Recruitment

Recruitment Status
Completed

Inclusion Criterias

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

Exclusion Criterias

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

Summary

Conditions
Acute Respiratory Tract Infections
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Prevention

Participation Requirements

Age
Younger than 1836 years
Gender
Both males and females

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. Chil...

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.

Inclusion Criterias

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

Exclusion Criterias

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

Locations

Santiago, Región Metropolitana
Talcahuano, VIII Región
Punta Arenas, Magallanes
Santiago, Región Metropolitana
Talcahuano, VIII Región
Punta Arenas, Magallanes

Tracking Information

NCT #
NCT02046577
Collaborators
  • National Fund for Research and Development in Health, Chile
  • Laboratorio Pasteur
Investigators
  • Principal Investigator: María L Reyes, M.D. Pontificia Universidad Catolica de Chile Study Director: Cecilia Vizcaya, M.D. Pontificia Universidad Catolica de Chile Study Director: Arturo Borzutzky, M.D. Pontificia Universidad Catolica de Chile Study Director: Catalina Le Roy, M.D. Pontificia Universidad Catolica de Chile Study Director: Carlos A. Camargo Jr., M.D. Dr.PH. Massachusetts General Hospital, Harvard University Study Director: Karin Brikmann, M.D. Hospital Regional de Punta Arenas Study Director: Flavia Chamorro, M.D. Hospital de Coyhaique Study Director: Marco Reyes, M.D. Hospital de Coyhaique Study Director: Carolina Loureiro, M.D. Pontificia Universidad Catolica de Chile
  • María L Reyes, M.D. Pontificia Universidad Catolica de Chile Study Director: Cecilia Vizcaya, M.D. Pontificia Universidad Catolica de Chile Study Director: Arturo Borzutzky, M.D. Pontificia Universidad Catolica de Chile Study Director: Catalina Le Roy, M.D. Pontificia Universidad Catolica de Chile Study Director: Carlos A. Camargo Jr., M.D. Dr.PH. Massachusetts General Hospital, Harvard University Study Director: Karin Brikmann, M.D. Hospital Regional de Punta Arenas Study Director: Flavia Chamorro, M.D. Hospital de Coyhaique Study Director: Marco Reyes, M.D. Hospital de Coyhaique Study Director: Carolina Loureiro, M.D. Pontificia Universidad Catolica de Chile