VitDBR2012: Effect of Supplementation With Vitamin D on the Acute Bronchitis Prevention During the First Year of Life

Sponsor

Hospital Universitari Vall d'Hebron Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01875757

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Bronchitis Upper Respiratory Tract Infection Acute Bronchiolitis	Drug: Vitamin D3 Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

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

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Vitamin D3 Drug: Placebo
Active Comparator: 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	Drug: Vitamin D3 Drug: Placebo

Arm

Intervention/Treatment

Experimental: 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

Drug: Vitamin D3

Drug: Placebo

Active Comparator: 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

Drug: Vitamin D3

Drug: Placebo

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Percentage of children with recurrent bronchitis [1 year]
Check that the supplementation of vitamin D of 1,000 units / day decreases the number of recurrent bronchitis

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 19 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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