| CTRI Number |
CTRI/2025/11/098229 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
26/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of serum Ferritin levels in Dengue patients |
|
Scientific Title of Study
|
Study of serum ferritin levels in Dengue patients and its correlation with severity of Dengue virus infection |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ainala Venkatadri Reddy |
| Designation |
Junior Resident |
| Affiliation |
D Y Patil Hospital |
| Address |
General Medicine Department, D Y Patil Hospital, Nerul, Navi Mumbai, 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9440930232 |
| Fax |
|
| Email |
venkatadrireddy048@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saurabh Kothari |
| Designation |
|
| Affiliation |
D Y Patil Hospital |
| Address |
General Medicine Department, D Y Patil Hospital, Nerul, Navi Mumbai, 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9552772777 |
| Fax |
|
| Email |
saurabhkothari77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ainala Venkatadri Reddy |
| Designation |
Junior Resident |
| Affiliation |
D Y Patil Hospital |
| Address |
General Medicine Department, D Y Patil Hospital, Nerul, Navi Mumbai, 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9440930232 |
| Fax |
|
| Email |
venkatadrireddy048@gmail.com |
|
|
Source of Monetary or Material Support
|
| General Medicine Department, D Y Patil Hospital, Nerul, Navi Mumbai, 400706 |
|
|
Primary Sponsor
|
| Name |
Ainala Venkatadri Reddy |
| Address |
General Medicine Department, D Y Patil Hospital, Nerul, Navi Mumbai, 400706 |
| Type of Sponsor |
Other [Private Deemed University] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ainala Venkatadri Reddy |
D Y Patil Hospital |
Dept of General Medicine, Nerul, Navi Mumbai
Thane
MAHARASHTRA |
9440930232
venkatadrireddy048@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B338||Other specified viral diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Both genders.
Any patient older than 18 years with a history of fever with a dengue
positive profile (NS1 antigen and IgM antibody positive) by SD BIOLINE RDT. |
|
| ExclusionCriteria |
| Details |
All cases that involved anemia, chronic inflammatory disease, and a recent
blood transfusion. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Measure and compare serum ferritin levels in dengue patients at different stages of
disease. Determine if there’s a correlation between ferritin levels and the severity of dengue. Evaluate the potential of serum ferritin as a biomarker for predicting severe dengue or
complications. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aedes aegypti and Aedes albopictus mosquitoes transmit dengue, a significant
viral infection and health concern globally . The World Health Organization (WHO)
reports nearly 50-100 million new infections annually, with 50,000 severe cases
requiring hospitalization and a mortality rate of 2.5percent. The number of cases has
surged nearly eight-fold from 505,430 in 2000 to about 5.2 million in 2019. In 2012,
WHO labeled dengue as the most significant viral disease spread by mosquitoes.
In some rural regions of India, dengue fever has a case fatality rate of 3-5percent. Although
it can be managed with simple and inexpensive treatments, the disease can become
life-threatening if not diagnosed early. Dengue is known for causing substantial cytokine
activation. The four different serotypes of the dengue virus (DV I to IV) can induce
symptoms ranging from asymptomatic infection to severe dengue. Dengue fever is
suspected when a febrile illness lasting two to seven days includes two or more
symptoms such as headache, retro-orbital pain, muscle pain, joint pain, rash, and
hemorrhagic presentation. For the first five days of fever, dengue is diagnosed using
the NS1 antigen reactivity by enzyme-linked immunosorbent assay (ELISA), which has
a diagnostic sensitivity of over 90percent within two to three days of illness onset but
decreases significantly after the fifth day. Dengue virus-specific IgM can also be
used for diagnosis, with a sensitivity that increases to 50percent after three to five days, 80percent after more than five days, and 100percent after 10 days in individuals who have never been
infected with dengue virus .
Severe dengue is classified by WHO as dengue hemorrhagic fever and dengue
shock syndrome . Since there is no specific treatment for severe dengue, early
detection and proper medical care can reduce the fatality rate to below 1percent. To predict
severity, several biomarkers for immunological and endothelial cell activity have been
established . Dengue infection leads to an increase in acute phase reactants like
alpha1 antitrypsin, ceruloplasmin, and ferritin. Ferritin, an iron storage protein complex
produced by the reticuloendothelial system, rises in response to infection as the body
deprives bacteria of serum iron. Hyperferritinemia, or elevated serum ferritin levels,
in dengue patients is associated with severe immunological activation and coagulation
issues. Studies have shown that lower serum ferritin levels correlate with better
9
outcomes, and elevated levels are linked to severe dengue fever in children. In a
study of 177 children, serum ferritin levels were measured throughout their clinical
course, and it was found that levels greater than or equal to 1,200 ng per mL may predict
dengue hemorrhagic fever.
A study conducted on Aruba Island during a dengue outbreak reported that ferritin
can be an effective clinical marker for differentiating dengue from other febrile diseases. Serum ferritin levels exceeding 1,500 ng per mL were associated with severe illness.
Therefore, it is vital to constantly monitor patients with hyperferritinemia, as it is linked
to significant immunological activation and coagulation issues .
It is critical to forecast the risk of severe dengue fever early using basic quantifiable
tests, so that necessary, intensive supportive care can be initiated promptly. Our study
aimed to determine if serum ferritin measured during the early course of the disease
can predict dengue severity, aiding in appropriate triage and management. Additionally,
the study aimed to examine the correlation between serum ferritin levels and the
duration of hospital stay. 1. Study site Department of General Medicine, Dr DY Patil hospital.
2. Study population: Patients attending OPD and IPD of Department of
Medicine. |