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Completed

NCT Number: NCT02046577

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

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.

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Key information

Age range

18 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Las Higueras, Talcahuano, Biobio, Chile

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D3

Dietary Supplement

Cholecalciferol administration

Other names: Cholecalciferol

Placebo

Dietary Supplement

Placebo liquid

Primary outcomes

  1. Incidence of acute respiratory tract infections

    Time frame: 6 months

Secondary outcomes

  1. Adverse events

    Time frame: 6 months

  2. Hospitalizations due to acute respiratory tract infections

    Time frame: 6 months

  3. Serum cathelicidin levels

    Time frame: 6 months

    Baseline and after 6 months measurement of serum cathelicidin levels.

  4. serum 25-hydroxyvitamin D levels

    Time frame: 6 months

    Baseline and after 6 months measurement of serum 25-hydroxyvitamin D levels.

  5. Viral etiology of ARTIs

    Time frame: 6 months

    Specific virological etiology of ARTIs will be evaluated by polymerase chain reaction in children with febrile ARTIs and with medical diagnosis of bronchiolitis or pneumonia.

  6. Bone metabolism parameters

    Time frame: 6 months

    Baseline and after 6 months measurement of serum parathormone (PTH), alkaline phosphatases, calcium, phosphorus, and urinary calcium/creatinine ratio.

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Collaborators

  • Laboratorio Pasteur
  • National Fund for Research and Development in Health, Chile

Registry information

Official study title

A Randomized, Double-blind, Controlled Trial of Vitamin D for the Prevention of Acute Respiratory Infections in Children Aged 18 to 36 Months in Santiago, Coyhaique and Punta Arenas, Chile

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jan 28, 2014
Registry last updated
Oct 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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