Efficacy of vitamin A supplementation for prevention and severity reduction of hand-foot-mouth disease in young childre

Phase 3

Not yet recruiting

• Conditions: Hand- Foot- Mouth Disease; Hand, Foot and Mouth Disease; Enterovirus; Vitamin A; clinical trials, randomized

• Registration Number: TCTR20191002003
• Lead Sponsor: ational Research Council of Thailand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-02
• Study Completion: 2020-07-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

1. Preschool children ages 1-6years attending participating childcare centers/kindergarten.
2. Parents or guardians consent to participate.

Exclusion Criteria

1. Taking vitamin A supplementation within one month prior to enrollement.
2. Known to be HIV-infected.
3. Having had Hand Foot Mouth Disease within one month prior to enrollement

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence and severity of Hand Foot Mouth Disease 1 year Incidence

Secondary Outcome Measures

Name	Time	Method
Size of outbreaks of HFMD in childcare centers/kindergartens in treatment versus control arms. 1 year Incidence of outbreak,Association of low serum vitamin A level and severity of HFMD in both arms 1 year Odds ratio