Virgin Coconut Oil Oral Supplementation for Leprosy Patients
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| ClinicalTrials.gov Identifier: NCT01885611 |
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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Withdrawn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
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hansen's Disease | Other: Multi-Drug Therapy (Novartis Ⓡ) Dietary Supplement: Virgin Coconut Oil | Phase 1 Phase 2 |
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 (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Supportive Care |
| 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 Start Date : | June 2013 |
| Estimated Primary Completion Date : | December 2017 |
| Estimated Study Completion Date : | June 2018 |
| Arm | Intervention/treatment |
|---|---|
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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 Name: MDT |
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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 Name: MDT Dietary Supplement: Virgin Coconut Oil cold-processed VCO
Other Name: VCO |
- 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.
- 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. ]
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885611
| Philippines | |
| Philippine General Hospital | |
| Manila, Philippines, 1000 | |
| Responsible Party: | Carmela Dayrit, MD, Philippine Dermatological Society |
| ClinicalTrials.gov Identifier: | NCT01885611 History of Changes |
| Other Study ID Numbers: |
PDS_PGH_2013_003 UPMREB MED-2013-P3-053 ( Registry Identifier: University of the Philippines, Manila Research Ethics Board ) |
| First Posted: | June 25, 2013 Key Record Dates |
| Last Update Posted: | April 5, 2017 |
| Last Verified: | April 2017 |
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Leprosy |
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Leprosy Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Rifampin Dapsone Clofazimine Lactitol Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Leprostatic Agents Nucleic Acid Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP2C8 Inducers Cytochrome P-450 CYP2C19 Inducers Cytochrome P-450 CYP2C9 Inducers Cytochrome P-450 CYP3A Inducers Cathartics Gastrointestinal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Anti-Inflammatory Agents |