Virgin Coconut Oil Oral Supplementation for Leprosy Patients

NCT01885611 | Withdrawn Phase 1 DMC

• 2 other identifiers: PDS_PGH_2013_003UPMREB MED-2013-P3-053
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hansen's Disease

Keywords

Leprosy

Outcome Measures

Primary Outcomes (2)

• Change in Bacterial Indices

  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.

  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)

  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

  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 Outcomes (2)

• Adverse events

  Adverse events will be noted every 4 weeks from initial consult for a total of 24 weeks.

• Patients' assessment of VCO

  At the 24th week (on final follow-up), the patients in group 2 will be asked to answer the VCO assessment questionnaire.

Study Arms (2)

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)

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)

Other: Multi-Drug Therapy (Novartis Ⓡ); Dietary Supplement: Virgin Coconut Oil

Interventions

Multi-Drug Therapy (Novartis Ⓡ) 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).

Also known as: MDT

Multi-Drug Therapy (Novartis Ⓡ); Virgin Coconut Oil (VCO) with MDT

Virgin Coconut Oil DIETARY_SUPPLEMENT

cold-processed VCO

Also known as: VCO

Virgin Coconut Oil (VCO) with MDT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philippine Dermatological Society: lead

Study Sites (1)

Philippine General Hospital

Manila, Manila, 1000, Philippines

Location

MeSH Terms

Conditions

Leprosy

Interventions

lactitol

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: June 25, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

PH (1)