Virgin Coconut Oil Oral Supplementation for Leprosy Patients

NCT ID: NCT01885611

Last Updated: 2017-04-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2018-06-30

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.

Conditions

Hansen's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Multi-Drug Therapy (Novartis Ⓡ)

Intervention Type: OTHER

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).

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)

Group Type: EXPERIMENTAL

Multi-Drug Therapy (Novartis Ⓡ)

Intervention Type: OTHER

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).

Virgin Coconut Oil

Intervention Type: DIETARY_SUPPLEMENT

cold-processed VCO

Interventions

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).

Intervention Type: OTHER

Virgin Coconut Oil

cold-processed VCO

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

MDT; VCO

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philippine Dermatological Society

NETWORK

Sponsor Role: lead

Responsible Party

Carmela Dayrit

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Philippine General Hospital

Manila, Manila, Philippines

Countries

Philippines

Other Identifiers

UPMREB MED-2013-P3-053

Identifier Type: REGISTRY

Identifier Source: secondary_id

PDS_PGH_2013_003

Identifier Type: -

Identifier Source: org_study_id