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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	University of Wisconsin, Madison Nephro-Tech 1, LLC
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00204893

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: calcium formate	Phase I

MedlinePlus related topics: Calcium

Drug Information available for: Calcium gluconate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Evaluation of the Ocular Safety of Calcium Formate in Normal, Healthy Female Subjects

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

vision testing
serum formate levels

Secondary Outcome Measures:

visual acuity
color vision
ERG/VEP
visual fields
fundus photography

Estimated Enrollment:	12
Study Start Date:	July 2003

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy females

Exclusion Criteria:

no ocular diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204893

Locations

United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Nephro-Tech 1, LLC

Investigators

Principal Investigator:

Michael M Altaweel, MD

University of Wisconsin, Madison

More Information

Study ID Numbers:	2003-297
Study First Received:	September 12, 2005
Last Updated:	October 31, 2008
ClinicalTrials.gov Identifier:	NCT00204893
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Calcium, Dietary
Healthy

ClinicalTrials.gov processed this record on January 16, 2009