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| ID | Type | Description | Link |
|---|---|---|---|
| Fonis SA13I20173 | Other Grant/Funding Number | Fondo Nacional de Investigación y Desarrollo en Salud |
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| Name | Class |
|---|---|
| National Fund for Research and Development in Health, Chile | OTHER |
| Laboratorio Pasteur | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5600 IU Vitamin D3 | Experimental | Oral 5600 IU Vitamin D3 in liquid weekly during 6 months |
|
| Oral 11200 IU Vitamin D3 weekly | Experimental | Oral 11200 IU Vitamin D3 in liquid weekly during 6 months |
|
| Placebo | Placebo Comparator | Oral placebo in liquid weekly during 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Dietary Supplement | Cholecalciferol administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute respiratory tract infections | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 6 months | |
| Hospitalizations due to acute respiratory tract infections | 6 months | |
| Serum cathelicidin levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MarÃa L Reyes, M.D. | Pontificia Universidad Catolica de Chile | Principal Investigator |
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Las Higueras | Talcahuano | Biobio | Chile | |||
| Hospital de Punta Arenas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39181322 | Derived | Reyes ML, Vizcaya C, Le Roy C, Loureiro C, Brinkmann K, Arancibia M, Campos L, Iturriaga C, Perez-Mateluna G, Rojas-McKenzie M, Dominguez G, Camargo CA Jr, Borzutzky A. Weekly Vitamin D Supplementation to Prevent Acute Respiratory Infections in Young Children at Different Latitudes: A Randomized Controlled Trial. J Pediatr. 2024 Dec;275:114249. doi: 10.1016/j.jpeds.2024.114249. Epub 2024 Aug 22. |
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Dietary Supplement | Placebo liquid |
|
Baseline and after 6 months measurement of serum cathelicidin levels. |
| 6 months |
| serum 25-hydroxyvitamin D levels | Baseline and after 6 months measurement of serum 25-hydroxyvitamin D levels. | 6 months |
| Viral etiology of ARTIs | 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 months |
| Bone metabolism parameters | Baseline and after 6 months measurement of serum parathormone (PTH), alkaline phosphatases, calcium, phosphorus, and urinary calcium/creatinine ratio. | 6 months |
| Punta Arenas |
| Region of Magallanes |
| Chile |
| Pontificia Universidad Católica de Chile | Santiago | Santiago Metropolitan | Chile |
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |