Evaluation of the Ocular Safety of Calcium Formate in Normal, Healthy Female Subjects
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Jul 2003
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedMarch 7, 2019
March 1, 2019
3.7 years
September 12, 2005
March 5, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Vision Testing (refraction) over baseline
Participants will be refracted at baseline and the resultant lens correction will be used for testing visual acuity at all subsequent visits. If a participant's visual acuity drops 10 letters or more at any visit, the participant will be re-refracted and the visual acuity will be tested again with the new lens correction in place.
Up to 15 days
Change in Serum Formate Levels over baseline
To test for accumulation of formate, morning blood samples for determination of formate will be obtained at screening, prior to administration of the first dose of calcium formate on Study Days 1, 2, 3, and 8 and on day 15. Blood samples for determination of formate will also be obtained approximately 40-60 minutes after ingestion of the second dose on Study Days 1, 2 and 3.
Up to 15 days
Secondary Outcomes (5)
Change in Visual Acuity over baseline
Up to 15 days
Change in 100 Hue Vision Testing results over baseline
Up to 15 days
Change in ERG/VEP over baseline
Up to 15 days
Change in Visual Fields over baseline
Up to 15 days
Fundus Photography
Up to 15 days
Study Arms (1)
Open label
EXPERIMENTALEach participant will be treated with three 3900 mg doses of calcium formate on each study day (i.e., days 1-14).
Interventions
Calcium formate - Each uncoated white tablet will contain 650 mg of calcium formate, (equivalent to 200 mg elemental calcium). Nephro-Tech, LLC, will formulate and provide the calcium formate tablets for the study.
Eligibility Criteria
You may qualify if:
- Healthy females
You may not qualify if:
- no ocular diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Wisconsin, Madisonlead
- Nephro-Tech 1, LLCcollaborator
Study Sites (1)
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Related Publications (1)
Altaweel MM, Hanzlik RP, Ver Hoeve JN, Eells J, Zhang B. Ocular and systemic safety evaluation of calcium formate as a dietary supplement. J Ocul Pharmacol Ther. 2009 Jun;25(3):223-30. doi: 10.1089/jop.2008.0128.
PMID: 19456257RESULT
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Michael M Altaweel, MD
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
July 1, 2003
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
March 7, 2019
Record last verified: 2019-03