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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by University of Wisconsin, Madison.
Recruitment status was:  Active, not recruiting
Nephro-Tech 1, LLC
Information provided by:
University of Wisconsin, Madison Identifier:
First received: September 12, 2005
Last updated: October 28, 2013
Last verified: October 2013
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
Drug: calcium formate
Phase 1

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

Resource links provided by NLM:

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
  • visual fields
  • fundus photography

Estimated Enrollment: 12
Study Start Date: July 2003
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy females

Exclusion Criteria:

  • no ocular diseases
  Contacts and Locations
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Please refer to this study by its identifier: NCT00204893

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
Principal Investigator: Michael M Altaweel, MD University of Wisconsin, Madison
  More Information Identifier: NCT00204893     History of Changes
Other Study ID Numbers: 2003-297
Study First Received: September 12, 2005
Last Updated: October 28, 2013

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on May 24, 2017