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

NCT05034809 | Unknown Phase 2 DMC

• 1 other identifier: ITRMC-REC-2020-045
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dengue Fever With Warning Signs

Outcome Measures

Primary Outcomes (1)

• Number Of Days Prior To Elevation of Platelet Count Among Dengue Fever with Warningn Signs Patient Given Melatonin 20mg.

  Effectiveness Of Melatonin Tablet As An Adjunctive Therapy In Decreasing Morbidity For Pediatric Patients Diagnosed With Dengue Fever With Warning Signs

  1 year

Secondary Outcomes (3)

• Incidence Of Dengue Fever with Warning Signs among Pediatric Population at Ilocos Training and Regional Medical Center.

  1 year

• determine the effectiveness of Melatonin 20mg as adjunctive therapy for pediatric patients diagnosed with Dengue Fever with Warning Signs

  1 year

• Number Of Days Prior To Elevation of White Blood Cells Among Dengue Fever with Warningn Signs Patient Given Melatonin 20mg.

  1 year

Study Arms (2)

Treatment Group

EXPERIMENTAL

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.

Drug: Melatonin 20 MG

Control Group

NO INTERVENTION

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.

Interventions

Melatonin 20 MG 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.

Treatment Group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. Patient aged 5 to 18 years old with febrile episodes (Temperature \>/= 37.8 degrees Celsius) with positive Dengue NS1.
• \. Patients with Dengue Fever on the Department of Health 2012 definition of Dengue fever with Warning Signs with any one of the following:
• Abdominal tenderness
• Persistent vomiting
• Minimal mucosal bleed
• Platelet count less than or equal to 100,000

You may not qualify if:

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

Sponsors & Collaborators

• Ilocos Training and Regional Medical Center: lead

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Ma. Lydia O Ramirez, MD

  Ilocos Training and Regional Medical Center

  STUDY CHAIR

Central Study Contacts

Navid P Roodaki, MD

CONTACT

+63 917 309 3931; navidroodaki2391@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The research assistant will explain to the parents and to the child if capable of understanding the clinical trial. However, the participants, family and the researcher will not know until the end of the study if they were placed in the control group or treatment group. Blinding will be done using a pre-generated number code and QR code which, when scanned by the research assistant at the end of the study, it will reveal to what group the patient was randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Chief Resident

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: September 5, 2021
• Study Start: October 20, 2021
• Primary Completion: August 30, 2022
• Study Completion: October 30, 2022
• Last Updated: October 13, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share