Effect of Supplementation With Vitamin D on the Acute Bronchitis Prevention During the First Year of Life

Phase 3

Completed

• Conditions: Acute Bronchitis; Upper Respiratory Tract Infection; Acute Bronchiolitis
• Interventions: Drug: Vitamin D3; Drug: Placebo

• Registration Number: NCT01875757
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

A phase III multicenter randomized double blind clinical trial will be conducted. After obtaining written consent the infant will be randomized, during the first two weeks of life, to a study group to receive either 400 IU or 1,000 IU / day of vitamin D to the year of age.

Baseline and all follow up visits (2, 6, and 12 months of life) will include anthropometric measurements and a questionnaire about health issues. A blood sample will be obtained at baseline for analysis of 25OH vitamin D, and at 6 and 12 months for analysis of 25 OH vitamin D, and calcium.

Healthy term born infants of appropriate size for gestational age will be included. We will need to include 359 children in each group.

The primary objective of the study is to decrease the proportion of infants with acute bronchitis during the first year of life by supplementation of 1,000 IU/day vitamin D. Secondary otcomes are: To check that the administration of 1,000 IU/day vitamin D decreases the proportion of infants with upper respiratory tract infections, the proportion of children under one year of age hospitalized for acute bronchiolitis, and the demand on the healthcare system due to respiratory infections and absences from work for parents and achieves a higher proportion of children with adequate blood levels 25 OH vitamin D.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-06-10
• Study First Posted: 2013-06-12
• Study Start: 2013-11
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Healthy term born infants of appropriate size for gestational age
• Parents provide informed consent to participate

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Exclusion Criteria

• Infants with small size for gestational age
• Infants with gestational age < 37 weeks
• Infants with congenital anomalies
• Infants with chronic gastrointestinal tract, liver, kidney, heart, or neurological diseases
• Infants with disorders of vitamin D or calcium metabolism or others inborn errors of metabolism

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D3 1000 IU/day	Placebo	Infants will be supplemented with vitamin D and/or placebo to receive a total amount of vitamin D3 of 1.000 IU/day during the first year of life, taking into account the vitamin D received with artificial milk
Vitamin D3 1000 IU/day	Vitamin D3	Infants will be supplemented with vitamin D and/or placebo to receive a total amount of vitamin D3 of 1.000 IU/day during the first year of life, taking into account the vitamin D received with artificial milk
Vitamin D3 400 IU/day	Vitamin D3	Infants will be supplemented with vitamin D and/or placebo to receive a total amount of vitamin D3 of 400 IU/day during the first year of life, taking into account the vitamin D received with artificial milk
Vitamin D3 400 IU/day	Placebo	Infants will be supplemented with vitamin D and/or placebo to receive a total amount of vitamin D3 of 400 IU/day during the first year of life, taking into account the vitamin D received with artificial milk

Primary Outcome Measures

Name	Time	Method
Percentage of children with acute bronchitis	1 year	Check that the administration of a vitamin D dose of 1,000 U / day decreases the percentage of children with acute bronchitis during the first year of life

Secondary Outcome Measures

Name	Time	Method
Number of episodes of upper respiratory infections reported by parents in the first year of life	1 year	Check that the supplementation of vitamin D of 1,000 units / day decreases the number of upper respiratory infections

Trial Locations

Locations (1)

Hospital Universitary Vall d'Hebron; 🇪🇸 Barcelona, Spain