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

Sponsor

Pontificia Universidad Catolica de Chile (Other)

Overall Status

Completed

CT.gov ID

NCT02046577

Collaborator

National Fund for Research and Development in Health, Chile (Other), Laboratorio Pasteur (Other)

276

Enrollment

Locations

Arms

26.9

Duration (Months)

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Tract Infections	Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

276 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official 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

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 5600 IU Vitamin D3 Oral 5600 IU Vitamin D3 in liquid weekly during 6 months	Dietary Supplement: Vitamin D3 Cholecalciferol administration Other Names: Cholecalciferol
Experimental: Oral 11200 IU Vitamin D3 weekly Oral 11200 IU Vitamin D3 in liquid weekly during 6 months	Dietary Supplement: Vitamin D3 Cholecalciferol administration Other Names: Cholecalciferol
Placebo Comparator: Placebo Oral placebo in liquid weekly during 6 months	Dietary Supplement: Placebo Placebo liquid

Arm

Intervention/Treatment

Experimental: 5600 IU Vitamin D3

Oral 5600 IU Vitamin D3 in liquid weekly during 6 months

Dietary Supplement: Vitamin D3

Cholecalciferol administration

Other Names:

Cholecalciferol

Experimental: Oral 11200 IU Vitamin D3 weekly

Oral 11200 IU Vitamin D3 in liquid weekly during 6 months

Dietary Supplement: Vitamin D3

Cholecalciferol administration

Other Names:

Cholecalciferol

Placebo Comparator: Placebo

Oral placebo in liquid weekly during 6 months

Dietary Supplement: Placebo

Placebo liquid

Outcome Measures

Primary Outcome Measures

Incidence of acute respiratory tract infections [6 months]

Secondary Outcome Measures

Adverse events [6 months]
Hospitalizations due to acute respiratory tract infections [6 months]
Serum cathelicidin levels [6 months]
Baseline and after 6 months measurement of serum cathelicidin levels.
serum 25-hydroxyvitamin D levels [6 months]
Baseline and after 6 months measurement of serum 25-hydroxyvitamin D levels.
Viral etiology of ARTIs [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.
Bone metabolism parameters [6 months]
Baseline and after 6 months measurement of serum parathormone (PTH), alkaline phosphatases, calcium, phosphorus, and urinary calcium/creatinine ratio.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months to 36 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Hospital de Punta Arenas	Punta Arenas	Magallanes	Chile
2	Pontificia Universidad Católica de Chile	Santiago	Región Metropolitana	Chile
3	Hospital Las Higueras	Talcahuano	VIII Región	Chile

Sponsors and Collaborators

Pontificia Universidad Catolica de Chile
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