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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00204893
First Posted: September 20, 2005
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Nephro-Tech 1, LLC
Information provided by:
University of Wisconsin, Madison
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
  • ERG/VEP
  • 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)
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Healthy females

Exclusion Criteria:

  • no ocular diseases
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00204893     History of Changes
Other Study ID Numbers: 2003-297
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: October 31, 2017
Last Verified: October 2013

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs