Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT00204893
Status:
COMPLETED
Last Update Posted:
2019-03-07
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Ocular Safety of Calcium Formate in Normal, Healthy Female Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C030544', 'term': 'formic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-05', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-19', 'lastUpdatePostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vision Testing (refraction) over baseline', 'timeFrame': 'Up to 15 days', 'description': "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."}, {'measure': 'Change in Serum Formate Levels over baseline', 'timeFrame': 'Up to 15 days', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Visual Acuity over baseline', 'timeFrame': 'Up to 15 days', 'description': 'Based on retroilluminated Chart R from Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) distance visual acuity chart set.'}, {'measure': 'Change in 100 Hue Vision Testing results over baseline', 'timeFrame': 'Up to 15 days', 'description': 'The FM-100 Hue test will be utilized to assess color vision at baseline and at the conclusion of the study. This test requires the arrangement of 100 discs of varying hues in an orderly sequence. The test requires 15 minutes to complete and is noninvasive. The test is scored by a computer.'}, {'measure': 'Change in ERG/VEP over baseline', 'timeFrame': 'Up to 15 days', 'description': 'Change in electroretinography (ERG) and visual-evoked potential will be monitored over baseline.'}, {'measure': 'Change in Visual Fields over baseline', 'timeFrame': 'Up to 15 days', 'description': 'Automated standardized Humphrey 24-2 visual fields will be performed using the SITA (Swedish Interactive Threshold Algorithm) protocol. This test is standard of care for the assessment and follow-up of optic nerve disorders such as glaucoma or optic neuropathy. It will be performed in the customary manner for evaluation of mean defect.'}, {'measure': 'Fundus Photography', 'timeFrame': 'Up to 15 days', 'description': 'Stereoscopic color fundus photographs of both eyes will be taken with a 30 degree fundus camera at baseline, at day 2 and day 8 of study tablet administration 40-60 minutes after the second dose, and at study completion (day 15), early termination, or if a vision drop or AE occurs. These will be compared individually for changes including macular edema, retinal or optic nerve abnormalities or other abnormalities occurring from baseline.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '19456257', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy females\n\nExclusion Criteria:\n\n* no ocular diseases'}, 'identificationModule': {'nctId': 'NCT00204893', 'briefTitle': 'Evaluation of the Ocular Safety of Calcium Formate in Normal, Healthy Female Subjects', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Evaluation of the Ocular Safety of Calcium Formate in Normal, Healthy Female Subjects', 'orgStudyIdInfo': {'id': '2003-297'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open label', 'description': 'Each participant will be treated with three 3900 mg doses of calcium formate on each study day (i.e., days 1-14).', 'interventionNames': ['Drug: calcium formate']}], 'interventions': [{'name': 'calcium formate', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Open label']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Hospital and Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Michael M Altaweel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nephro-Tech 1, LLC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}