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

University of Wisconsin (UW)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: calcium formate

Study type: Interventional

Funder types: Other

Identifiers

NCT00204893

2003-297

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy females

Exclusion criteria

• no ocular diseases

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Open label

Experimental group

Description:

Each participant will be treated with three 3900 mg doses of calcium formate on each study day (i.e., days 1-14).

Treatment:

Drug: calcium formate