CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Blackmores Omega Daily (4 1g capsules per day)dietary
Likely dose
Blackmores Omega Daily (4 1g capsules per day)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04222660
NCT04222660N/ACompleted

Diabetic Neuropathy: Function-Structure of Corneal Nerves to Assess Injury-Repair

VA Office of Research and Development·interventional·Posted Jan 10, 2020·Updated May 23, 2025

In Brief

A clinical study evaluating Blackmores Omega Daily (4 1g capsules per day) for Diabetic Peripheral Neuropathy. Completed, enrolled 44 participants across 1 site.

Detailed Summary

Peripheral neuropathy affects about 50% of the diabetic population and there is no treatment other than good blood glucose control, which is ineffective in subjects with type 2 diabetes. Part of the problem for the lack of an effective treatment is the inability to detect peripheral neuropathy in its early stage. The hypotheses to be addressed in the first phase of this study is that changes in cornea sensitivity (blinking and squinting) following addition of a hyperosmotic solution will provide a novel screening tool for early diagnosis of peripheral neuropathy. For the second phase of the study the investigators will examine the effect of fish oil treatment of diabetic subjects with neuropathy on corneal nerve density and sensitivity. Corneal nerves are the most highly innervated part of the human body with great sensitivity. The first phase will use this property and determine whether sensitivity is lost in diabetic patients with neuropathy. Preclinical studies have supported this hypothesis and now this will be tested in human subjects. Preclinical studies have also shown that treating diabetic rodents with fish oil improves nerve regeneration and outcome measures of peripheral in diabetic rodents. In the second phase the investigators will perform preliminary studies in human subjects with diabetic neuropathy and determine whether treating them with fish oil increases corneal nerve density and sensitivity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 10, 2020
Enrollment StartJun 21, 2021
Primary CompletionJun 5, 2023
Study CompletionMay 13, 2025
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.5 years ago

Interventions

Blackmores Omega Daily (4 1g capsules per day)dietary

Subjects enrolled in phase two of the study will be instructed to take 4 capsules per day (2 in the morning and 2 in the evening). Each capsule contains 1000 mg of triglyceride; 35% eicosapentaenoic acid and 25% docosahexaenoic acid.