Study of Vitamin D for the Prevention of Acute Respiratory Infections in Children

Pontificia Universidad Catolica de Chile

Status and phase: Completed; Phase 2

Conditions: Acute Respiratory Tract Infections

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT02046577

13-116

Fonis SA13I20173 (Other Grant/Funding Number)

Details and patient eligibility

About

The main purpose of this study is to determine whether weekly oral vitamin D supplementation is effective to prevent acute respiratory tract infections in children. The hypothesis of the study is that vitamin D supplementation reduces the incidence and severity of acute respiratory tract infections in children.

Full description

Acute respiratory tract infections (ARTIs) are associated with high levels of morbidity and socioeconomic impact, particularly affecting young children. Observational studies have shown an association between vitamin D (VD) deficiency and higher incidence and severity of respiratory infections. Chile has a high prevalence of VD deficiency, particularly in the southern regions of the country. The objective of this study is to evaluate the safety and efficacy of oral VD supplementation to decrease the incidence of ARTIs in 275 preschool children. A randomized, placebo-controlled, double-blind study will be performed in Santiago, Coyhaique and Punta Arenas. Children aged 18 to 36 months will be given weekly oral 5600 IU of vitamin D3 (VD3), 11200 IU of VD3, or placebo doses during 6 months.

Enrollment: 276 patients

Sex: All

Ages: 18 to 36 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children aged 18 to 36 months attending daycare in Santiago, Coyhaique or Punta Arenas.

Exclusion criteria

• History of chronic illness requiring immunosuppression
• History of metabolic bone disease
• Use of vitamin D supplementation greater than 400 IU daily, either by milk formula or vitamin supplements in the last 3 months.
• Use of fish oil supplements in the last 3 months.
• Immunodeficiency
• Planned trip to sunny climate during study period.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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276 participants in 3 patient groups, including a placebo group

5600 IU Vitamin D3

Experimental group

Description:

Oral 5600 IU Vitamin D3 in liquid weekly during 6 months

Treatment:

Dietary Supplement: Vitamin D3

Oral 11200 IU Vitamin D3 weekly

Experimental group

Description:

Oral 11200 IU Vitamin D3 in liquid weekly during 6 months

Treatment:

Dietary Supplement: Vitamin D3

Placebo

Placebo Comparator group

Description:

Oral placebo in liquid weekly during 6 months

Treatment:

Dietary Supplement: Placebo