Role of Vitamin D in Prevention of Dengue Haemorrhagic Fever and Dengue Shock Syndrome
Status:
Recruiting
Trial end date:
2024-02-15
Target enrollment:
Participant gender:
Summary
Dengue is an arthropod-borne disease, found in tropical and sub-tropical climates worldwide,
mostly in urban and semi-urban areas. Unfortunately, there is no intervention available to
stop dengue severity. Despite significant efforts into developing vaccine and antiviral drug
for dengue fever over the years, numerous challenges remain before an efficient, safe vaccine
and antiviral drug. Dengue Haemorrhagic Fever (DHF) and Dengue Shock Syndrome (DSS) are a
serious form of dengue infection that can escalate in a non-negligible percentage of febrile
patients. Factors responsible for this deterioration are weakly understood. The host's
genetics and secondary infections from novel dengue serotypes are obvious risk factors. The
dietary state of the host has also been emphasized as a potentially important predictor of
progression because some nutrients have potent immunomodulatory effects. Vitamin D is
particularly important as it has ability to control immunological processes, including the
downregulation of pro-inflammatory Th1 activity, which has been linked to the pathophysiology
of severe dengue. There is a preliminary study regarding the effectiveness of vitamin D in
the prevention of DHF and DSS in human. But a larger study is needed to prove its utility.
The objective of the study is to determine the role of Vitamin D in efficacy, safety and dose
response in the prevention of DHF and DSS. This will be an open-label Phase-2 Randomized
controlled trial (RCT) which will be carried out in Dengue cell, Emergency Department and
Outpatient Department (OPD) of Medicine Department in Bangabandhu Sheikh Mujib Medical
University, Dhaka. It will be conducted from September 2023 to August 2024 enrolling about
120 patients from Dengue cell, Emergency Department and OPD of Medicine Department BSMMU. The
duration of the study will be one year. All the investigations will be done in BSMMU.
Patients will be followed up by phone call and physical visit. Those with severe symptoms
will be admitted and evaluated accordingly. The study will have three arms namely, Arm
1(receiving standard care), Arm 2(receiving standard care and 2,00,000 IU Vitamin D oral
solution) and Arm 3(receiving standard treatment and 4,00,000 IU Vitamin D oral solution).
The patients will be enrolled according to inclusion criteria (having age more than 18 to
65years, NS1 positive, fever more than ≥38°C for 3days or less, typical sign symptoms of
Dengue fever) and exclusion criteria (>72hours of fever, critically ill patients, pregnancy,
known Vitamin D hypersensitivity, high serum calcium level, hypoalbuminaemia, malignancy,
known nephrolithiasis and severe renal impairment). Information will be obtained on
socio-demographic and clinical characteristics through face to face interview using a
structured questionnaire. Clinical data and relevant blood samples will be taken at first
appointment then after 4th day and 8th day of enrollment. This study has minimal chance of
physical risks. Study purpose will be explained to the participants and informed written
consent will be taken before collection of data. Data will be collected with assurance of
proper safety and privacy. The interventional drug, vitamin D3 is a widely used agent with
rare minimal side effects like, vomiting, abdominal pain, headache, constipation etc. Each
participant will be counselled about the outcome of the drug and will be followed up and
managed for potential side effects. Participants will be identified by a code number, strict
confidentiality and anonymity will be maintained. There will be no loss of work time and no
compensation will be available for the participants as this will be a part of standard care.
On the other hand, this study would be helpful for both the clinician and the patients in
making a rational approach in Group A Dengue fever for the prevention of DHF and DSS. Prior
to the commencement of this study, the research protocol will take approval from Research and
Training Monitoring Department(RTMD) of BCPS. The analyzed data will be presented in the form
of text, tables, and graphs. Finally collected data will be analyzed by graph pad prism.
Statistical analysis will be performed by Chi-square test on categorical data and one way
ANOVA with Tukey's multiple comparisons test on continuous data. Kaplan-Meier Curve will be
used to study the progression into DHF and DSS. This study, for the first time in Bangladesh,
will obtain the baseline data regarding the utility of Vitamin D therapy in Dengue
uncomplicated cases in preventing further deterioration of clinical severity and mortality.
This trial will help clinicians and policy makers to avail a possible repurposing of Vitamin
D for prevention of severe dengue. In addition, it will guide designing larger study to
generate strong evidence and change the national health response accordingly.
Phase:
Phase 2
Details
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins