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A Trial on the Efficacy and Safety of Virgin Coconut Oil Compared to Mineral Oil in the Treatment of Uremic Xerosis

NCT ID: NCT01445431

Last Updated: 2011-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-08-31

Brief Summary

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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?

Detailed Description

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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

Conditions

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Uremic Xerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Virgin Coconut Oil

Group Type EXPERIMENTAL

Virgin Coconut Oil

Intervention Type OTHER

Virgin coconut oil applied to the test site twice daily for four weeks

Mineral Oil

Group Type ACTIVE_COMPARATOR

Mineral Oil

Intervention Type OTHER

Mineral oil applied to the test site twice daily for four weeks

Interventions

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Virgin Coconut Oil

Virgin coconut oil applied to the test site twice daily for four weeks

Intervention Type OTHER

Mineral Oil

Mineral oil applied to the test site twice daily for four weeks

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of the Philippines

OTHER

Sponsor Role lead

Responsible Party

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Jacqueline Michelle G. de las Alas, M.D.

Medical Officer III

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jacqueline Michelle G de las Alas, MD

Role: PRINCIPAL_INVESTIGATOR

University of the Philippines

Other Identifiers

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MED 2011-01-03-005

Identifier Type: -

Identifier Source: org_study_id