Hansen's DiseasePhase 1/2NCT01885611
Virgin Coconut Oil Oral Supplementation for Leprosy Patients
A Phase 1/2 study testing Multi-Drug Therapy (Novartis Ⓡ) and Virgin Coconut Oil in people with Hansen's Disease, run by Philippine Dermatological Society at 1 site in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hansen's Disease
- What is being tested?
- Multi-Drug Therapy (Novartis Ⓡ) and Virgin Coconut Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 sitePhilippines
- Study dates
- Jun 2013to Jun 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Multi-Drug Therapy (Novartis Ⓡ), Virgin Coconut Oil
- Keywords
- Leprosy
- Medical subject headings
- Leprosy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Drug Therapy (Novartis Ⓡ)Other
Also called MDT
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 OilDietary supplement
Also called VCO
cold-processed VCO
| Study group | Role | What they receive |
|---|---|---|
| Multi-Drug Therapy (Novartis Ⓡ) | Active comparator | 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) Receives: Other: Multi-Drug Therapy (Novartis Ⓡ) |
| Virgin Coconut Oil (VCO) with MDT | Experimental | 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) Receives: Other: Multi-Drug Therapy (Novartis Ⓡ); Dietary Supplement: Virgin Coconut Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bacterial Indices
Measured: 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
The oxidative stress markers consist of Malondialdehyde (MDA), Superoxide Dismutase (SOD), and Glutathione (GSH) levels.
Measured: The oxidative stress markers will be measured in blood on initial consult, on the third month, and at the sixth month of treatment.
Secondary outcomes (2)
Change in Clinical Response Score (CRS)
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Why it stopped: There was a problem with funding and with the acquisition of the lab assays
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hansen's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philippine Dermatological Society
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Carmela Dayrit, Philippine Dermatological Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885611
- Sponsor's protocol ID
- PDS_PGH_2013_003
- Other IDs
- UPMREB MED-2013-P3-053
- Status last verified
- Apr 2017
- First submitted
- 14 Jun 2013
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01885611
- Acronym / sponsor ID
- PDS_PGH_2013_003
- Conditions
- Hansen's Disease
- Keywords
- Leprosy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: There was a problem with funding and with the acquisition of the lab assays
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Philippine Dermatological SocietyResearch network
- Study start
- Jun 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-Drug Therapy (Novartis Ⓡ) | Active comparator | Other: 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) |
| Virgin Coconut Oil (VCO) with MDT | Experimental | Other: Multi-Drug Therapy (Novartis Ⓡ), Dietary Supplement: Virgin Coconut OilVCO 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Drug Therapy (Novartis Ⓡ)Also: MDTThe 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 | Multi-Drug Therapy (Novartis Ⓡ), Virgin Coconut Oil (VCO) with MDT |
| Virgin Coconut OilAlso: VCOcold-processed VCO | Dietary supplement | Virgin Coconut Oil (VCO) with MDT |
Primary outcome
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.
2 secondary outcomes
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
Related trials for Hansen's Disease
Not yet recruitingPhase 2
Telacebec in Adults With Multibacillary Leprosy (TEBULA Leprosy Trial)
Leprosy, Multibacillary
RecruitingPhase 2
Efficacy and Safety Study of Dovramilast in People With Leprosy Type 2 Reaction
Erythema Nodosum Leprosum
RecruitingObservational study
Identification of Cutaneous and Blood Biomarkers Predictive of Response to Systemic Treatments During Chronic Inflammatory Skin Diseases
Atopic Dermatitis, Psoriasis
RecruitingPhase 3
Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy
Leprosy
Recruiting
Accuracy of the Polymerase Chain Reaction of Ulnar Perineural Subcutaneous Aspirate Guided by Ultrasound for the Diagnosis and Monitoring of Leprosy Cure
Leprosy, Leprosy Neuropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Multi-Drug Therapy (Novartis Ⓡ) and Virgin Coconut Oil in people with Hansen's Disease, run by Philippine Dermatological Society at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.