Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 5 for:    "Hansen's Disease" | "Vitamin B9"
Previous Study | Return to List | Next Study

Virgin Coconut Oil Oral Supplementation for Leprosy Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01885611
Recruitment Status : Withdrawn (There was a problem with funding and with the acquisition of the lab assays)
First Posted : June 25, 2013
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Carmela Dayrit, Philippine Dermatological Society

Tracking Information
First Submitted Date  ICMJE June 14, 2013
First Posted Date  ICMJE June 25, 2013
Last Update Posted Date April 5, 2017
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2013)
  • 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. ]
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01885611 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2013)
  • 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. ]
  • 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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 20, 2013)
  • Adverse events [ Time Frame: 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Virgin Coconut Oil Oral Supplementation for Leprosy Patients
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Hansen's Disease
Intervention  ICMJE
  • 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 Name: MDT
  • Dietary Supplement: Virgin Coconut Oil
    cold-processed VCO
    Other Name: VCO
Study Arms  ICMJE
  • 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)

    Intervention: Other: Multi-Drug Therapy (Novartis Ⓡ)
  • 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)

    Interventions:
    • Other: Multi-Drug Therapy (Novartis Ⓡ)
    • Dietary Supplement: Virgin Coconut Oil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 3, 2017)
0
Original Actual Enrollment  ICMJE
 (submitted: June 20, 2013)
26
Estimated Study Completion Date  ICMJE June 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Philippines
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01885611
Other Study ID Numbers  ICMJE PDS_PGH_2013_003
UPMREB MED-2013-P3-053 ( Registry Identifier: University of the Philippines, Manila Research Ethics Board )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carmela Dayrit, Philippine Dermatological Society
Study Sponsor  ICMJE Philippine Dermatological Society
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Philippine Dermatological Society
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP