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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Bronchitis Upper Respiratory Tract Infection Acute Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D3 1000 IU/day

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

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DRUG

Placebo

Intervention Type DRUG

Vitamin D3 400 IU/day

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

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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Vitamin D3

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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

Maximum Eligible Age

19 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No