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Virgin Coconut Oil Oral Supplementation for Leprosy Patients

Primary Purpose

Hansen's Disease

Status
Withdrawn
Phase
Phase 1
Locations
Philippines
Study Type
Interventional
Intervention
Multi-Drug Therapy (Novartis Ⓡ)
Virgin Coconut Oil
Sponsored by
Philippine Dermatological Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hansen's Disease focused on measuring Leprosy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Philippine General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Multi-Drug Therapy (Novartis Ⓡ)

Virgin Coconut Oil (VCO) with MDT

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Change in Bacterial Indices
Change in Oxidative Stress Markers
The oxidative stress markers consist of Malondialdehyde (MDA), Superoxide Dismutase (SOD), and Glutathione (GSH) levels.

Secondary Outcome Measures

Change in Clinical Response Score (CRS)
Lepra reactions

Full Information

First Posted
June 14, 2013
Last Updated
April 3, 2017
Sponsor
Philippine Dermatological Society
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1. Study Identification

Unique Protocol Identification Number
NCT01885611
Brief Title
Virgin Coconut Oil Oral Supplementation for Leprosy Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
There was a problem with funding and with the acquisition of the lab assays
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philippine Dermatological Society

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hansen's Disease
Keywords
Leprosy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multi-Drug Therapy (Novartis Ⓡ)
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Virgin Coconut Oil (VCO) with MDT
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Multi-Drug Therapy (Novartis Ⓡ)
Other Intervention Name(s)
MDT
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Virgin Coconut Oil
Other Intervention Name(s)
VCO
Intervention Description
cold-processed VCO
Primary Outcome Measure Information:
Title
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.
Title
Change in Oxidative Stress Markers
Description
The oxidative stress markers consist of Malondialdehyde (MDA), Superoxide Dismutase (SOD), and Glutathione (GSH) levels.
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.
Secondary Outcome Measure Information:
Title
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.
Title
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.
Other Pre-specified Outcome Measures:
Title
Adverse events
Time Frame
Adverse events will be noted every 4 weeks from initial consult for a total of 24 weeks.
Title
Patients' assessment of VCO
Description
The following characteristics of VCO will be noted: taste/palatability, smell, ease of ingestion, efficacy, and degree of compliance.
Time Frame
At the 24th week (on final follow-up), the patients in group 2 will be asked to answer the VCO assessment questionnaire.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Philippine General Hospital
City
Manila
ZIP/Postal Code
1000
Country
Philippines

12. IPD Sharing Statement

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Virgin Coconut Oil Oral Supplementation for Leprosy Patients

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