A Randomized Trial of Vitamin D to Reduce Respiratory Infection

McMaster University

Status: Completed

Conditions: Respiratory Infection

Treatments: Dietary Supplement: vitamin D supplements; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01705314

VitD2012

Details and patient eligibility

About

The goal of this study is to assess the effectiveness of vitamin D in reducing laboratory-confirmed influenza and in reducing non-influenza viral respiratory tract infections. A cohort of children between the ages of 3 and 17 years from the Thanh Ha Commune, Thanh Liem District, Ha Nam Province, Vietnam will be randomized to either weekly vitamin D supplements or placebo. Participants who develop acute respiratory infection over a 12-month period, will be tested for influenza, the co-primary outcome, and other respiratory viruses, the other co-primary outcome, by RT-PCR.

Enrollment: 1,300 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Between the ages of 3 and 17
• Residing in Thanh Liem District, Ha Nam Province, Vietnam

Exclusion criteria

• Born prematurely at less than 32 weeks gestation
• Any chronic illness (except asthma)
• Currently using medication known to interfere with vitamin D metabolism
• Children with a sibling participating in the study

Trial design

1,300 participants in 2 patient groups, including a placebo group

vitamin D supplements

Experimental group

Description:

children and adolescents that are randomized to the intervention will receive 7 mls of D-drops (14,000U/week of vitamin D) for eight months

Treatment:

Dietary Supplement: vitamin D supplements

vitamin D placebo

Placebo Comparator group

Description:

children and adolescents that are randomized to placebo will receive 7 mls of placebo drops for eight months

Treatment:

Dietary Supplement: placebo