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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Nephro-Tech 1, LLC
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00204893
First received: September 12, 2005
Last updated: October 28, 2013
Last verified: October 2013
  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: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00204893     History of Changes
Other Study ID Numbers: 2003-297
Study First Received: September 12, 2005
Last Updated: October 28, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 15, 2014