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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02046577
Recruitment Status : Completed
First Posted : January 28, 2014
Last Update Posted : October 12, 2016
Sponsor:
Collaborators:
National Fund for Research and Development in Health, Chile
Laboratorio Pasteur
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

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.

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Study Type : Interventional  (Clinical Trial)
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 : February 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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 Name: 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 Name: Cholecalciferol

Placebo Comparator: Placebo
Oral placebo in liquid weekly during 6 months
Dietary Supplement: Placebo
Placebo liquid




Primary Outcome Measures :
  1. Incidence of acute respiratory tract infections [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046577


Locations
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Chile
Hospital de Punta Arenas
Punta Arenas, Magallanes, Chile
Pontificia Universidad Católica de Chile
Santiago, Región Metropolitana, Chile
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
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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
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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT02046577    
Other Study ID Numbers: 13-116
Fonis SA13I20173 ( Other Grant/Funding Number: Fondo Nacional de Investigación y Desarrollo en Salud )
First Posted: January 28, 2014    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Pontificia Universidad Catolica de Chile:
Acute respiratory tract infections
vitamin D
cholecalciferol
children
bronchiolitis
pneumonia
prevention
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents