A Randomized Controlled Trial on the Efficacy and Safety of Virgin Coconut Oil Compared to Mineral Oil in the Treatment of Uremic Xerosis
| Registry | NCT01445431 |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional; randomized, single group, masking: single, treatment |
| Enrollment | 45 (Actual) |
| Sponsor | University of the Philippines (Other) |
| Conditions | Uremic Xerosis |
| Interventions | Virgin Coconut Oil, Mineral Oil (Other) |
| Dates | start 2011-04-01, primary completion 2011-08-01, completion 2011-08-01, first posted 2011-10-03, last updated 2011-10-03 |
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All trials for Uremic Xerosis All trials of Virgin Coconut Oil All trials of Mineral Oil
Among adult patients with chronic kidney disease undergoing hemodialysis, what is the efficacy and safety of virgin coconut oil compared to mineral oil as a therapeutic moisturizer for uremic xerosis?
Objectives of the Study: The general objective of this study is to assess the efficacy and safety of virgin coconut oil (VCO) compared to mineral oil as a therapeutic moisturizer for uremic xerosis. The specific objectives are as follows: 1) to determine and compare changes in the over-all dry skin score within and between treatment groups at baseline, 2 weeks-post and 4-weeks post application; 2) to quantitatively measure the following skin parameters at baseline, 2-weeks and 4-weeks post application (skin hydration using a corneometer, skin lipids using a sebumeter); 3) to determine and compare changes in quality of life scores within and between treatment groups at baseline, and 4-weeks post application; and 4) to identify the adverse effects of virgin coconut oil and mineral oil when used as moisturizer for uremic xerosis
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Virgin Coconut Oil | Experimental | Other: Virgin Coconut Oil | |
| Mineral Oil | Active comparator | Other: Mineral Oil |
Sex: All, ages: 19 Years to 65 Years
Inclusion Criteria: * Adults undergoing maintenance hemodialysis who have mild to severe uremic xerosis Exclusion Criteria: * Patients with known hypersensitivity to the tests oils were excluded from the study as well as patients with open wounds, erosions, and ulcers on the test site and paraplegics and patients with altered sensation on the test sites. * Patients with xerosis associated with other dermatologic conditions antedating renal failure were excluded from the study.