NCT01445431

Brief Summary

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?

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2011

Completed
Last Updated

October 3, 2011

Status Verified

September 1, 2011

Enrollment Period

4 months

First QC Date

September 26, 2011

Last Update Submit

September 29, 2011

Conditions

Uremic Xerosis

Outcome Measures

Primary Outcomes (3)

  • Change in baseline overall dry skin score

    4 weeks

  • Change in baseline corneometer readings

    Measurement of skin hydration

    4 weeks

  • Change in baseline sebumeter readings

    Measurement of skin lipids

    4 weeks

Secondary Outcomes (3)

  • Change in Quality of life scores

    4 weeks

  • Patient-assessed efficacy

    4 weeks

  • Adverse events

    4 weeks

Study Arms (2)

Virgin Coconut Oil

EXPERIMENTAL
Other: Virgin Coconut Oil

Mineral Oil

ACTIVE COMPARATOR
Other: Mineral Oil

Interventions

Virgin Coconut OilOTHER

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

Virgin Coconut Oil
Mineral OilOTHER

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

Mineral Oil

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults undergoing maintenance hemodialysis who have mild to severe uremic xerosis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Mineral Oil

Intervention Hierarchy (Ancestors)

PetrolatumHydrocarbonsOrganic Chemicals

Study Officials

  • Jacqueline Michelle G de las Alas, MD

    University of the Philippines

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Officer III

Study Record Dates

First Submitted

September 26, 2011

First Posted

October 3, 2011

Study Start

April 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

October 3, 2011

Record last verified: 2011-09