Using Vitamin D to prevent severe dengue infections
Efficacy, Safety and Dose Response of Vitamin D in Prevention of Dengue Haemorrhagic Fever and Dengue Shock Syndrome- A Phase 2 Open-label Randomized Controlled Trial
This study is testing if high doses of Vitamin D can help prevent dengue fever from getting worse in adults who are showing symptoms of the illness.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh Academic / other |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT06071481 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the role of Vitamin D in preventing the progression of dengue fever to more severe forms, specifically Dengue Haemorrhagic Fever (DHF) and Dengue Shock Syndrome (DSS). Conducted in Bangladesh, a region heavily affected by dengue outbreaks, the study aims to assess the effects of high doses of Vitamin D3 administered orally to patients who are NS1 positive and exhibit typical symptoms of dengue fever. The trial will include participants aged 18 to 65 years and will monitor their response to the treatment over time. The goal is to determine if Vitamin D can modulate immune responses and reduce the severity of dengue infections.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 years who are NS1 positive and have had a fever for three days or less with typical dengue symptoms.
Not a fit: Patients who are critically ill, pregnant, or have known hypersensitivity to Vitamin D will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a simple and cost-effective intervention to reduce the severity and mortality associated with dengue infections.
How similar studies have performed: While the use of Vitamin D in infectious diseases is being explored, this specific approach to dengue prevention is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \>18 to 65 years. 2. NS1 positive people. 3. Fever ≥ 100.4°F (≥38°C) for 3days or less 4. Typical sign symptoms of Dengue fever. Exclusion Criteria: 1. \>72hours of fever. 2. Critically ill patients. 3. Pregnancy 4. Known Vitamin D hypersensitivity 5. High serum calcium level 6. Hypoalbuminaemia 7. Malignancy 8. Known nephrolithiasis and severe renal impairment.
Where this trial is running
Dhaka
- Bangabandhu Sheikh Mujib Medical University — Dhaka, Bangladesh (Recruiting)
Study contacts
- Study coordinator: Fazle R Chowdhury, FCPS; PhD
- Email: mastershakil@hotmail.com
- Phone: +88 01916578699
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.