Effectiveness Of High Dose Melatonin As Adjunctive Therapy For Dengue Fever With Warning Signs

NCT ID: NCT05034809

Last Updated: 2021-10-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-20
• Study Completion Date: 2022-10-30

Brief Summary

Dengue Hemorrhagic Fever is a mosquito-borne viral disease endemic in the Philippines which caused multiple epidemics. Most points to the activation of the complement system secondary to humoral respond leading to cytokine release causing systemic inflammation. Melatonin, is a hormone which has an a) anti-viral, b) immunomodulator, c) antioxidant, d) modulatory effect on hematopoiesis and e) anti-inflammatory action.

This is a randomized control trial to determine the effectiveness of adjunctive melatonin therapy among patients diagnosed with Dengue fever with Warning Signs. This would include children aged 5 to 18 years old with no signs of hemmorhagic shock. They would be randomly assigned into 2 groups. Baseline Complete blood count with platelet (CBCPC) will be collected. Daily CBCPC will be collected and would be statistically analyze after the study.

Detailed Description

Dengue Hemorrhagic Fever is a mosquito-borne viral disease endemic in the Philippines which caused multiple epidemics. Most points to the activation of the complement system secondary to humoral respond leading to cytokine release causing systemic inflammation. Melatonin, is a hormone which has an a) anti-viral, b) immunomodulator, c) antioxidant, d) modulatory effect on hematopoiesis and e) anti-inflammatory action.

Main Objective:

To determine the effectiveness of Melatonin tablet as an adjunctive therapy in decreasing morbidity for pediatric patients diagnosed with Dengue Fever with Warning Signs at Ilocos Training and Regional Medical Center Department of Pediatrics.

Specific Objective

1. To determine the clinical profiles of pediatric patients diagnosed with Dengue Fever with Warning Signs in Ilocos Training and Regional Medical Center

2. To determine the effectiveness of Melatonin 20mg as adjunctive therapy for pediatric patients diagnosed with Dengue Fever with Warning Signs with regards to:

a. Number of days for resolution of fever from the 1st day of administration of melatonin b. Number of days for the platelet count to increase from the 1st day of administration of melatonin c. Number of days for the white blood cell count to increase from the 1st day of administration of melatonin d. Absence of subsequent complications in the critical phase of the illness (4th - 6th day of illness) i. Presence of mucosal bleeding, melena, epistaxis ii. Presence of ascites, pleural effusion, edema iii. Hypotension, tachycardia iv. Increase capillary refill time

Conditions

Dengue Fever With Warning Signs

Study Design

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

Study Groups

Treatment Group

Other than the guided management of Dengue Fever with warning signs, the treatment group will receive a standard dose of 20mg/day of melatonin20-21 for 5 days. The dosing was based on the study by Leiberman et al and Malhotra et al. If a patient is unable to tolerate the whole or punctured tablet, it will be given with milk or water. There is no known interaction between melatonin and milk known to date. Daily complete blood count will be done and be recording in an electronic record using Microsoft Excel.

Group Type: EXPERIMENTAL

Melatonin 20 MG

Intervention Type: DRUG

Melatonin, also known as N-acetyl-5-methoxytryptamine will be the main intervention given to participating patients of this study. This study will use a dose of 20mg/day using the commercially available 5mg/tablet20-21. If a patient cannot be tolerate swallowing the whole tablet, it will be crushed and mixed with milk. According to the study done by Shah et al. there was no degradation in the active component of melatonin when mixed with milk or food as a medium for drug delivery.

Control Group

Other than the guided management of Dengue Fever with warning signs, the control group will be manage according the Department of Health Dengue Management Guideline. No placebo will be given.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Melatonin 20 MG

Melatonin, also known as N-acetyl-5-methoxytryptamine will be the main intervention given to participating patients of this study. This study will use a dose of 20mg/day using the commercially available 5mg/tablet20-21. If a patient cannot be tolerate swallowing the whole tablet, it will be crushed and mixed with milk. According to the study done by Shah et al. there was no degradation in the active component of melatonin when mixed with milk or food as a medium for drug delivery.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1. Patient aged 5 to 18 years old with febrile episodes (Temperature >/= 37.8 degrees Celsius) with positive Dengue NS1.

2. Patients with Dengue Fever on the Department of Health 2012 definition of Dengue fever with Warning Signs with any one of the following:

1. Abdominal tenderness

2. Persistent vomiting

3. Minimal mucosal bleed

4. Platelet count less than or equal to 100,000

Exclusion Criteria

• 1. Patients with signs and symptoms related to dengue fever but with negative Dengue Ns1 result.

2. Patients diagnosed as Severe Dengue or Dengue Shock. 3. Patients unable to tolerate tablet formulation. 4. Patients placed on nothing per Orem. 5. Patients previously treated in a referring facility.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ilocos Training and Regional Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Navid Roodaki

Pediatric Chief Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ma. Lydia O Ramirez, MD

Role: STUDY_CHAIR

Ilocos Training and Regional Medical Center

Central Contacts

Navid P Roodaki, MD

Role: CONTACT

navidroodaki2391@gmail.com

+63 917 309 3931

Other Identifiers

ITRMC-REC-2020-045

Identifier Type: -

Identifier Source: org_study_id