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Home » Trials » SLCTR/2017/028

Effectiveness of Vitamin C in reducing morbidity in patients with Dengue fever - A double blinded randomized placebo controlled pilot study.

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SLCTR Registration Number

SLCTR/2017/028

Date of Registration

30 Aug 2017

The date of last modification

Mar 03, 2019


Application Summary

Scientific Title of Trial

Effectiveness of Vitamin C in reducing morbidity in patients with Dengue fever - A double blinded randomized placebo controlled pilot study.

Public Title of Trial

Effectiveness of Vitamin C in reducing morbidity in patients with Dengue fever - A double blinded randomized placebo controlled pilot study.

Disease or Health Condition(s) Studied

Dengue fever

Scientific Acronym

VITCDEN (vitamin C in Dengue infection)

Public Acronym

VITCDEN (vitamin C in Dengue infection)

Brief title

Vitamin C in dengue fever

Universal Trial Number

U1111-1199-3246

Any other number(s) assigned to the trial and issuing authority

03.05.2017:4.4 (ERC, Ruhuna)


Trial Details

What is the research question being addressed?

Is Vitamin C effective in reducing morbidity in patients with Dengue fever?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Double blinded

Control

Placebo

Assignment

Parallel

Purpose

Treatment

Study Phase

Phase 2

Intervention(s) planned

The study will be carried out in the medical wards of the Teaching Hospital, Karapitiya, Sri Lanka. Patients will be randomized using simple randomization.

Those in the treatment arm would receive oral liposomal vitamin C 1000mg bid (twice daily) for 5 days and the control arm would receive a matching placebo for the same duration.

Following investigations will be done in both arms, full blood count (twice daily) Liver enzymes (daily) CRP (at least twice during hospital stay) Dengue serotypes Dengue IgG, IgM antibodies at day 5 or 6 TNF (once during the hospital stay) IL-6 (once during the hospital stay) Ultrasound scan (daily- to look for any evidence of leakage).

Both arms will receive standard care which will include observation, symptomatic treatment including paracetamol for fever and domperidone for vomiting and management of complications of dengue infection (i.e. iv fluid bolus, dextran or blood transfusion depending on the type of complication).

Participants, health care providers, data collectors, outcome adjudicators, data analysts will be blinded to the therapy received.

Inclusion criteria

  1. Male and female patients aged 12-70 years.
  2. Previously healthy patients coming with dengue fever
  3. Within the first 3 days of fever
  4. Positive NS1 dengue antigen
  5. Platelet count more than 100 000/mm3

Exclusion criteria

  1. Patients under age of 12 years and above 70 years
  2. Those who have any evidence of plasma leakage, shock or impeding shock, fluid overload, internal bleeding at that time of recruitment
  3. Those who have severe vomiting or inability to take oral fluids
  4. Drowsy patients - Drowsiness will be assessed clinically based on appearance followed by glasgow coma scale.
  5. Those who have liver failure with clinical or biochemical evidence
  6. Those who have AST or ALT more than 100 IU/L on admission
  7. Patients with other co-morbidities such as diabetes mellitus, hypertension, ischemic heart disease, bronchial asthma, thyroid disorders etc.
  8. Patients who are on other medication (statins, metformin, beta blockers)
  9. Patients who are severely dehydrated
  10. Patients who get admitted later (more than 3 days after onset of fever)
  11. Patients who are extremely obese,- BMI more than 27 kg/m2
  12. Patients with known fatty liver disease
  13. Patients who have used any alternative medicine eg:- indigenous medicine
  14. Patients with diagnosed mental illness
  15. Patients with ongoing other infections, malignancy

Primary outcome(s)

1.

Number of days need to be hospitalised.

 [

Daily during hospital stay

]
2.

Number of patients going into leaking phase

 [

Daily during hospital stay

]
3.

Secondary bacterial infection

 [

Daily during hospital stay

]

Secondary outcome(s)

1.

None

 [

None

]

Target number/sample size

60 (30 in each arm)

Countries of recruitment

Sri Lanka

Anticipated start date

2017-09-01

Anticipated end date

2017-11-30

Date of first enrollment

2017-09-03

Date of study completion

Recruitment status

Recruiting

Funding source

LivOn Labs, USA

Regulatory approvals

Not applicable


State of Ethics Review Approval

Status

Approved

Date of Approval

2018-06-14

Approval number

03.05.2017:4.4

Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Ruhuna
Institutional Address:PO Box 70, Labuduwa Rd, Galle, Sri Lanka
Telephone:+94-91-2234801/803 (Extension: 161)
Email: ethics@med.ruh.ac.lk

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr. H M M Herath
Senior Lecturer in Clinical Medicine, Consultant Physician
Faculty of Medicine, University of Ruhuna, Galle, Sri Lanka
Tel: +94912234803
Mob: 0773453217

herathtp@gmail.com

Contact Person for Public Queries

Dr. H M M Herath
Senior Lecturer in Clinical Medicine, Consultant Physician
Faculty of Medicine, University of Ruhuna, Galle, Sri Lanka
Tel: +94912234803
Mob: 0773453217

herathtp@gmail.com

Primary study sponsor/organization

Jonathan Orchard BSc(Hons) MBAcC
Director- LivOn Labs
2654W Horizon Ridge Pkwy B5- 108, Henderson, NV 89052, USA
+1 (702) 9365910 +447786233317

jonathan@abundanceandhealth.co.uk

Secondary study sponsor (If any)

None





Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Not Available

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

No

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results


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