Virgin Coconut Oil Oral Supplementation for Leprosy Patients

April 3, 2017 updated by: Carmela Dayrit, Philippine Dermatological Society

The Effects of Virgin Coconut Oil Supplementation on Oxidative Stress and Treatment Response Among Hansen's Disease Patients on Multi-Drug Therapy: A Pilot Study

To date, there has been no clinical investigation on the effects of virgin coconut oil (VCO) oral supplementation on patients with Hansen's disease (HD) undergoing medical treatment. This study aims to examine the possible protective effect of exogenous supplementation of VCO on the oxidative stress, antioxidant status, and treatment response among HD patients. Treatment response will be defined as the clinical changes in cutaneous and neurologic manifestations as measured by the clinical response score. This study also aims to investigate the potential of VCO as an adjunct to Multi-Drug Therapy (MDT) in mitigating lepra reactions.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Objective: To determine the effect of co-administration of virgin coconut oil (VCO) oral supplementation and standard Multi-Drug Therapy (MDT) on malondialdehyde (MDA), superoxide dismutase (SOD), and glutathione (GSH) blood levels and to determine and compare treatment response between leprosy cases treated with MDT alone and cases treated with MDT with VCO supplementation.

Design: This is an open label, controlled clinical trial and a preliminary/phase 1 trial.

Setting: Patients seen in the out-patient clinic of the Section of Dermatology, Philippine General Hospital, a tertiary government hospital.

Participants: Twenty-six previously untreated Hansen's Disease (HD) patients, 18 years old and above, diagnosed clinically and confirmed histologically with HD.

Intervention: The 26 HD patients will be divided into two groups: group 1 will receive only MDT and group 2 will receive MDT with VCO supplementation. Both groups 1 and 2 will consist of 6 or 7 Paucibacillary (PB) patients and 6 or 7 Multibacillary (MB) patients. All participants will have MDA, SOD, and GSH blood levels taken on initial consult and on the third and sixth months. Treatment response will be measured by a clinical response score, which will be graded by a blinded investigator based on cutaneous manifestations (no change, moderate improvement, definite improvement, worse) and neurologic manifestations (no change, improvement, worse).

Main Outcome Measures: The mean and inter-quartile range of MDA, SOD, and GSH blood levels; bacterial index (BI) and morphological index (MI) from slit skin-smears; and treatment response based on the clinical response score. Frequency and severity of lepra reactions will also be noted.

Data Analysis: The following statistical tests will be used: Mann-Whitney test to compare the difference between median values of group 1 and group 2; Kruskal-Wallis Test for multiple comparisons; Wilcoxon signed ranks test for comparing differences in median values within groups; Fisher's exact test to compare the frequency of categorical data of treatment response (cutaneous manifestations); and T test for the quantitative data (neurologic manifestations) will be used. Values of p<0.05 will be considered statistically significant.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
      • Manila, Philippines, 1000
        • Philippine General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 18 years and above, male or female
  • Patients with clinical evidence and histological confirmation of lepromatous leprosy (LL), borderline lepromatous leprosy (BL), borderline leprosy (BB), borderline tuberculoid leprosy (BT), or tuberculoid leprosy (TT) according to the Ridley and Jopling classification and Paucibacillary (PB) or Multibacillary (MB) disease based on the World Health Organization (WHO) classification
  • Patients should not have been on MDT in the past
  • Patients with normal blood test results for complete blood count (CBC), liver aminotransaminases (AST, ALT), glucose-6-phosphate dehydrogenase (G6PD) assay, creatinine, lipid profile and chest x-ray

Exclusion Criteria:

  • HD patients with reactions needing prednisone therapy at time of diagnosis
  • Patients who are already taking VCO or any other oral or intravenous antioxidant supplements
  • Patients taking long term medications unrelated to leprosy
  • Pregnant women
  • Patients with history of smoking, co-infections such as tuberculosis, diabetes mellitus, any other systemic diseases or health problems
  • Patients not willing to return for follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Multi-Drug Therapy (Novartis Ⓡ)

Multi-Drug Therapy PB pack consists of 600 milligrams (mg) of rifampicin (NovartisⓇ) single dose once a month and 100mg of dapsone (NovartisⓇ) daily for six months (PB patients)

Multi-Drug Therapy MB pack consists of 600mg of rifampicin (NovartisⓇ), 300mg of clofazimine (NovartisⓇ) as a single dose monthly and 50mg of clofazimine (NovartisⓇ) and 100mg of dapsone (NovartisⓇ) daily for six months (MB patients)
Other: Multi-Drug Therapy (Novartis Ⓡ)
The MDT is provided by the World Health Organization (WHO) and NovartisⓇ. The MB pack consists of Rifampicin (300mg/tab x 2 tablets), Clofazimine (100mg/tab x 3 tabs and 50mg/tab x 28 tabs), Dapsone (100mg/tab x 29 tabs) and the PB pack consists of Rifampicin (300mg/tab x 2 tablets) and Dapsone (100mg/tab x 29 tabs).
Other Names:
  • MDT
Experimental: Virgin Coconut Oil (VCO) with MDT

VCO 10 milliliters (mL) three times a day in addition to MDT of 600mg of rifampicin (NovartisⓇ) single dose once a month and 100mg of dapsone (NovartisⓇ) daily for a period of six months (PB patients)

VCO 10mL three times a day in addition to MDT of 600mg of rifampicin (NovartisⓇ), 300mg of clofazimine (NovartisⓇ) as a single dose monthly and 50mg of clofazimine (NovartisⓇ) and 100mg of dapsone (NovartisⓇ) daily or a period of six months (MB patients)
Other: Multi-Drug Therapy (Novartis Ⓡ)
The MDT is provided by the World Health Organization (WHO) and NovartisⓇ. The MB pack consists of Rifampicin (300mg/tab x 2 tablets), Clofazimine (100mg/tab x 3 tabs and 50mg/tab x 28 tabs), Dapsone (100mg/tab x 29 tabs) and the PB pack consists of Rifampicin (300mg/tab x 2 tablets) and Dapsone (100mg/tab x 29 tabs).
Other Names:
  • MDT
Dietary supplement: Virgin Coconut Oil
cold-processed VCO
Other Names:
  • VCO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Bacterial Indices
Time Frame: The Bacterial Index (BI) and Morphologic Index (MI) will be determined from the slit skin smears of the patients on initial consult and at the sixth month of treatment.
The Bacterial Index (BI) and Morphologic Index (MI) will be determined from the slit skin smears of the patients on initial consult and at the sixth month of treatment.
Change in Oxidative Stress Markers
Time Frame: The oxidative stress markers will be measured in blood on initial consult, on the third month, and at the sixth month of treatment.
The oxidative stress markers consist of Malondialdehyde (MDA), Superoxide Dismutase (SOD), and Glutathione (GSH) levels.
The oxidative stress markers will be measured in blood on initial consult, on the third month, and at the sixth month of treatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Clinical Response Score (CRS)
Time Frame: A blinded outcome assessor will take the CRS for changes in the skin and nerves on initial consult and every 4 weeks after over the study period of 24 weeks.
A blinded outcome assessor will take the CRS for changes in the skin and nerves on initial consult and every 4 weeks after over the study period of 24 weeks.
Lepra reactions
Time Frame: The frequency of lepra reactions (type 1 or type 2) will be noted throughout the study period of 24 weeks. The severity of these reactions will be graded.
The frequency of lepra reactions (type 1 or type 2) will be noted throughout the study period of 24 weeks. The severity of these reactions will be graded.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Adverse events will be noted every 4 weeks from initial consult for a total of 24 weeks.
Adverse events will be noted every 4 weeks from initial consult for a total of 24 weeks.
Patients' assessment of VCO
Time Frame: At the 24th week (on final follow-up), the patients in group 2 will be asked to answer the VCO assessment questionnaire.
The following characteristics of VCO will be noted: taste/palatability, smell, ease of ingestion, efficacy, and degree of compliance.
At the 24th week (on final follow-up), the patients in group 2 will be asked to answer the VCO assessment questionnaire.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philippine Dermatological Society

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

June 14, 2013

First Submitted That Met QC Criteria

June 20, 2013

First Posted (Estimate)

June 25, 2013

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

April 3, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDS_PGH_2013_003
  • UPMREB MED-2013-P3-053 (Registry Identifier: University of the Philippines, Manila Research Ethics Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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