Zinc supplement for Dengue fever

• Register: TCTR
• Last refreshed on: 29 April 2024
• Main ID: TCTR20151110001
• Date of registration: 10/11/2015
• Prospective Registration: Yes
• Primary sponsor: Srinakharinwirot University
• Public title: Zinc supplement for Dengue fever
• Scientific title: A randomized controlled trial of zinc supplementation for regulation severity of dengue viral infection in children
• Date of first enrolment: 01/01/2016
• Recruitment status: Recruiting
• URL: https://www.thaiclinicaltrials.org/show/TCTR20151110001
• Study type: Interventional
• Study design: Randomized
• Phase: Phase 2/Phase 3

Countries of recruitment

Thailand

Contacts

• Name: Sanguansak Rerksuppaphol
• Affiliation: Srinakharinwirot University

• Name: Sanguansak Rerksuppaphol
• Affiliation: Srinakharinwirot University

Key inclusion & exclusion criteria

Inclusion criteria: children with fever and 2 of the following criteria: 1) nausea, vomiting 2) rash 3) aches and pain 4) Touniquet test positive 5) Leukopenia 6) any warning sign (adbominal pain or tenderness, persistent vomiting, clinical fluid accumulation, mucosal bleeding, lethargy or restlessness, liver enlargment >2 cm, increase in HCT concurrent with rapid decrease in platelet count
Exclusion criteria: children already taking vitamin or minerals regularly or having allergy to them will be excluded. Children with known history of chronic systemic illness will also be excluded.

Age minimum: 1 Years
Age maximum: 15 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Child, dietary supplements, dengue, zinc

Dengue cases as per WHO classification (2009)
Child, dietary supplements, dengue, zinc

Intervention(s)

Children in treatment group will be given chelated zinc in form of zinc bis-glycinate (15 mg elemental zinc) 3 times a day for 5 days or until convalescence of fever.,Children in placebo group will receive ORS based placebo which is prepared by the same manufacturer and is in identical package of active comparator.

zinc,placebo

Active Comparator Dietary Supplement,Placebo Comparator No treatment

Primary Outcome(s)

recovery time at the end of study day of covalescence of fever

Secondary Outcome(s)

plasma zinc levels 72 hours direct mesure of plasma zinc

Source(s) of Monetary Support

Srinakharinwirot University

Secondary Sponsor(s)

Srinakharinwirot University

Ethics review

Status: Submitted, pending
Approval date:
Contact:

Srinakharinwirot University Ethics committee

Results

• Date Completed: 30/04/2017