2009 Jun;25(3):223-30. doi: 10.1089/jop.2008.0128.
Michael M Altaweel, MD
University of Wisconsin, Madison
12 participants (actual enrollment reported by the registry).
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
July 2003
Date type not reportedThis date has not been verified as actual or estimated.
15 mg Mirtazapine Orally Disintegrating Tablets, Non-Fasting
Contact the study team to confirm eligibility.
Primary Completion
March 2007
Actual (reported)Study Completion
March 2007
Actual (reported)Last Updated
March 7, 2019
Record last verified: 2019-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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